Commercient Jobs in Usa

452 positions found — Page 7

VP Of Quality and Assurance Compliance
✦ New
Salary not disclosed
Berkeley, CA 1 day ago

Ray Therapeutics, Inc. is a clinical stage biotechnology company developing best-in-class vision restoration therapies for people with degenerative retinal diseases independent of genetic mutation.


We are currently seeking a highly motivated and detail-oriented VP of Quality and Compliance to join our team in the mission to restore vision to patients. This role will report to the Chief Development Officer


The selected candidate will work closely with our Clinical and CMC teams and establish the Quality Department. The VP of Quality and Compliance provides strategic and operational leadership for the Quality Assurance and/or Quality Control functions. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and will require 15-20% domestic travel to our contract development and manufacturing organizations in the United States.


Position Overview:

The VP of Quality and Compliance provides strategic and operational leadership for the Quality Assurance and Quality Control functions. They are responsible for leading all quality control systems, regulatory compliance, and safety, ensuring products/services meet industry standards. They are responsible for clinical and CMC quality requirements, vendor management, internal and external compliance, and ensuring that AAV drug substance and product manufacturing, testing, and release meet FDA, EMA, and ICH regulatory standards, from clinical stage to commercialization.


The Vice President of Quality will establish, lead and develop the quality function, in line with the company's stage, while ensuring global regulatory, industry, and corporate standards are met. Reporting to the Senior Vice President of Regulatory Affairs this position will ensure the organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV). This is a hands-on, strategic, and leadership role, ideal for a seasoned Quality executive passionate about small-molecule therapeutics in a dynamic biotech environment.


Essential Duties and Responsibilities:

  • Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical CROs and CMC CDMO’s
  • Maintain efficient systems and processes that ensure RayTx and its vendor network comply with GXP standards
  • Ensure the appropriate identification, evaluation, and management of risks associated with quality
  • Build strong relationships with stakeholders, representing the company's interests and ensuring compliance with all relevant regulations
  • Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle
  • Manage quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues
  • Lead quality investigations and approve plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations
  • Overseeing the development, implementation, and upkeep of quality systems and procedures, training records, batch records, quality metrics, standard operating procedures (SOPs) pertaining to GXP activities
  • Prior experience establishing a Quality Department and growing a group.
  • Strong knowledge and understanding of clinical trial design.
  • Quality Management System (QMS) Oversight:Develop, implement, and maintain robust quality systems, including document control, change control, deviation management, and CAPA (Corrective and Preventive Actions).
  • Provide expert quality oversight on AAV manufacturing processes, analytical method validations, and comparability studies.
  • Prior experience developing GCP / GMP auditing plans.
  • Regulatory Compliance: Ensure site compliance with global regulations (FDA, EMA) and lead audit readiness efforts (internal and external inspections).
  • Batch Disposition: enact internal quality reviews of GMP batch records, and management of finalization and release of clinical or commercial AAV vectors.
  • Vendor Management: Oversee quality agreements and audits for Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CRO’s).
  • Team Leadership: Mentor and lead quality personnel, fostering a culture of quality, safety, and operational excellence


Qualifications and Experience:

  • Minimum bachelor's degree in relevant scientific or engineering discipline.
  • 8+ years relevant biotech experience.
  • Experience in GMP AAV gene therapy manufacturing preferred.
  • Knowledge of AAV analytical methods and testing preferred.
  • Experience working with CDMO, CRO’s, and other external vendors preferred.
  • Experience with clinical quality oversight, SOP generation
  • Experience with vendor management and audit planning
  • Excellent scientific knowledge and acumen.
  • Familiarity with regulatory requirements and documentation
  • Ability to travel up to 20%


Compensation Range and Benefits:

  • The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
  • Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.


At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.


Search Firm Representatives Please Read Carefully

Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.

Not Specified
Material Handler Operations Lead
✦ New
Salary not disclosed
Memphis, TN 1 day ago
At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.

Job Description

THE POSITION: At our Memphis distribution center, our employees play a critical role in getting life-saving products out to hospitals, clinics and nursing homes. We’re open 24 hours a day, 5 days a week because the needs of patients can’t wait.

The most important aspect of this position is supporting the department Supervisor to ensure team productively executes fulfillment functions for order processing, including picking and packing product, along with manifesting and staging finished shipments per EVERSANA’s standard operating processes. The position also requires the incumbent to be certified on all EVERSANA Mobile Powered Industrial Vehicles (i.e., Forklift, Cherry/Order Picker, Dock Stocker, Electric Pallet Jack, and Bendi Forklift).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Facilitate a safe operational environment by strictly complying with all EVERSANA safety requirements; this includes the accurate completion of pre and post lift truck equipment checklists. 
  • Adhere to all formal standard operating procedures that control the order fulfillment process in specialized areas. 
  • Adhere to all formal standard operating procedures that control the flow of materials through the specialized areas. 
  • Participate in problem solving, if errors or issues occur with operations processes.  
  • Adhere to client specific pack out SOPs. 
  • Perform end of shift inventory checks. 
  • Notify the applicable supervisor or lead of any obstacles to the successful completion of tasks.  
  • Ability to formulate emails to EVERSANA staff as a means of communication 
  • Perform all tasks assigned by Supervisor or Manager.
  • Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
  • All other duties as assigned

POSITION SUCCESS FACTORS: 

  • Ability to direct the workflow while simultaneously working beside material handling team members 
  • Effectively communicate with co-workers and supervisors regarding work requirements 
  • Pays meticulous attention to detail and possesses a task-oriented work ethic 
  • Demonstrates flexibility and a willingness to modify work schedule to support company needs 
  • Ability to successfully complete tasks on a daily basis. 
  • Flexibility and composure in response to changing requirements. 
  • Ability to receive and convey information accurately in a timely manner. 
  • Ability to complete tasks with minimal supervision. 
  • Ability to consistently meet or exceed productivity standards 
  • Ability to safely operate forklift equipment without incident.  
  • Ability to maintain zero defect performance. 
  • Ability to maintain accurate inventory levels of client’s shipping supplies. 

PEOPLE LEADER: People leaders must possess both the skills to effectively accomplish these tasks and the emotional intelligence to do so in alignment with our cultural values. In addition to the critical management and leadership tasks listed above, this role also includes the following unique responsibilities:

  • Day-to-day oversight of associates in partnership with Supervisor.
  • Drive performance-based culture.
  • Recruit and train as needed to ensure compliance and process is routinely followed.

Expectations Of The Job

  • Adherence to all manufacturing requirements including Current Good Distribution Practices (cGDP) and Current Good Manufacturing Practices (cGMP)  
  • Focus on safety at all times and comply with all safety requirements  
  • Follow all formal standard operating procedures (SOPs) that control the order fulfillment process in temperature-controlled areas  
  • Meet all shift requirements as assigned (timely, uniform, etc.) 
  • Hours (Minimum of 40 hours per week, 5 days of the week)

MANDATED UNIFORM: khaki-colored pants, close-toed shoes, and a business casual shirt. Leggings, yoga pants, or any form-fitting stretch pants are not permitted. Shoes should be sturdy and provide full coverage, ensuring no skin or socks are visible through the shoe material. Once the probationary period has concluded (60 days) employees receive an allotment to receive customized EVERSANA uniforms.   

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by an employee with a disability, unless such accommodation would cause an undue hardship for EVERSANA. If reasonable accommodation is needed to perform the essential functions of your job position, please contact Human Resources.

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

An individual in this position must be able to successfully perform the expectations listed above.

Company Benefits And Perks

  • Climate controlled environment
  • Biweekly payroll
  • Medical/Dental Plans
  • Yearly Merit/Performance Incentives
  • Tuition Reimbursement
  • 401 K Plans
  • Company Issued Uniforms

Qualifications

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

  • High school diploma or equivalent (e.g., GED) from an accredited institution inside or outside of the US (will be required to provide official documentation if hired)
  • 2+ years of experience in a fast-paced, distribution warehouse environment or stock room
  • Strong verbal communication skills required  
  • Strong reading, addition, and subtraction skills needed to manage order specific documentation (a calculator may be used)  
  • Ability to follow instructions without deviation required
  • Ability to work the required hours (expect 40hrs/week), in addition to overtime (as needed) 

Preferred Qualifications

  • 3+ years of experience in a fast-paced, distribution warehouse environment with 2+ years of team lead or supervisor experience
  • 1+ years of experience in a pharmaceutical or medical warehouse environment
  • 1+ years of forklift operation experience or equivalent certification
  • Demonstrated ability to independently problem-solve small to medium warehouse operations issues
  • Previous experience coaching and training associates to ensure compliance with SOPs and meet productivity goals
  • Bilingual (English/Spanish) communication skills (written and verbal) are a plus

Warehouse: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Environmental demands include walking or standing at a minimum of 80% of the shift, lifting up to 50 pounds and performing tasking in a busy environment. Bending, squatting, pivoting and stooping may be required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Additional Information

OUR CULTURAL BELIEFS

Patient Minded I act with the patient’s best interest in mind.

Client Delight I own every client experience and its impact on results.

Take Action I am empowered and hold myself accountable.

Embrace Diversity I create an environment of awareness and respect.

Grow Talent I own my development and invest in the development of others.

Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

Communication Matters I speak up to create transparent, thoughtful, and timely dialogue.

Always Innovate I am bold and creative in everything I do.

Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.

EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at /careers. EVERSANA reserves the right to modify this base salary range and benefits at any time.

From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at

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Not Specified
Sr. Mulesoft Developer
✦ New
🏢 EVERSANA
Salary not disclosed
Mason, OH 1 day ago
At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.

Job Description

THE POSITION:

Eversana is currently looking for a Senior MuleSoft Developer with strong technical leadership and hands-on integration experience. In this role, you will drive the design and delivery of high-impact API integrations that support core business processes across Patient Services and Pharmacy. You will be joining a fast paced, supportive, growing, collaborative, and balanced team. You will be transparently communicating to all levels of the organization as well as to clients and partners.

The ideal candidate will bring deep expertise in MuleSoft Anypoint Platform, along with a strong understanding of system interoperability within regulated healthcare and pharmaceutical environments.

Essential Duties And Responsibilities

Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:

  • Design and develop integration solutions using MuleSoft Anypoint Platform.
  • Build APIs (System, Process, and Experience layers) adhering to API-led connectivity principles.
  • Develop RAML specifications, flows, connectors, and error handling strategies.
  • Collaborate with Solution Architects and Business Analysts to align technical solutions with business goals.
  • Develop reusable assets, templates, and reference implementations to support platform scalability and maintainability.
  • Ensure compliance with data privacy and security regulations (HIPAA, HITRUST) and support GxP validation processes.
  • Support CI/CD automation, monitoring (e.g., Splunk, CloudWatch), and error handling strategies for production readiness.
  • Participate in sprint ceremonies and contribute to platform roadmap, capacity planning, and performance tuning.
  • Provide production support, troubleshooting, and issue resolution for integration services.
  • Strong analytical and problem-solving skills.
  • Experience using Agile, Scrum and iterative development practices
  • Mentor and enable other members of the team.
  • Collaborate with business and technical stakeholders as needed for gathering requirements, deliver integration solutions.
  • Be able to work independently on a project but also collaborate with other solution architects, Leads and stakeholders to exchange information and expand overall knowledge in the practice
  • Manage time expeditiously in a fast paced, growing, and continuously changing environment. Be able to focus on delivery regardless of environmental distractions
  • All other duties as assigned
  • Good to have MuleSoft Integration/Platform Architect certification

Expections Of The Job

  • Enjoys working on multiple projects at a time
  • Be able to communicate at all levels of the organization
  • Continuous learner and Team player
  • Strong communicator at all levels of the organization and to clients and partners

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

An individual in this position must be able to successfully perform the expectations listed above.

Qualifications

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

  • BS in Computer Science, Analytics, Business Intelligence, related field or equivalent experience
  • Strong prior IT background as a developer, technical analyst, application support and or administrator
  • Relevant experience in MuleSoft 5+ years
  • Strong grasp of API architecture (System, Process, Experience), RAML/OpenAPI, OAuth2, and integration best practices.
  • Strong understanding of agile and waterfall project delivery methods
  • Excellent problem-solving skills, communication, and cross-functional collaboration.

Preferred Qualifications

  • Integration Architecture experience strongly preferred
  • Experience with Anypoint platform and designing integrations using Mulesoft strongly preferred
  • Health care (provider, pharmaceutical, and/or health plan) experience strongly preferred
  • MuleSoft Certified Developer (Level 1) and/or Integration Architect certification.
  • Exposure to microservices, containerization (Docker, Kubernetes), and service mesh architecture.

Physical/Mental Demands And Working Environment

The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands.

Additional Information

OUR CULTURAL BELIEFS:

Patient Minded I act with the patient’s best interest in mind.

Client Delight I own every client experience and its impact on results.

Take Action I am empowered and empower others to act now.

Grow Talent I own my development and invest in the development of others.

Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

Communication Matters I speak up to create transparent, thoughtful and timely dialogue.

Embrace Diversity I create an environment of awareness and respect.

Always Innovate I am bold and creative in everything I do.

Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.

EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at /careers. EVERSANA reserves the right to modify this base salary range and benefits at any time.

From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at

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Not Specified
Associate Chemist
✦ New
Salary not disclosed
Chesterfield, MO 1 day ago

Role is with a formulation and delivery team. Will work with research scientists in developing next generation herbicide products and in supporting both R&D activities, and to some extent, commercially launched products.


Evaluates the chemical and physical properties of various organic and inorganic substances in order to investigate their applications in formulated products.


Requires a bachelor's degree and at least 1 year of experience in the field or in a related area.


Has knowledge of commonly used concepts, practices, and procedures within a particular field.


Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision. Typically reports to a supervisor or manager.


Diligently records all laboratory tasks performed and related procedures and findings in electronic laboratory notebook system.


Requires hands-on lab experience and interest in doing lab work.


Will work on various projects and follow SOP's and basic lab techniques, using equipment that includes - e.g., pH meters, mixers/agitators, homogenizers, and milling equipment.


***Rheometer and interfacial measurement experience is a plus, as is proficiency in chemistry/chemical engineering principles, including mass-balance calculations.


Some industrial experience in formulation development preferred -e.g., with pesticides, foods, cosmetics, consumer products, and/or paints & coatings.

Not Specified
Scientist/Senior Scientist, Peptide Discovery and Development
✦ New
Salary not disclosed
Rockville, MD 1 day ago

HANSOH BIO

Hansoh Bio is a U.S.-based subsidiary of Hansoh Pharmaceutical Group Company Limited, a biopharma company founded in 1995. Hansoh Pharma discovers and develops breakthrough therapies for serious diseases and disorders affecting patients around the world, employing 9,000 workers and 1,400 R&D professionals. With over 40 products in commercialization, the Company’s pipeline programs and products cover therapeutic areas such as oncology, central nervous system, anti-infectives, diabetes, as well as gastrointestinal and cardiovascular diseases.

Hansoh Bio is a biotech Research and Development (R&D) arm of Hansoh Pharma based in Rockville, MD, focused on de novo drug discovery and development of novel therapeutics. Hansoh Bio is thrilled to offer exciting opportunities for researchers and scientists to engage in target discovery and pre-clinical candidate development of high impact projects, while being an integral member of a collaborative, passionate, and goal-oriented team.

For more information, please visit Biology and Biophysics – MARYLAND R&D CENTER

We are currently seeking a motivated and multi-talented scientist to join our peptide discovery and development team in Rockville, Maryland. This role will focus on the design, screening, and optimization of peptide-based ligands against biologically relevant targets. The successful candidate will contribute to the development of innovative screening platforms and drive hit-to-lead and lead optimization efforts toward preclinical candidate selection.

This position requires a strong foundation in protein–ligand interactions, peptide chemistry/biology, and a demonstrated ability to integrate experimental and computational approaches.


RESPONSIBILITIES

• Develop novel screening strategies to identify peptide binders

• Drive optimization of peptide hits for affinity, selectivity, stability, and developability

• Leveraging computational tools (e.g., molecular modeling, docking, MD simulations) to inform peptide design

• Apply structure activity relationship principles to guide iterative design cycles

• Interpret structural biology data (e.g., X-ray, cryo-EM, AlphaFold models) to guide optimization strategies

• Work closely with biophysics, structural biology, medicinal chemistry, and in vivo pharmacology teams

• Provide timely communication and presentations


REQUIREMENTS

• Ph.D. degree in biochemistry, biophysics, molecular biology or related areas with 5+ years of research experience. Post-doctoral experience is preferred but not required

• Familiarity with computational chemistry or structural modeling tools

• Strong experience in molecular biology such as RT-PCR, qPCR, etc

• Strong experience in expression, purification, and biophysical characterization of proteins

• Strong understanding of protein–ligand interactions and binding kinetics

• Hands-on experience with biophysical binding assays (SPR, BLI, ITC, etc.)

• Experience with peptide discovery platforms (e.g., phage display, mRNA display, yeast display) is preferred

• Experience in SAR-driven optimization and lead development is preferred

Not Specified
Clinical Research Associate
✦ New
Salary not disclosed
Scottsdale, AZ 1 day ago

Primus Pharmaceuticals is seeking a versatile Clinical Research Associate (CRA) to support the conduct of prescription medical foods clinical trials at a growing pharmaceutical company. This role offers a mix of remote monitoring, site activities, and in-office collaboration at our Scottsdale headquarters. This role is ideal for a professional who enjoys both hands-on site engagement and strategic oversight responsibilities in a fast-paced environment.


Primus is an innovative company with novel products based on unmet needs that empowers providers and patients with prescription brands that maintain the highest level of safety without compromising efficacy. We are scaling proven brands into their next chapter, and the ideal candidate will find this motivating and have the leadership and skills to drive results.


Position Overview

The CRA will collaborate closely with Primus, the vendors, and investigative sites to ensure high-quality, compliant study execution. This role requires effective communication, and the fostering of strong site relationships and operational excellence.


Roles & Responsibilities

Vendor & Site Oversight

  • Provide operational oversight of monitoring activities, including the development of monitoring visit reports, follow-up letters, and issues escalation.
  • Track site and vendor performance against key deliverables, KPIs, and study timelines.
  • Review Trial Master File (TMF) content for accuracy and completeness.
  • Contribute to study-specific documents, including monitoring, communication, and risk management plans.


In-Field & Site Monitoring

  • Conduct qualification, initiation, interim monitoring, and close-out visits at investigational sites as needed.
  • Verify informed consent documentation, source data, case report forms (CRFs), investigational product accountability, and protocol compliance.
  • Identify and resolve protocol deviations, compliance issues, and data discrepancies directly with site personnel.
  • Serve as the primary point of contact for assigned sites, building strong relationships with investigators and staff.
  • Provide ongoing training and support to sites on protocol requirements, study tools, and GCP compliance.


Cross-Functional Support

  • Collaborate with internal teams (Clinical Development, Regulatory, Data Management, Safety, Quality) to ensure aligned trial execution.
  • Support the design, development, and refinement of essential clinical trial documents, including Case Report Forms (CRFs), monitoring plans, and study-specific instructional manuals.
  • Support audit/inspection of readiness and contribute to corrective/preventive action (CAPA) planning.
  • Assist in site and vendor governance meetings by providing operational feedback and insights.


Qualifications

Education & Experience

  • Bachelor’s degree in life sciences, nursing, pharmacy, or related field. (Requirement may be waived for candidates with 5+ years of directly relevant professional experience) .
  • 3–6 years of clinical research experience, including at least 2 years as a CRA.
  • Experience in both site/vendor oversight and direct site monitoring (pharma, biotech or CRO background preferred).

Technical Skills

  • EDC Proficiency: Strong technical experience using Electronic Data Capture (EDC) platforms for data entry, query management, and source data verification (SDV).
  • Platform Knowledge: Familiarity with industry-standard platforms such as Medidata Rave, Veeva Vault EDC, JotForm or Medrio.
  • Compliance: Deep knowledge of ICH-GCP, FDA regulations, 21 CFR Part 11, and standard clinical trial processes.

General Skills

  • Demonstrated ability to manage multiple sites/trials across various therapeutic areas.
  • Excellent communication, organizational, and problem-solving skills.
  • Willingness to travel (approximately 10–20%).
  • Comfortable working in a smaller pharmaceutical setting with the flexibility to take on broad responsibilities.


About Primus Pharmaceuticals, Inc.

Primus innovates in prescription nutritional therapies targeting metabolic causes of chronic diseases across rheumatology, dermatology, and women’s health. We develop and commercialize first-in-class products and novel deliveries in Rx drugs, medical foods, and medical devices to fill key unmet needs with universal patient access not provided by traditional pharma. Visit our website at

Not Specified
Global Support Specialist I
✦ New
🏢 EVERSANA
Salary not disclosed
Overland Park, KS 1 day ago
At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.

Job Description

THE POSITION:

As a Global Support Specialist l, you will be using your technical and customer service skills to deliver technical support services. We'll rely on you to keep staffers and our business running smoothly. You will be the first point of contact for our service requesters and the face of IT. You'll be using your multi-tasking expertise to provide superior customer service support for desktop, laptop and mobile device issues. You will be relied upon to provide level one issue resolution, service call creation and issue classification.

Essential Duties And Responsibilities

Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:

  • Performing entry level IT tasks which includes password resets, basic system configuration troubleshooting, and initial application access or performance analysis.
  • Routing incoming incident and service requests to the appropriate support group
  • Maintaining accurate and timely records in issues tracking system
  • Maintaining service desk knowledgebase support documentation
  • Participating in professional development and team improvement initiative
  • Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
  • All other duties as assigned.

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by an employee with a disability, unless such accommodation would cause an undue hardship for EVERSANA. If reasonable accommodation is needed to perform the essential functions of your job position, please contact Human Resources.

Expectations Of The Job

  • Individual will be expected to analyze end user hardware, operating system and business application issues
  • Communicate professionally and effectively with users to understand issues and propose solutions
  • Effectively manage service desk workload to meet publishing business SLAs
  • Regularly attend team meetings and provide content relating to current project status and knowledge transfer activities
  • Must have the ability to address system issues both on and off hours.

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

An individual in this position must be able to successfully perform the expectations listed above.

Qualifications

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

  • Minimum of 1-year technical support experience with superior customer service supporting desktops, laptops, mobile devices and related applications within an ITSM service desk system

Preferred Qualifications

  • Knowledge of Windows Server environment, Windows desktop, terminal server/thin client deployment, hardware troubleshooting, network security, network administration and phone systems
  • Knowledge of Microsoft 365 and Office applications
  • Knowledge of Apple IOS and OSX environments
  • Experience using an IT Service Desk platform, preferably Service Now.
  • Knowledge of network connectivity, protocols and security devices to include VPN troubleshooting
  • Ability to be on-call for critical off-hours support
  • Experience in the life science or health industry is a plus

Physical/Mental Demands And Working Environment

The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands.

Additional Information

OUR CULTURAL BELIEFS:

Patient Minded I act with the patient’s best interest in mind.

Client Delight I own every client experience and its impact on results.

Take Action I am empowered and empower others to act now.

Grow Talent I own my development and invest in the development of others.

Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

Communication Matters I speak up to create transparent, thoughtful and timely dialogue.

Embrace Diversity I create an environment of awareness and respect.

Always Innovate I am bold and creative in everything I do.

Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.

EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at /careers. EVERSANA reserves the right to modify this base salary range and benefits at any time.

From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at

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Not Specified
R&D Project Manager
✦ New
Salary not disclosed
San Diego, CA 1 day ago

Immediate need for a talented R&D Project Manager. This is a 12+ months contract opportunity with long-term potential and is located in San Diego, CA(Hybrid). Please review the job description below and contact me ASAP if you are interested.


Job ID:26-08555


Pay Range: $60 - $90/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).


Key Responsibilities:


  • Lead and manage multiple R&D programs and/or large-scale product development projects, from feasibility through commercialization, including Class II and/or Class III medical devices (with emphasis on electrically active/medical electrical equipment where applicable).
  • Develop and maintain integrated program plans, timelines (Gantt charts), budgets, resource plans, and risk registers; proactively identify and mitigate risks across technical, regulatory, clinical, commercial, and electrical safety dimensions.
  • Define project scope, objectives, deliverables, and success criteria; create and maintain project charters, work breakdown structures (WBS), and detailed schedules.
  • Lead cross-functional core teams (R&D/Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, Marketing, and Operations) to execute program objectives; facilitate effective decision-making and resolve conflicts.
  • Drive adherence to Design Control processes (21 CFR 820.30), risk management (ISO 14971), usability engineering (IEC 62366), basic safety and essential performance requirements for medical electrical equipment (IEC 60601-1 series), and other applicable standards throughout the product lifecycle.
  • Provide regular status updates, executive-level reporting, and dashboards to senior leadership and stakeholders; communicate program progress, issues, decisions, and changes clearly and proactively.
  • Support regulatory strategy development and submissions (e.g., 510(k), PMA, technical files for CE marking), including coordination of electrical safety testing, EMC compliance (IEC 60601-1-2), and collateral/particular standards as needed.
  • Foster a collaborative, innovative, and compliant culture within program teams.
  • Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and cross functional teams management.
  • Lead cross-functional teams through identification of risks & mitigations, problem resolution and root cause analysis, corrective and preventive action.
  • Develop and maintain integrated project plan with risk-based timeline, critical path milestones, resource allocation, roadmap with clear milestones for gap analysis, risk management, remediation, testing, certification and budget tracking to support certification goals
  • Monitor the effectiveness and performance of the launch and project team and facilitate the development of contingency plans, recommending corrective actions as required.
  • Ensure compliance with quality management systems and regulatory requirements, where applicable.
  • Lead the team to prepare for and execute Phase Gate. Represent the team with Client leaders, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data.
  • Leverage technical acumen to partner with engineering teams, monitor development progress, and ensure alignment between technical deliverables and program timelines
  • Drive design control discipline throughout product development, ensuring compliance
  • Conduct or oversee gap assessments against general, collateral, and particular standards for medical electrical equipment safety and essential performance.
  • Manage integrated risk management (per ISO 14971), including essential performance definition, hazard analysis, risk controls, and verification.
  • Coordinate and manager the execution of test plans for electrical safety, EMC, mechanical, environmental, and essential performance requirements; coordinate pre-compliance and formal third-party testing.
  • Oversee compliance documentation: technical files, risk management files, test reports, essential performance rationale, and certification justification.
  • Integrate compliance activities with the quality management system (ISO 13485) and other regulatory requirements (FDA, EU MDR, etc.).
  • Serve as primary liaison with notified bodies, test labs, and regulatory consultants to support certification and post-compliance needs.
  • Drive a safety-focused culture while ensuring the team meets the September 2027 compliance target


Key Requirements and Technology Experience:


  • Key Skills;Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, or related),Life Sciences, or equivalent.
  • 3-5 years of project management in medical devices, with ≥5 years leading compliance programs for medical electrical equipment.
  • Proven track record of successfully delivering medical device programs from concept to market launch (including regulatory clearance/approval).
  • Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971 risk management, IEC 62304 (software), and global regulatory pathways (510(k), De Novo, PMA, MDR).
  • Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet, or similar) and standard office software.
  • Project Management Professional (PMP) certification not required but is preferred
  • Scrum Master and SAFE Agile certification is preferred.
  • Experience in medical device industries required, including experience in FDA or other regulated environments.
  • Knowledge of the medical device industries beneficial integrating science and technology into business processes.
  • Technical background in electrical, mechanical, or biomedical engineering
  • Expert in the development and deployment of program management tools and techniques including methods for tracking progress, risk management and delivery of major milestones.
  • Understanding of engineering development lifecycles and the ability to translate technical inputs into program-level actions and timelines
  • Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, external partners, geographies, and cultures.
  • Drive for accountability within self and others.
  • Proven project management experience with delivering medium-to large-scale projects in managed service model from concept through delivery and operations
  • Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements.
  • Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality.
  • Direct experience with major test labs and certification bodies for medical electrical equipment standards.
  • Experience with programmable electrical medical systems (PEMS) or software-inclusive devices (IEC 62304 knowledge a plus)
  • Proven success taking Class II (or higher) active medical electrical devices from gap assessment through third-party certification.
  • Strong knowledge of ISO 14971, ISO 13485, general/collateral/particular standards for medical electrical safety and essential performance, and EMC requirements.
  • Familiarity with FDA QSR (21 CFR Part 820), EU MDR/IVDR, or other global regulations.


Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.


Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.


By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

Not Specified
Senior Contract Manager
✦ New
Salary not disclosed
McKinney, TX 1 day ago

Netrio is a leading MSP in North America, specializing in IT solutions for mid-market to enterprise customers. We serve over 1,000 clients across industries with services including managed IT, cybersecurity, cloud, connectivity, voice, and custom application development.


Position Summary

The Senior Contract Manager oversees the full contract lifecycle, ensuring agreements are compliant, commercially sound, and aligned with organizational goals. This role acts as a strategic partner to business units, providing expert guidance on contract negotiation, risk management, and performance monitoring.


Key Responsibilities

  • Lead the drafting, review, negotiation, and execution of complex commercial, vendor, and client contracts.
  • Ensure compliance with legal, regulatory, and company policy requirements.
  • Identify and mitigate contractual risks while maximizing business opportunities.
  • Collaborate with legal, procurement, finance, and operational teams to align contract terms with business objectives.


Qualifications

  • Bachelor’s degree in Law, Business Administration, or related field (Master’s or JD preferred).
  • 7+ years of contract management experience, with at least 3 years in a senior or leadership role.
  • Strong knowledge of contract law, commercial terms, and negotiation strategies.
  • Exceptional communication, analytical, and problem-solving skills.
  • Proficiency in contract management software and MS Office Suite.
contract
Materials Planner / Account Manager
✦ New
Salary not disclosed
Portage, IN 1 day ago

MSI Express is a single-source contract manufacturing and packaging company, delivering innovative engineering solutions from our strategically located network of manufacturing facilities.



ROLE PURPOSE/ POSITION SUMMARY

The Account Manager is responsible for managing and maintaining strong relationships with customers, ensuring timely and accurate processing of orders, and overseeing the efficient flow of materials to meet customer demand. This role involves collaboration with internal teams, such as production, logistics, and quality control, to ensure efficient plant operations and exceptional customer satisfaction.


KEY ACCOUNTABILITIES/PRIMARY DUTIES & RESPONSIBILITIES

Customer Relationship Management

  • Build and nurture strong, long-lasting relationships with customers
  • Understand customer needs, preferences, and expectations to provide personalized service
  • Ensure customer reports and information are accurate and communicated to customer in a timely fashion
  • Interface into customer reporting systems (i.e., SAP, Oracle for scheduling, production, -most times by lot control), shipping, receiving, and managing procurement of customer owned raw materials for specific customer assigned
  • Assist in new product launches, collaborate with commercialization team, and site team to meet with timelines and other targets
  • Handle customer issues & complaints by referring the issue to the appropriate department & logging them onto the system. Follow up to resolution

Order Processing

  • Receive and process customer orders accurately and efficiently
  • Verify order details, including quantities, specifications, and delivery schedules
  • Prepare job files and project specifications for internal processing and manufacturing for specific customer assigned
  • Track order fulfillment & communicate shorts to our customers with information on when product will be available

Material Inventory Management

  • Participate in material planning process
  • Drive change in managing inventory levels and inventory turns and minimizing obsolescence, scrap, aged inventories, and inventory reserves
  • Analyze production yield, material usage, and material loss data to understand customer/material impacts
  • Coordinate with production and procurement teams to ensure optimal inventory levels

Supply Chain Coordination

  • Collaborate with internal supply chain teams to ensure timely procurement of raw materials and ingredients
  • Oversee the supply of raw and packaging materials (whether customer or organization owned) for the facility to include new production to meet production schedules
  • Coordinate with logistics teams to facilitate on-time deliveries to customers

Problem-Solving

  • Identify and address customer-related supply chain issues promptly and effectively
  • Resolve order discrepancies, shipping delays, or quality concerns in collaboration with relevant teams

Communication

  • Maintain clear and open communication with customers regarding order status, changes, and potential issues
  • Collaborate cross functionally with internal teams to convey customer requirements and expectations

Negotiation and Contract Management

  • Negotiate terms, pricing, and delivery schedules with customers
  • Manage contracts and agreements to ensure compliance with terms and conditions

Data Analysis

  • Utilize data and analytics to track order performance, customer buying patterns, and inventory levels
  • Provide insights to management for strategic decision-making

Quality Focus

  • Ensure that materials and products meet quality control standards before delivery to customers
  • Collaborate with quality control teams to address and resolve any quality issues

Continuous Improvement

  • Identify opportunities for process optimization and efficiency improvements within customer material account management
  • Stay informed about industry trends and best practices
  • Participate and assist in development of new, effective programs/policies for customer, supplier, transportation, and logistics management in conjunction with Supply Chain and plant leadership
  • Perform other duties as assigned


QUALIFICATIONS/ CAPABILITY PROFILE

Minimum Education

  • High school diploma or GED
  • Bachelor’s degree in related field

Minimum Experience

  • Four plus (4+) years of experience in purchasing or material planning, purchasing, materials management
  • Food manufacturing experience
  • Demonstrated track record in improving inventory accuracy, driving inventory reduction strategies and reducing premium freight
  • Strong Math and Typing Skills
  • Basic level of business acumen, strong attention to detail and analytical skills

Minimum Knowledge/ Skills/ Abilities

  • Working knowledge of manufacturing, material flow and improvement strategies and the ability to integrate those into the operation
  • Excellent organizational and people skills, project management skills, with an ability to openly convey information to team members in a timely, concise manner
  • Understanding of applicable computer systems, such as Microsoft Office, Nulogy, Tableau, etc.
  • Leadership
  • Budget Management
  • Vendor/Contractor Management
  • Metric Development
  • Ability to identify and propose potential solutions to production
  • Demonstrated Understanding of Materials Management


- Inc. 5000 #124 fastest growing company in the Midwest. (2025)

- Inc. 5000 #10 fastest growing company in the Midwest. (2022)

- Inc. 5000 #165 fastest growing company in the Midwest. (2021)

- Inc. 5000 #1,085 fastest growing company in the USA. (2023)

- Inc. 5000 #622 fastest growing company in the USA. (2022)

- Inc. 5000 #479 fastest growing company in the USA. (2021)

Not Specified
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