Css Scientific Jobs in Usa

About Us

We are a boutique biologics CDMO located in Newton MA . We are looking for self driven QC expert with technical expertise in biologics who will have end-to-end ownership of QC and EM investigations ensuring they are scientifically rigorous, risk-based, and inspection-ready

Key Responsibilities: 

• Own and close deviations, OOS/OOT, and EM investigations
• Lead root cause analysis and determine appropriate CAPAs
• Assess analytical, microbiological, and biological variability
• Interface directly with QA and cross-functional stakeholders
• Defend the investigation conclusion
• Drive consistency and continuous improvement in investigation practices

Qualifications: 

• BS in Chemistry, Biochemistry, or related field (MS preferred)
• 6–8 years GMP experience with ≥3 years owning investigations
• Strong background in biologics QC and microbiology/EM investigations
• Direct experience in supporting inspections
• Demonstrated ability to make independent, science-based decisions

Position: Associate Director, Clinical Quality Compliance

Location: Bedford, MA (On-site 3 days/week)

Length: 6 Month Contract

Please no agencies. Direct employees currently authorized to work in the United States – no sponsorship available.

Job Description:

The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance. This person will support the clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all clinical and bioanalytical studies. This person will be responsible for establishing our clients inspections management program for GCP inspections and expected to be influential towards maturing the quality culture and help reach a sustained state of inspection readiness. This person will contribute to and execute the Clinical Quality Management Plan for compliance and risk monitoring for all the clinical studies. This person is required to contribute to establishing a scalable Quality Management System that is always ready for inspection. This role requires the person to identify and effectively communicate compliance risks and assist with developing sound strategies and drive action plans to mitigate risks.

Essential Duties and Responsibilities:

• Contribute to the development and maintenance of procedures for the GCP/ GCLP managed activities.
• Partner closely with members of the Clinical Development team to support the successful and compliant execution of clinical studies to meet regulatory requirements, guidelines, internal policies, and procedures.
• Develop and maintain integrated data-driven risk-based quality management plans to monitor the health of compliance.
• Participate in the development of GCP/GLP auditing strategies.
• Support investigations into scientific misconduct and/or serious breach of GCP. Partner with CROs and the clinical study team to analyze investigation findings to identify root/probable cause. Ensure adequate investigation, documentation, and implementation of appropriate CAPAs. Assure timely reporting of potential or confirmed violations, as appropriate, to regulatory agencies.
• Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely regulatory submissions.
• Establish the GCP inspection preparation program and facilitate mock PAI inspections as necessary.

Qualifications:

• BS/BA, MS or PhD and a minimum of 10 years’ experience, respectively, in Biotech, Pharma or CRO.
• Working knowledge of relevant FDA, EU, ICH GCP / GCLP regulations and guidelines.
• Proficient auditing skills with the ability to identify risks based on objective evidence and communicate findings in a sound and factual manner.
• Ability to work autonomously, effectively manage time and deliver results on time.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Conflict resolution/management and negotiation skills.
• Ability to manage multiple projects in a fast-paced environment.
• Excellent organizational, interpersonal, verbal, and written communication skills.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

Come see why DPC has achieved:

• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
• Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!

# 18352

American Cell Technology is seeking a motivated, detail-oriented Laboratory Manufacturing Technician with hands-on experience culturing stem cells or specifically mesenchymal stem cells (MSCs). This is a unique opportunity to work at the cutting edge of regenerative medicine, contribute to a rapidly growing biotech company, and make a real impact in patients' lives.

In this full-time, in-person role, you'll be responsible for:

• Primary stem cell isolation and culture expansion
• Cell characterization and quality control in a GMP-compliant environment
• Ensuring aseptic technique and documentation compliance
• Occasional participation in research, protocol development, or internal R&D projects

What We’re Looking For

We’re looking for someone who:

• Has at least 3 years of hands-on experience culturing stem cells (MSCs strongly preferred)
• Is comfortable working in a GMP-certified cleanroom or equivalent sterile environment
• Brings a scientific mindset with strong attention to detail and documentation
• Demonstrates initiative and enthusiasm for stem cell science
• Is a team player who will positively contribute to company culture and innovation

Schedule & Work Commitment

• Full-time, in-person position (Sunrise, FL)
• Monday–Friday (or other combination of 5 days per week), approx. 44 hours/week
• Flexibility required for occasional weekend or off-hour work depending on lab needs

Compensation & Benefits

• Pay: $18.00 – $30.00 per hour (based on experience & performance)
• Health Benefits: Medical, dental, and vision insurance
• Retirement: 401(k) with employer match

Located in Thousand Oaks, California, 20BLOC is a small privately held development-stage biopharmaceutical company, driven by a mission to create breakthrough protein-based drugs to save lives. Our lead product is an innovative solution to provide oxygen to tissues. Check us out at

We are looking for a motivated and hands-on Head of Manufacturing to join our team.

How you will add value to 20BLOC

The Head of Manufacturing will lead our manufacturing and MSAT teams as we transition from pre-clinical manufacturing and move into our newly built cGMP production facility. This role is responsible for the management and day-to-day oversight of our manufacturing and MSAT functions and will provide strategic direction to the business as we continue to scale and plan for future production needs. The Head of Manufacturing works closely with quality, supply chain, R&D, and other cross-functional teams to ensure product quality, data integrity, and regulatory compliance.

Key Responsibilities

Manufacturing and MSAT Leadership

• Lead Production and MSAT as tightly integrated functions, owning day-to-day manufacturing execution and technical decision-making as the company transitions from pre-clinical operations into a new cGMP manufacturing facility
• Own day-to-day execution of manufacturing operations ensuring safe, compliant, and reliable batch execution
• Establish clear accountability for process ownership including yield, throughput, deviations, and continuous improvement

cGMP Facility and Scale-Up

• Lead manufacturing readiness activities for the new facility including operational readiness, staffing, training, and go-live execution
• Work hands-on with Engineering, Facilities, Quality, and 3rd parties to support equipment qualification and manufacturing area readiness
• Develop manufacturing strategies to support early and late-stage clinical as well as commercial manufacturing for future production and capacity expansion

MSAT & Process Ownership

• Oversee MSAT responsibilities including process characterization, tech transfer, and process validation
• Hold the MSAT team to a high bar for scientific and engineering excellence, ensuring process decisions are grounded in robust data and mechanistic understanding
• Drive data-driven process improvements under manufacturing and analytical data to improve robustness and consistency

People, Strategy, and Organizational Development

• Build, mentor, and develop a high-performing Manufacturing and MSAT team capable of operating in a fast-moving startup environment
• Establish and implement lightweight manufacturing organizational structures, workflows, and standard practices appropriate for a growing GMP operation
• Provide clear technical and operational input to leadership on manufacturing risks, timelines, and scale-up strategy

Education

• Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Chemistry, or a closely related technical discipline required
• Advanced degree (M.S. or Ph.D.) in a related field preferred

Experience

• 8 years+ of experience in GMP manufacturing, MSAT, process engineering, or technical operations within biotech, biopharma, or related regulated manufacturing environments
• Demonstrated experience leading or directly supporting GMP manufacturing operations including hands-on involvement
• Prior experience supporting or leading startup activities in new facilities or new manufacturing suites
• Experience managing and developing small, highly technical teams, preferably in a startup environment
• Experience in early-stage or clinical manufacturing environments (pre-IND through Phase II) strongly preferred

Skills & Competencies

• Strong engineering or related technical foundation, with the ability to reason from first principles about process behavior, risk, and variability
• Hands-on GMP manufacturing expertise, including deviation investigation, root-cause analysis, and process troubleshooting on the production floor
• Data driven decision making, using experimental design and trend analysis of manufacturing data to improve robustness and consistency
• Ability to translate experimental processes into manufacturable GMP operations, balancing rigor, speed, and fit-for-stage execution
• Clear technical and organizational communicator and cross functional collaborator. Able to align operations, engineers, scientists, and leadership around sound technical decisions

Please apply at – in subject line: Head of Manufacturing

This is a full-time, on-site position located in Thousand Oaks, California, and requires working on-site Monday through Friday.All applicants must be authorized to work in the United States. We are not sponsoring employment visas.

Compensation: The salary range for this position is $130,000.00. to $180,000.00 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.

20BLOC is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or other applicable legally protected characteristics.

We offer competitive compensation and benefits including health, dental, vision and life insurance, 401(k) and paid time off.

Duties:

• Routinely monitors, cleans, prepares and operates sophisticated automated cell processing, cell expansion and filling equipment in Grade B/C clean rooms. All required PPE and gowning for classified GMP manufacturing areas are provided by the company.
• Authors and/or revises SOPs that are technically sound, provides clear instructions to align with cGMP requirements, and supports efficient operations
• Successfully troubleshoots processing and equipment issues
• Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls

Qualifications:

• Bachelor’s Degree in Life Sciences Field
• Associates Degree in Life Sciences Field with 1+ years of biotech experience or
• High School Diploma with 2+ years of cGMP experience

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Pay Scale:

$62,000 - $66,560 (Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.

Job Title: Senior Analyst, QC Chemistry

Work Location: Mercer County, New Jersey

Summary:

Perform QC Chemistry laboratory activities with a primary focus on capillary electrophoresis techniques to support GMP manufacturing, testing, and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, and internal processes and procedures.

Responsibilities:

• Perform routine and non-routine testing using capillary electrophoresis techniques (e.g., CE-SDS, CZE, icIEF) in the QC Chemistry laboratory to ensure timely and compliant generation and reporting of in-process, release, and stability test results in support of manufacturing operations.
• Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures.
• Lead troubleshooting efforts for analytical methods and instrumentation related to CE.
• Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.
• Implement corrective actions and preventive actions (CAPAs).
• Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
• Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, test record keeping, etc.
• Maintain equipment in a qualified and calibrated state, coordinating with metrology or vendors as needed.
• Manage inventory of reagents and supplies for the laboratory.
• Participate in internal and external GMP audits, as needed.
• Train other junior level analysts and new hires on CE instrumentation, GMP practices, and data analysis.
• Serving as subject matter expert in one or more areas of required testing.
• Undertake other duties as required.

Qualifications:

• Bachelor’s or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline.
• Minimum of 4+ years of working experience in an FDA-regulated biotechnology or pharmaceutical company.
• CE experience is an absolute must have.
• Familiar with Waters Empower Chromatography Data System.
• Familiar with instrument and equipment validation.
• Working knowledge with USP/EP and cGMP/EU GMP regulations.
• Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.
• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
• Must be willing to travel approximately 10%.
• Ability to work on a computer for extended periods of time.

About GT Molecular

GT Molecular is a fast-growing biotechnology company and Stanford University spin-out headquartered in beautiful Fort Collins, Colorado. We deliver ultrasensitive multiplex digital PCR (dPCR) and qPCR assays powered by our proprietary chemistry—enabling superior sensitivity, robust multiplexing, and reliable detection at low concentrations. Our platforms support end-to-end testing services and commercial kits for oncology research, pathogen detection (SARS-CoV-2, Influenza, RSV, mpox, Polio, Measles, and more), illicit drug monitoring in wastewater, microbial source tracking, and emerging environmental testing (including PFAS/forever chemicals).

Our mission drives public health, environmental surveillance, and cancer research forward. With recent milestones like our CLIA laboratory, CDC's NWSS Multi-Pathogen Assay Development Contract, expanding environmental services, and new hires in lab management and bioinformatics, we're at a pivotal growth stage needing strong operational leadership to scale our proprietary dPCR technology across services and kits.

The Role

In this hands-on role, you will own and scale day-to-day execution across manufacturing, laboratory services, supply chain, quality, and facilities. Reporting directly to the CEO, you'll build professional operations infrastructure to support rapid growth in PCR kit production and NGS / digital PCR testing services - with a focus on high-throughput workflows, operationalizing our proprietary dPCR chemistry for consistent performance, efficiency, compliance, and scalability in a collaborative, mission-driven environment.

Key Responsibilities

• Lead PCR kit manufacturing, including scaling production of multiplex dPCR and qPCR panels incorporating our proprietary chemistry (enzymes, formulations, and reagents); manage supply chain/vendor relationships, inventory, lot-to-lot consistency, and quality to meet demand from CLIA labs, academics, municipalities, and public health partners.
• Optimize operations for microbiology and high-risk testing services, with emphasis on routine wastewater surveillance for pathogens and small molecules (e.g., illicit drugs) using our ultrasensitive dPCR platform and proprietary chemistry in CLIA/high-complexity labs; drive high-throughput workflow efficiency, capacity planning during volume surges, 24–48 hour turnaround, chain-of-custody, and biosafety (BSL-2+) compliance.
• Drive technology transfer from R&D to Operations (including new dPCR assays and chemistry enhancements) and oversee implementation of LIMS systems to enhance throughput, data management, and process automation.
• Collaborate closely with the part-time CLIA consultant (serving as Laboratory Director) and lab teams to integrate lab ops with company-wide processes—focusing on throughput, cost control, resource allocation, and non-technical scaling during growth phases.
• Oversee quality systems and regulatory compliance (CLIA, CAP, ISO 13485, FDA EUA/IVD pathways, or similar highly regulated environments a strong plus), risk management, and continuous improvement across manufacturing and services, ensuring proprietary chemistry integrity and assay performance.
• Drive cross-functional alignment (e.g., quality, facilities, IT, automation, project management) with R&D, sales, bioinformatics, and finance to support revenue growth, forecast needs, and enable new service lines (e.g., deep sequencing and PFAS/environmental testing).
• Build and mentor a growing operations team (production, lab ops, logistics, quality) with experience scaling high-throughput operations preferred.
• Implement tools to eliminate bottlenecks, drive cost/efficiency gains, and manage budgets effectively.

Qualifications

• 8–12+ years of progressive operations leadership in life sciences, ideally in molecular diagnostics, genomics, PCR/NGS manufacturing, clinical/reference labs, or biotech services.
• Leadership of high-throughput core facilities (e.g., NGS, mass spectrometry, proteomics, or molecular diagnostics cores) is a plus, with hands-on experience NGS, PCR multiplex assays, proprietary enzyme/chemistry platforms, pathogen/small molecule detection, technology transfer, and LIMS implementation also valued.
• At least a Bachelor's degree in a relevant field (Biological sciences, Chemistry); PhD, HCLD certification, or MBA preferred.
• Direct experience with validating and introducing molecular assays into a production environment.
• Strong knowledge of regulated workflows and quality/regulatory standards (CLIA/CAP, ISO 15189/13485, FDA oversight, or multi-site lab management a plus).
• Proven ability to deliver fast turnaround in service labs and scale production without compromising quality.
• Excellent leadership, communication, and collaboration skills; comfortable working with scientific founders/CEOs and empowering technical teams.
• Fort Collins/Colorado-based or willing to relocate; excited about public health impact and the collaborative foothills lifestyle.

What We Offer

• Base salary range: $160,000–$220,000 annually, depending on experience and qualifications
• Meaningful equity (ownership in a growing company), performance-based bonus potential, and comprehensive benefits including health, dental, vision, 401(k) with match
• High-impact role with direct CEO access during a key growth phase
• Collaborative culture in scenic Fort Collins—outdoor access, innovative biotech community

How to Apply Send your resume and a brief note on why you're passionate about scaling molecular diagnostics and wastewater/environmental testing operations to (or apply via LinkedIn). Please include "Head of Operations" in the subject line. We encourage diverse applicants.

GT Molecular is an equal opportunity employer. We look forward to hearing from you!

Outside Sales Representative – Regenerative Medicine (Wasatch Front)

Cellcura Sciences

Utah (Wasatch Front focus · in-state only)

 Commission role with $6,000/month base (up to 6 months) + uncapped upside

About Cellcura Sciences

Cellcura Sciences is a Utah-based life sciences company advancing regenerative medicine.

Our flagship product:

• Terminally irradiated, filtered amniotic fluid
• One-year shelf life
• Stored at 2–30°C (simple logistics)

We’re building a lean, execution-focused commercial team and are looking for an outside sales rep who wants to be in the field, build real relationships, and grow with an early-stage company.

The Role

This is a hands-on outside sales role focused on execution

You’ll carry out a defined sales strategy by calling on med spas, clinics, physicians, and regenerative medicine practices across the Wasatch Front. This role is ideal for someone who is energetic, coachable, interested in health and wellness, and motivated by performance-based compensation.

You don’t need to be a subject-matter expert on day one. We’ll train you. You do need to be curious and comfortable learning basic biology and regenerative medicine concepts.

This role can be structured as W-2 or 1099, depending on experience and fit.

What You’ll Do

• Execute a defined sales strategy across the Wasatch Front
• Prospect, schedule, and conduct in-person sales calls with:
• Med Spas
• Clinics
• Physicians
• Surgical and regenerative medicine practices
• Build trust-based relationships with physicians, practice managers, and clinical staff
• Clearly communicate product benefits and differentiation
• Learn and confidently present foundational concepts related to:
• Amniotic fluid
• Regenerative biology
• Support product evaluations, onboarding, and early adoption
• Maintain CRM activity and share field feedback with leadership
• Represent Cellcura Sciences professionally in all clinical settings

Who We’re Looking For

• 1–5 years of outside sales experience
• (medical, device, biologics, pharma, or adjacent B2B preferred)
• Strong interest in health, wellness, and regenerative medicine
• Basic understanding of biology, anatomy, or cell science
• (formal education or self-taught)
• Coachable and comfortable learning scientific concepts
• High energy, self-motivated, and disciplined with territory management
• Professional appearance and demeanor appropriate for physician-facing roles
• Strong communication and relationship-building skills
• Valid driver’s license and ability to travel locally within the Wasatch Front

Compensation & Structure

• Commission-based compensation with uncapped upside
• $4,000/month draw for up to 6 months during ramp up
• Continued employment expected to exceed draw through commissions by month six
• W-2 or 1099 structure depending on experience and fit
• No out-of-state travel required

Why Join Cellcura Sciences?

• Differentiated regenerative product with strong market demand
• Room temperature storage for simple logistics compared to many biologics
• Direct access to founders and leadership
• Opportunity to grow as the commercial team expands
• Performance-based upside without corporate bureaucracy

How to Apply

Submit your resume along with a brief note covering:

• Relevant sales experience
• Interest in regenerative medicine or health sciences
• Any biology, science, or medical background (formal or informal)

LCMS Chemist (Part-Time, On-Site - Houston, TX)

Location: Houston, TX (On-site)

Commitment: 6-10 hours per week (approx. 3 short shifts per week)

Schedule: Flexible

Type: Part-time / Contractor

Industry: Early-stage CRO / Analytical Chemistry

About the Role

We are seeking a hands-on LCMS Chemist to support analytical operations as we establish a CRO capability in Houston. This is a highly flexible, part‑time role ideal for someone who is comfortable working independently, running instruments, and ensuring high‑quality data output.

The position's core responsibility is loading samples, operating the incubator and LCMS system, and generating data. While the day-to-day work is relatively straightforward, expertise working with relevant equipment is essential.

Candidates based in Houston are strongly preferred, as this role requires on-site presence.

Key Responsibilities

• Prepare and load samples into the incubator and LCMS instrumentation.
• Operate a high‑resolution LCMS system for small molecule analysis.
• Perform basic instrument checks and ensure runs are completed successfully.
• Monitor data generation and flag any irregularities.
• Work independently during evening or early‑morning hours, as needed.
• (For senior candidates) Provide additional scientific support or guidance as the CRO capability expands.

Requirements

Must-Have Skills

• Hands-on experience with LCMS instrumentation.
• Experience using an incubator machine in a laboratory environment.
• Ability to work independently and troubleshoot minor instrument issues.
• Comfortable with basic sample preparation and data handling.
• Experience with high-resolution LCMS (HRMS) for small molecules.
• Experience with triple quadrupole (TripleQuad) LCMS-acceptable if not HRMS‑specific.
• Senior-level candidates may contribute to broader CRO setup and operations.
• Prior CRO or analytical lab experience.

Work Schedule & Expectations

• Approximately 5-10 hours per week, typically over two to three short visits.
• Scheduling is flexible as long as work occurs within the 5 PM - 9 AM instrument window.
• Ideal for someone seeking a low‑hour, flexible opportunity while maintaining technical engagement.

Why Join Us

• Opportunity to contribute to the early setup of a growing CRO operation in Houston.
• Flexible working hours and minimal weekly time commitment.
• Autonomy and the ability to shape future lab processes (for senior profiles).

At Afton Scientific, every role contributes to advancing the quality and reliability of sterile pharmaceutical manufacturing. Our team is driven by innovation, collaboration, and a commitment to excellence. We support employees at every stage of their career by fostering an environment where development, learning, and meaningful impact are possible.

We invite you to explore opportunities to join our organization and contribute to our mission. We are currently seeking a Pharmaceutical Operator (II) to support our growing biopharmaceutical operations at our on-site facility in Charlottesville, Virginia. (Relocation Available)

Overview of this Position:

The Pharmaceutical Operator (II) plays a critical role in sterile pharmaceutical manufacturing by operating and maintaining isolator systems for aseptic filling processes. This position ensures compliance with Good Manufacturing Practices (GMP) and supports the production of high-quality injectable drug products in a controlled environment.

Non-Negotiable Requirements:

• At least two (2) years of experience operating isolators in a sterile/aseptic manufacturing facility

• At least two (2) years of experience in a GMP manufacturing facility

• At least one (1) year of experience with routine cleaning, decontamination, and setup of isolators according to SOPs.

•High School Diploma or GED

Preferred Requirements:

• Experience working with Master Control, and/or SAP.

• Experience with cleanroom operations and environmental monitoring

•Experience with automated filling equipment and troubleshooting isolator

•Previous experience in pharmaceutical or biotech manufacturing

•Exceptional attention to detail and communication skills

•Bachelor’s degree in biology and /or Life Sciences

Responsibilities Include:

•Operate isolator systems for aseptic filling of sterile injectable products

•Perform routine cleaning, decontamination, and setup of isolators according to SOPs

•Handle sterile components and materials in compliance with aseptic techniques

•Complete batch records and controlled documentation accurately and timely

•Monitor and document environmental conditions and equipment performance

•Collaborate with Quality Assurance and Engineering teams to resolve issues and maintain compliance

•Participating in training and continuous improvement initiatives

•Maintain a clean and organized work environment in accordance with GMP standards

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. This role may require sitting, standing, or walking for extended periods; using a computer; and working in a standard office environment. Specific physical or environmental requirements will be addressed through the reasonable accommodation process. We do not discriminate based on disability and will provide reasonable accommodation as required by law.

Certified Group is committed to delivering expert solutions and quality testing our customers can feel confident in – on time, every time – so the world can trust in what it consumes. As a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries.

We have embarked on an important journey to unify and strengthen our culture by living these core values: Start with the Customer, Drive to Deliver, Commit to Safety and Quality, and Believe in the Team — including believing in you.

We are currently looking for a Pathogen Lab Analyst to join our growing team!

Job Summary:

Perform analytical and microbiological testing of food products, ingredients, and environmentals. The position performs the application and evaluation of approved microbiological techniques and methodologies.

Essential Responsibilities:

• Accurately perform and read test results and notify Laboratory Management of deviations
• Prepare and analyze samples for indicator organisms, pathogens, and chemistries
• Apply aseptic/microbiological techniques in daily workload
• Report inventory and expendable supplies/materials needed for testing requirements
• Provide routine preventive maintenance by daily cleaning, sanitizing, trash disposal, and equipment quality control
• Assist in quality duties to by taking incubator temperatures, inoculating control organisms, running media controls, etc.
• Pursue an assigned series of processes, procedures, or techniques in accordance with FSNS policies/procedures and customer requirements
• Maintain a high degree of technical competence by reading scientific journals, attending professional workshops, and being aware of food industry issues and trends
• Perform all activities in a neat, safe, hygienic, and efficient manner
• Share information in an open and timely manner
• Assisting with managing priorities and schedule such that individual goals as well as team goals are achieved with encouraged participation in the Food Safety Net Services Team
• Responsible for the safety of oneself and others working within their area

Supervision:

This job does has no supervisory responsibilities.

Education & Experience:

• Associate degree in Life Science or related field with two or more years of laboratory experience, preferred
• Two or more years of experience in a commercial food-testing or analytical laboratory
• Or equivalent combination of education and experience
• Working knowledge of aseptic sampling technique, automated lab equipment, and acceptable methods and procedures
• Familiarity with GLP, OSHA guidelines, FDA, BAM, APHA, ISO, and USP methods and procedures
• Broad knowledge of concepts, practices, and procedures of a food testing laboratory
• Ability to travel when necessary

Physical Demands/Work Environment:

• Dexterity of hands and fingers to operate a computer keyboard, mouse and to handle other communications/computer components
• Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens
• Noise level varies from quiet to loud
• Temperature varies from hot to cold
• Interactive and fast-paced team oriented tasks
• Overnight Travel is required at the discretion of management
• Occasionally lift and/or move up to 25 pounds
• Color vision and depth perception

Benefits:

• Progressive 401k Retirement Savings Plan
• Employer Paid Short- Term and Long-Term Disability, and Life Insurance
• Group Medical
• Tuition Reimbursement
• Flexible Spending Accounts
• Dental
• Paid Holidays and Time Off

Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.

• Own and manage clinical data management activities for assigned early-phase oncology studies, ensuring data quality, integrity, and inspection readiness.
• Serve as the primary owner and administrator of the company’s Medidata platform, including Cloud Admin configuration and maintenance, user access management, etc.
• Provide oversight of EDC builds and updates, including review and approval of database specifications and edit check specifications, completion of UAT, etc.
• Develop and implement data review plans and coordinate ongoing external and internal data cleaning and query management activities.
• Review data listings to support study oversight and decision-making.
• Collaborate cross-functionally with Clinical Operations, Clinical Science, Biostatistics, Medical, and external vendors/CROs to ensure alignment and timely data delivery.
• Monitor data management metrics and reports to ensure compliance with protocols and study plans.
• Contribute to process improvement, SOP development, and inspection readiness activities as the clinical organization continues to scale.
  
  

• Bachelor’s degree in life sciences, data science, or a related field.
• 6+ years of clinical data management experience, with at least 3 years in oncology clinical trials.
• Prior experience in early-phase (Phase 1/1b/2) oncology trials within a biotech or CRO setting.
• Extensive hands-on experience with Medidata including Cloud Admin and Rave EDC.
• Elluminate administration experience a plus
• Strong understanding of CDISC standards.
• Experience working with CROs and vendors, including oversight of outsourced data management activities.
• Working knowledge of GCP, ICH, and regulatory expectations for clinical data.
• Highly detail-oriented with strong organizational and problem-solving skills.
• Adaptable mindset with interest in helping build and scale data management capabilities.
  
  

Reporting to the Regional Sales Director, the Clinical Sales Specialist (CSS) has the opportunity to contribute to the unique and exciting launch of rilonacept in recurrent pericarditis by educating healthcare providers and staff on recurrent pericarditis, drug efficacy and safety, treatment and administration, and patient services. The CSS is responsible for customer account targeting and planning across the assigned territory to maximize the customer and patient experience and deliver on business opportunities for Kiniksa.

Responsibilities (including, but not limited to):

• Develop and execute a strategic territory plan aligned with Kiniksa’s commercial objectives including prioritized territory and account management, business planning and analysis, and resource allocation
• Achieve the commercial goals set for launch
• Always act in a compliant manor with integrity aligned with Kiniksa’s values
• Educate targeted institutional decision makers, cardiologists and rheumatologists on the features, advantages and benefits of rilonacept
• Serve as the primary Kiniksa external representative for key HCP stakeholders , establishing oneself as a reliable, trusted resource for company and product information, appropriate use and dosing
• Drive cross-functional efficiencies and synergy with Kiniksa’s medical and payer field teams
• Identify and build advocacy with influential and respected recurrent pericarditis Thought Leaders
• Maintain updated customer and account profiles including institutional formularies and pathways and payer policies
• Provide a comprehensive overview on Kiniksa’s best-in class Patient Services and support program
• Facilitate collaborative opportunities aligned with Kiniksa’s mission, strategy and objectives through multiple venues, (virtual and in-person where applicable) one-on-one interactions, small group discussions, peer-to-peer programs and presentations with external key stakeholders
• Continuously build and maintain technical and clinical expertise across therapeutic areas and customer needs & expectations (territory market landscape, competitors, market segments/dynamics, disease state) to enable deep scientific discourse externally
• Maintain up-to-date knowledge on customer and healthcare trends within the cardiology space
• Promote a positive organization and brand image as Kiniksa enters the marketplace
• Attend appropriate scientific meetings
• Leverage clinical expertise to educate nurses on the administration of rilonacept
• Comply with applicable laws, internal and external guidelines, policies and procedures that govern Kiniksa activities
• Maintain expenses within assigned budget parameters
• Document field activities accurately and in a timely fashion

Qualifications:

• Requires a Bachelors Degree with 5+ years of biopharmaceutical sales experience; specialty therapeutic experience. Cardiology experience is a plus
• Experience selling and demonstrating reconstitution and injection process is a must
• Candidates must demonstrate a track record of success
• Successfully demonstrated strategic account management experience
• Strong knowledge of the evolving patient and provider landscape
• Demonstrated working knowledge of compliant and ethical business practices
• Must exhibit a strong background in collaborating with internal and external stakeholders
• Must exhibit characteristics that exemplify drive, passion and focus that will translate into significant contributions towards building a global generational company focused on Kiniksa’s patients and customers
• Must demonstrate the ability to effectively & efficiently manage multiple workstreams
• Experience developing and executing a territory strategy with new drug launches preferred
• Must be willing to travel up to 75% of the time (primarily in the assigned territory) and hold a valid driver’s license

Geographic need:

• All Kiniksa new hires whose roles require them to enter Kiniksa’s physical offices will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Kiniksa will consider, among other things whether a proposed accommodation would create an undue hardship.

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• Day to Day:
  
  
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  • This technician will be working on a team that is dedicated to the development of either new web applications or adding functionality to an existing one.
    
  • The initial focus for this person will be UI, and potentially the integration and back-end.
    
  • The organization is modernizing the UI experience for our business operations teams and this team is part of this development journey.
    
  
  
  
• Responsible for analysis, design, programming, and implementation of complex applications tasks and projects.
  
• Devise feasible, logical procedures to resolve business problems through the use of computer resources.
  
• Formulate scope and objectives through research to develop or modify complex systems.
  
• Review detailed specifications and recommend modifications.
  
• Design, code, test and debug complex application programs.
  
• 20% Produce deliverables related to the assigned project.
  
• Perform analysis, design, programming, and implementation of systems and procedures to solve complex business or scientific problems.
  
• Evaluate interrelationships in immediate programming area to determine how changes in one program will affect another related area.
  
• Apply conversions and enhancements to business systems. May lead or provide expertise on assigned projects.
  
• 20% Work closely with customers, business analysts, and team members to understand business requirements that drive the analysis and design of quality technical solutions.
  
• Ensure solutions are aligned with business and IT strategies and comply with the organization's architectural standards.
  
• Assist in post-implementation support and system enhancements.
  
• 20% Test modified programs, create necessary test files and data, verify logic, debug, and write relevant documentation. 15% Design and develop IT systems.
  
• Devise new sources of data and develop new approaches and techniques.
  
• Involved in the full systems life cycle and is responsible for designing, coding, testing, implementing, maintaining and supporting complex application software that is delivered on time and within budget.
  
• 15% Provide guidance to lower-level programmers/analysts.
  
• Act as an internal consultant by providing technical guidance on complex projects.
  
• Determine and resolve problems with other systems analysts, programmers, and systems users.
  
• 10% Test designed programs, verify logic, perform any necessary "debugging," and write the documentation.
  

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• JavaScript
  
• CSS
  
• HTML
  
• Vue.js
  

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• Node.js
  
• OpenShift
  
• UX design experience
  

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• Comprehensive understanding of applications/development, quality assurance and integration methodologies, concepts and facilities in a mainframe, midrange, and/or PC/LAN environment.
  
• Demonstrates a high level of technical proficiency in the areas of programming languages, platform capabilities, and methods of systems analysis and program design.
  
• Excellent analysis, decision-making, and problem solving skills.
  
• Demonstrates logical abstract thinking and assimilating/adhering to project goals and deadlines.
  
• Ability to communicate effectively verbally and in writing.
  
• Able to work well under pressure and as part of a team.
  
• Strong knowledge of interpersonal skills/team building.
  
• Familiar with project management concepts.
  
• Ability to assess requirements, alternatives, and risks/benefits for low- to high-impact projects.
  
• Pays attention to detail.
  
• Ability to establish and maintain effective working relationships with employees, clients, vendors etc.
  
• In-depth understanding of organizational functions, behavior, and inter-relationships.
  

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• Comprehensive knowledge of relevant operating systems, programming languages, and development tools and their usage in the company.
  

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• Communication and collaboration is important.
  
• This candidate will be working closely within a team and quickly completing assignments in an agile environment.
  
• The ability to ask good questions for clarification and understand is important as well. Leadership is a 'nice to have'. If the candidate does have this attribute, they may be asked to develop and share knowledge with other technicians.
  

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• Customer-focused, project-oriented programming environment.
  
• Fast paced, multi-platformed environment which may require action and response 24X7 to support the technical business needs of the customer.
  

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• The Commercial Membership department is a full-stack organization while supporting web-based UI applications that integrate with mainframe applications. We are currently in a transition of developing and training mainframe programmers to be web/full stack developers. The culture is very supportive and collaborative with plenty of challenging work. The specific team the candidate will work on is small with plans to expand and rotate other technicians in and out the team depending on the work and growth opportunities. The candidate will be part of the UI Modernization journey, with an opportunity to shape the future and potential for close collaboration with business partners and technical partners alike.
  

Job Title: Quality Assurance Manager

Job Overview:

Contemporary Staffing Solutions is seeking a Quality Assurance Manager to join our client to lead key quality initiatives that ensure consistent product standards and regulatory alignment. This role champions the development of a strong quality culture, driving improvement across production, documentation, and compliance activities. Based onsite in Coopersburg, PA, this position oversees the daily operations of the QA function while guiding a dedicated team. The ideal candidate brings proven expertise in ISO quality systems and thrives in a fast paced life science environment.

Compensation:

$100,000 – $125,000 annually

Work Schedule:

Monday–Friday, standard business hours

Key Responsibilities of the Quality Assurance Manager:

• Oversee daily QA operations, guiding team members and supporting timely, informed quality decision making.
• Maintain and improve quality systems by monitoring objectives, managing review action items, and ensuring compliance with internal standards.
• Lead or participate in internal and external audits, responding to findings and driving corrective actions.
• Direct the documentation, investigation, and resolution of customer concerns, deviations, nonconforming materials, CAPAs, and change controls.
• Manage product release, supplier qualification processes, material receiving oversight, and the development/review of SOPs and specifications.

Qualifications and Skills for the Quality Assurance Manager:

• Extensive experience (5+ years) in a QA leadership or managerial position within a regulated environment.
• Strong knowledge of ISO 9001 and/or ISO 13485 quality management systems, with experience supporting client or regulatory audits.
• Adept in organizing priorities, communicating clearly, and maintaining meticulous attention to detail while working independently.
• A degree in a science, quality, or compliance related field is preferred; proficiency with Microsoft Word and Excel is essential.

Why Join Us?

This is an opportunity to make a direct impact on quality operations within a growing life sciences organization. You’ll lead meaningful work, collaborate across departments, and help shape long term quality strategies. Candidates who value autonomy, leadership, and continuous improvement will thrive here.

Senior Front-End Developer

Location: Hybrid (Onsite + Remote)

Employment Type: Full-Time

Experience Level: Senior (6+ Years Preferred)

Position Overview

We are seeking a Senior Front-End Developer with strong expertise in modern JavaScript and React to design and build scalable, high-performance web applications. This role requires a hands-on developer with deep technical knowledge, strong architectural understanding, and a passion for delivering exceptional user experiences.

The ideal candidate will collaborate cross-functionally with product managers, designers, and back-end engineers to translate business requirements into maintainable and performant front-end solutions. Experience using AI-assisted development tools in modern workflows is highly valued.

Key Responsibilities

• Design, develop, and maintain responsive web applications using React and modern JavaScript
• Build reusable UI components using functional components and React hooks
• Implement scalable styling solutions using CSS, Bootstrap, and Material UI
• Ensure cross-browser compatibility, responsiveness, and application performance
• Optimize rendering performance, bundle size, and load times
• Collaborate with UX/UI teams to implement designs from tools such as Figma
• Integrate front-end applications with RESTful APIs
• Apply best practices in code quality, testing, and maintainability
• Participate in peer code reviews and provide mentorship to junior developers
• Stay current with evolving front-end technologies and industry trends

Required Qualifications

• Strong proficiency in JavaScript (ES6+), including asynchronous programming and modern language features
• Advanced experience with React:
• Functional components and hooks
• State management patterns (Context API, Redux Toolkit, or similar)
• Component-driven architecture
• Proficiency in HTML5 and semantic markup
• Experience with TypeScript
• Strong CSS3 knowledge, including:
• Flexbox and CSS Grid
• Responsive design principles
• CSS-in-JS and/or modular CSS approaches
• Experience building responsive layouts with Bootstrap
• Experience customizing and theming Material UI
• Experience integrating RESTful APIs (JSON-based services)
• Familiarity with modern build tools and package managers (e.g., Webpack, Vite, npm, yarn)
• Experience with AI-assisted development tools (e.g., coding assistants, AI-based debugging or testing tools)
• Proficiency with Git and collaborative development workflows
• Experience working in Agile/Scrum environments
• Strong debugging, analytical, and performance optimization skills

Preferred Qualifications

• Experience with testing frameworks (e.g., Jest, React Testing Library, Cypress)
• Familiarity with CI/CD pipelines and front-end deployment practices