Css Scientific Address Jobs in Usa

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• You will join a team of seven scientists responsible for producing pilot-scale biological products that support biologics programs, trouble shooting and improving processes. The team implements new technologies to enhance operational capability, capacity, and efficiency across the site.
  

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• Technical & Operational
  
• Plan and execute downstream purification and scale-up activities including filtration, chromatography, and buffer preparation.
  
• Support upstream operations as needed to ensure seamless end-to-end process execution.
  
• Monitor, analyze, and interpret process and performance data; prepare clear summaries of findings as appropriate.
  
• Maintain laboratory readiness, including equipment maintenance, analytical instrument upkeep, consumable inventory management, and general lab support.
  
• Communication & Collaboration
  
• Present data, results, and conclusions in group meetings and cross functional discussions.
  
• Communicate technical information clearly and effectively to colleagues at varying levels.
  
• Work with a team-oriented, collaborative, and solutions-focused mindset.
  
• Maintain a strong safety focus in all laboratories and pilot operations.
  

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• Hands-on experience with downstream purification operations, including centrifugation, chromatography, TFF, and depth filtration.
  
• Proficiency with AKTA systems and UNICORN programming.
  
• Practical experience in chromatography column operations, including resin packing and unpacking at various scales (e.g. 4.4 to 30 cm internal diameter columns).
  
• Strong verbal communication, technical writing, and documentation skills.
  
• Ability to work effectively in cross functional teams and in a dynamic environment.
  
• Self-motivated, organized, and comfortable with scientific problem solving.---
  

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• Experience in pilot plant operations for biologics in a single-use facility.
  
• Familiarity with Process Development and/or current Good Manufacturing Practices (cGMP), technology transfer, plant operations, and bioprocess scaleup principles.
  

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• AA/AS degree with 2+ years of relevant industry experience (purification techniques), or
  
• BS/BE in Chemical/Biochemical Engineering, Biochemistry, Biology, or related discipline with 1+ year of relevant experience.
  

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• Initial Zoom screening, followed by 1:1 interview with the hiring manager and 1-2 team members.
  

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• Onsite
  

Job Title: Intellectual Property Attorney - Associate General Counsel and Patent Counsel

Location: Hybrid -Rockville, Maryland, United States

Salary: $150,000-$325,000

Skills: Patent Law, Trademark Law, Molecular Biology or Computer Science, Licensing, Agreements

About the Biotechnology Company / The Opportunity:

We are a growing life sciences company that is expanding its Intellectual Property (IP) team and hiring for multiple IP-focused roles, including a patent counsel, an IP-focused associate general counsel, and an IP transactional associate general counsel. In these roles, you will work closely with inventors, internal teams, and external counsel to protect the company’s intellectual property and support innovation. This is a unique opportunity to support cutting-edge research and help protect the company’s valuable innovations.

Responsibilities:

• Provide legal counsel on intellectual property matters including patents, trademarks, copyrights, trade secrets, and IP licensing.
• Manage patent portfolios, including drafting, filing, prosecuting, and maintaining domestic and international patent applications.
• Review, draft, and negotiate commercial contracts, including licensing, collaboration, supply, and material transfer agreements, with a focus on IP terms.
• Advise on IP strategy, risk mitigation, and enforcement, including potential litigation support.
• Collaborate with inventors and internal teams to support R&D, product development, and commercialization.
• Provide guidance and training to internal teams on IP protection, agreements, and best practices.

Must-Have Skills:

• Juris Doctorate degree from an accredited law school and a current license to practice before a state bar and admittance to practice before the United States Patent and Trademark Office (USPTO) for Patent Counsel.
• 7-10+ years of combined legal experience at USPTO, law firm, or in-house legal team.
• Deep understanding of patent, trademark, copyright, and trade secret law and strong ability to manage complex IP portfolios and matters independently.

Nice-to-Have Skills:

• Advanced degree (MS or PhD preferred) in molecular biology, mechanical engineering, computer science, or related field, with at least 3 years of research or product development experience.
• Technical or scientific background in molecular biology, mechanical engineering, computer science, or related fields.

Job Title: Scientific Researcher

Location: South San Francisco, CA 94080 (on-site)

Duration: 04/06/2026 to 03/30/2027

Job Description:

** To support Formulation Screening efforts within the Synthetic Molecule Pharmaceutical Sciences

** To contribute to the Development and Optimization of Lipid Nanoparticles (LNPs) and other Parenteral Formulations through high-throughput screening strategies and advanced analytical characterization.

Required Qualifications:

* BS or MS degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry

* 1 - 5 years of Industrial experience in Pharmaceutical Formulation Research and Development.

Key Skills:

* Pharmaceutical formulation development

* LNP and Parenteral Formulations (Lipid Nanoparticles = LNPs)

* Analytical Chemistry techniques

* Hands-on experience with robotic liquid and solid handlers.

* Hands-on experience with Analytical tools: UV/Vis/Fluorescence, Spectroscopy, HPLC, CE

Virology – Scientist / Associate Scientist

Location: Seattle, WA (onsite)

Company: Stealth mode biotech

About the Company

We're an early-stage, venture-backed biotech operating in stealth mode. We're building a nimble team that thrives in ambiguity, moves quickly from idea to experiment, and collaborates closely across science and operations to inform decision-making.

The Opportunity

This is a hands-on, high-impact role within our virology group. You will work under the supervision of a senior scientist, contribute to day-to-day operations and data quality, and directly support DC candidate selection and product characterization.

What You'll Do:

Support virology lab operation

• Support BSL-2/BSL-2+ operations, including procurement, instrument commissioning/qualification, biosafety practices, inventory, sample tracking (ELN/LIMS), and facility/vendor interfaces.

Neutralization & titering assays

• Establish, execute, and troubleshoot in vitro neutralization assays under guidance, using reporter virus (e.g., luciferase/fluorescence readouts) and immunostaining formats.
• analyze and interpret IC50; establish acceptance criteria, controls, and data QC for reproducible decision-making.
• Contribute to potency assay development, optimization, qualification, and transfer in alignment with ICH guidelines.

Viral stocks generation and characterization

• Create and manage master seed / working pools for characterized mutant strains as needed.
• Perform plaque purification across multiple rounds to isolate pure clones; confirm clonality and fitness characteristics prior to scale-up.

Cross-functional impact

• Partner closely with protein sciences, discovery biology, and external CROs to align assay timelines, materials, and data packages; present crisp summaries and recommendations to senior leadership.
• Provide scientific input to bioanalytical (bioA) assay strategies (e.g., ligand-binding PK/PD, titer, ADA/neutralizing antibody) in partnership with CROs.
• Author technical reports and contribute to regulatory submissions

What You'll Bring:

Minimum qualifications

• B.S or M.S. with 2+ years of hands-on experience in virology, microbiology, molecular biology, or related field (industry preferred).
• Demonstrated expertise with reporter virus or immunostaining neutralization assays in BSL-2/2+ labs, including plate-based readouts and assay statistics.
• Hands-on experience with plaque purification and clonal characterization.
• Proficiency with IC50, MOI calculations, and assay troubleshooting.
• Strong mammalian cell culture skills (adherent and suspension), impeccable documentation, and GLP-minded data hygiene.

Preferred qualifications

• Prior experience establishing or significantly expanding BSL-2/BSL-2+ capabilities (equipment selection, SOPs, IBC/EHS alignment).
• Experience with potency assay development and implementation (fit-for-purpose; research or pre-GxP).
• Exposure to bioanalytical (bioA) method development or oversight with CRO partners (e.g., ligand-binding PK, ADA/NAb), including experimental review and data QC.
• Working knowledge of basic bioinformatics (variant calling/annotation, alignment QC) and qPCR/dPCR assays.
• Experience coordinating CRO partners and assembling concise data packages for milestones.
• Knowledge in GMP requirements and ICH guidelines

Traits for success

• Highly motivated, autonomous operator with a builder's mindset; flexible, meticulous, and eager to learn and optimize.
• Clear, concise communicator who can synthesize complex datasets and recommend next steps to senior leadership.

Tools & Environment (representative)

Class II biosafety cabinets; CO2 incubators; plate readers (luminescence/fluorescence/absorbance); centrifugation and sterile processing; imaging for plaque readouts; cold storage (-80 °C/-20 °C/4 °C); ELN/LIMS for sample and data tracking.

Title & Level:

Level open: we anticipate hiring between Associate Scientist to Scientist

Why Join Us

• Foundational role with direct impact on portfolio decisions and timelines.
• Tight collaboration with seasoned company builders.

Equal Opportunity Employer. We celebrate diversity and are committed to building an inclusive environment for all employees.

How to Apply: Please send your CV and a brief note highlighting hands-on experience with neutralization assays, serial passaging under selective pressure, plaque purification, and sequencing-based characterization.

**This RSM role covers the state of Washington, San Fran, San Jose, Fresno, Las Vegas and the surrounding areas**

Company Overview

Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help

patients reach their goals today, tomorrow, and into the future.

Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.

Position Title: Regional Sales Manager

The Regional Sales Manager (RSM) will be responsible for leading and providing strategic direction for Commercial Sales, including sales strategies, productivity, sales training and effectiveness, and ensuring achievement of performance targets and budgeted sales goals. As the leader of the Company’s field sales force, you are responsible for direct management, development, and supervision of assigned Territory Managers and their implementation of processes within local geography in accordance with approved sales and marketing resources and ensuring all sales personnel operate in an effective, efficient and compliant manner. This role reports into the National Sales Director. The RSM must live within the assigned region.

Essential Duties and Responsibilities*

•Develop and implement Regional business plans, budgets and maintain overall responsibility of action plans for the Region.

• Review performance metrics with the National Sales Director to ensure sales team is achieving maximum sales results.
• Plan and conduct meetings with the Sales Team; ensure appropriate leadership by developing and inspiring the Sales Team.
• Work closely with leadership and Market Access to maximize reimbursement from commercial & government payers.
• Create and manage Regional plans including message, reach and frequency, and budget goals. Responsible for goal- and target-setting.
• Evaluate account management performance against budget to ensure a cost-effective allocation of resources and appropriate management reporting.
• Be in the field three (3) to four (4) days working with assigned Territory Managers and complete Field Coaching Reports (FCR) with quality and in a timely manner (48-72 hours). Hold office hours on days out of the field.
• Complete all training and policy requirements on time.
• Ensure that all actions and those of his/her team both internally and through vendors
• working on our behalf, are in compliance with all laws, regulations and policies and demonstrate Company values.

*Additional duties and responsibilities as assigned

Qualifications (Education & Experience)

• Bachelor’s degree preferred. Experience in sales management in the pharmaceutical industry may be substituted.
• 8+ years of Pharmaceutical Sales experience preferred; or equivalent medical sales experience may be substituted.
• 3+ years sales management experience in a U.S. pharmaceutical or biopharmaceutical organization preferred.
• 2+ years’ experience in Cardiology (Statin, PCSK9, and NOAC) launch experience preferred.
• Proven track record of success in launching new products and/or indications and building sales teams.
• Well-developed leadership skills, and the ability to influence people at all levels inside and outside the organization.
• Demonstrated track record of successfully commercializing new products and/or expanding commercial opportunities for existing products. Sets compelling goals and is tenacious in accomplishing them. Ability to set priorities, allocate resources, take accountability, and achieve results.
• Proven ability to forge strong, diverse teams of people with multiple perspectives and talents. Have successfully created an environment in which cross-functional teams are highly motivated to accomplish goals.
• Demonstrated excellent presentation and communication skills. Proven ability to influence and work successfully with varied audiences, including customers, colleagues, scientific and technical leaders, pharmaceutical and business partners, collaborators, and senior executives.
• Excellent verbal and written English communications skills.
• Travel requirement: Up to 50% - 60% including overnight stays.

**This RSM role covers the state of Washington, San Fran, San Jose, Fresno, Las Vegas and the surrounding areas**

Company Overview

Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help

patients reach their goals today, tomorrow, and into the future.

Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.

Position Title: Regional Sales Manager

The Regional Sales Manager (RSM) will be responsible for leading and providing strategic direction for Commercial Sales, including sales strategies, productivity, sales training and effectiveness, and ensuring achievement of performance targets and budgeted sales goals. As the leader of the Company’s field sales force, you are responsible for direct management, development, and supervision of assigned Territory Managers and their implementation of processes within local geography in accordance with approved sales and marketing resources and ensuring all sales personnel operate in an effective, efficient and compliant manner. This role reports into the National Sales Director. The RSM must live within the assigned region.

Essential Duties and Responsibilities*

•Develop and implement Regional business plans, budgets and maintain overall responsibility of action plans for the Region.

• Review performance metrics with the National Sales Director to ensure sales team is achieving maximum sales results.
• Plan and conduct meetings with the Sales Team; ensure appropriate leadership by developing and inspiring the Sales Team.
• Work closely with leadership and Market Access to maximize reimbursement from commercial & government payers.
• Create and manage Regional plans including message, reach and frequency, and budget goals. Responsible for goal- and target-setting.
• Evaluate account management performance against budget to ensure a cost-effective allocation of resources and appropriate management reporting.
• Be in the field three (3) to four (4) days working with assigned Territory Managers and complete Field Coaching Reports (FCR) with quality and in a timely manner (48-72 hours). Hold office hours on days out of the field.
• Complete all training and policy requirements on time.
• Ensure that all actions and those of his/her team both internally and through vendors
• working on our behalf, are in compliance with all laws, regulations and policies and demonstrate Company values.

*Additional duties and responsibilities as assigned

Qualifications (Education & Experience)

• Bachelor’s degree preferred. Experience in sales management in the pharmaceutical industry may be substituted.
• 8+ years of Pharmaceutical Sales experience preferred; or equivalent medical sales experience may be substituted.
• 3+ years sales management experience in a U.S. pharmaceutical or biopharmaceutical organization preferred.
• 2+ years’ experience in Cardiology (Statin, PCSK9, and NOAC) launch experience preferred.
• Proven track record of success in launching new products and/or indications and building sales teams.
• Well-developed leadership skills, and the ability to influence people at all levels inside and outside the organization.
• Demonstrated track record of successfully commercializing new products and/or expanding commercial opportunities for existing products. Sets compelling goals and is tenacious in accomplishing them. Ability to set priorities, allocate resources, take accountability, and achieve results.
• Proven ability to forge strong, diverse teams of people with multiple perspectives and talents. Have successfully created an environment in which cross-functional teams are highly motivated to accomplish goals.
• Demonstrated excellent presentation and communication skills. Proven ability to influence and work successfully with varied audiences, including customers, colleagues, scientific and technical leaders, pharmaceutical and business partners, collaborators, and senior executives.
• Excellent verbal and written English communications skills.
• Travel requirement: Up to 50% - 60% including overnight stays.

Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radio antibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology, and Convergent’s proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radio antibodies precisely target cancer cells with potent, localized radiation.

In addition to the roles and responsibilities outlined below, we value team members who are eager to make an impact and grow with us professionally. We are seeking an individual who enjoys multi-tasking and has the willingness and flexibility to assume additional responsibilities as assigned.

Location: 50 Milk Street, Boston, MA

Reporting to: Caitlyn Harvey, SVP of Technical Operations

Responsibilities

• Create a strategy and lead the MSAT function through CPI, Phase 3 IND submission, PPQ and CPV (this includes API, Drug Substance, and Drug Product).
• Lead technology transfers and author technical documents including reports, standard operating procedures, master batch records, work instructions
• Collaborate with the Development Lead to learn and document the process as well as co-author development protocols and development technical reports.
• Responsible for authoring key IND updates and justifications
• Responsible for authoring MVP
• Provide onsite support at the CDMO, develop a training plan for manufacturing operators, and oversee process execution
• Lead investigations to troubleshoot process execution challenges including RCA
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

Requirements

• BS and/or MS in Chemical, Biological, or Biomedical Engineering
• 10+ yrs or equivalent combination of education and work experience
• Experience authoring IND sections
• Previous experience with antibody based drug substances and antibody-drug-conjugates
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator.
• Working knowledge of statistical design of experiments (DoE) and RCA.
• Excellent technical writing skills
• Ability to travel up to 25% of the time
• This is a Hybrid role, in office 2 to 3 days a week
• We are considering Greater Boston based candidates only

Nice to haves:

• Knowledge of radiochemistry
• Understanding of analytical methods such as HPLC, SPR, and cell based assays.
• Experience developing scale down models

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.

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