Drug Product Formulation Scientist

Job Description

Position Overview:

Our Eurofins PSS team is seeking a Drug Product and Formulation Scientist to work onsite supporting our client's Drug Product and Formulations development activities for lentiviral vector (LVV)-based gene therapy products.  The successful candidate will help design and execute bench-scale experiments and contribute to technical documentation for drug product development.  This role will parter closely with process development, analytical development, and technical operations teams, operating with moderate supervision while building toward independent ownership of formulation and drug product workstreams. This is an excellent opportunity for a motivated scientist to build formulation expertise on a novel gene therapy program.

Responsibilities:

• Support formulation and drug product development activities by executing studies to:
  • Optimize formulation buffer via buffer/excipient screening, using accelerated stress and long-term storage stability studies to assess and improve conditions that support vector stability.
  • Develop and optimize product filtration methods (e.g. sterile filtration compatibility, membrane selection, filter fouling/throughput studies), evaluating impact on vector recovery.
  • Enable and optimize GMP-compliant drug product manufacturing workflows, completing studies related to (but not limited to) scale-up, in-process hold times, fill/finish, and container closure evaluation.
  • Evaluate in-use compatibility (e.g., shelf-life, clinical formulation, and infusion set hold time studies) supporting clinical administration of the drug product.
• Perform biophysical characterization of the vector (e.g., particle analysis via HIAC) and support development and optimization efforts for new characterization methods (e.g. FlowCam or NanoFCM) as needed.
• Support the technology transfer efforts by preparing documentation, data packages, and coordination of materials for internal teams or CDMO partners
• Maintain accurate, compliant lab notebooks, data records, and sample tracking in a GLP environment.
• Draft protocols, study summaries, and technical reports, with guidance and review from senior team members.
• Contribute to regulatory filings (e.g. CMC sections of IND/CTA) as needed.
• Present data at technical forums.

Qualifications

Basic Minimum Qualifications:

• B.S. in Pharmaceutical Science, Chemical Engineering, Chemistry, Biology, Biochemistry or a related field with at least 3 years of relevant industry experience OR M.S. in Pharmaceutical Science, Chemical Engineering, Chemistry, Biology, Biochemistry or a related field with at least 1 years of relevant industry experience.
• Experience with formulation stability studies and/or drug product filtration process development (e.g. buffer preparation and optimization, sterile filtration, scale-up, and post-formulation particle sizing and characterization methods).
• Experience supporting technology transfer of GMP-ready formulation methods to manufacturing labs.  
• Strong problem-solving skills and willingness to take initiative within defined scope.
• Ability to design experiments, troubleshoot and interpret experimental results, and present conclusions.
• Ability to work independently with minimal supervision after initial training.
• Ability to set priorities and multi-task activities to effectively manage workflows and drive deliverables to completion.
• Significant attention to detail and accuracy in following, executing, and documenting experimental protocols and results in electronic notebooks.
• Strong team orientation, with excellent organizational skills, self-motivation, and a positive attitude.
• Strong communication skills, with the ability to clearly communicate experimental results and observations.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Preferred Qualifications:

• Experience with lentiviral or other viral vector platforms (e.g., LVV, AVV, adenovirus).
• Experience with analytical testing methods relevant to viral vectors (e.g. qPCR/ddPCR titer, potency assays, particle characterization methods).
• Experience working in or exposure to GMP environment.

Additional Information

This role is a full-time, permanent position Monday-Friday 8am-5pm. Candidates currently located within commutable distance to Boston, MA are encouraged to apply.

Excellent full-time benefits include:

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for yearly goal-based bonus & merit-based increases
• Compensation: $32.00-$41.00 per hour based on education and relatable industry experience.

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Compensation: 32 to 41 (USD) (HOURLY)