Drug Product Formulation Scientist
About The Position
Eurofins Professional Scientific Services is seeking a Drug Product and Formulation Scientist to work onsite and support a client’s drug product and formulations development activities for lentiviral vector (LVV)-based gene therapy products. The scientist will design and execute bench-scale experiments and contribute to technical documentation for drug product development, working closely with process development, analytical development, and technical operations teams. The role operates with moderate supervision while developing toward independent ownership of formulation and drug product workstreams. The position supports formulation development, filtration and manufacturing workflow optimization, product characterization, technology transfer, and preparation of technical and regulatory documentation. Work is conducted in a GLP environment and includes maintaining accurate laboratory records and presenting experimental data. This is a full-time, permanent role, Monday through Friday, 8:00 a.m. to 5:00 p.m., based onsite. Candidates within commuting distance of Boston, Massachusetts are encouraged to apply.
Requirements
- Bachelor’s degree in Pharmaceutical Science, Chemical Engineering, Chemistry, Biology, Biochemistry, or a related field and at least 3 years of relevant industry experience, or a master’s degree in one of these fields and at least 1 year of relevant industry experience.
- Experience with formulation stability studies and/or drug product filtration process development, such as 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 laboratories.
- Strong problem-solving skills and willingness to take initiative within a defined scope.
- Ability to design experiments, troubleshoot, interpret experimental results, and present conclusions.
- Ability to work independently with minimal supervision after initial training.
- Ability to set priorities and multitask to manage workflows and complete deliverables.
- Strong attention to detail and accuracy when following, executing, and documenting experimental protocols and results in electronic notebooks.
- Strong team orientation, organizational skills, self-motivation, and a positive attitude.
- Strong communication skills and ability to clearly communicate experimental results and observations.
- Authorization to work indefinitely in the United States without restriction or sponsorship.
Nice To Haves
- Experience with lentiviral or other viral vector platforms, such as LVV, AAV, or adenovirus.
- Experience with analytical testing methods relevant to viral vectors, such as qPCR/ddPCR titer, potency assays, or particle characterization methods.
- Experience working in or exposure to a GMP environment.
Responsibilities
- Support formulation and drug product development by optimizing formulation buffers through buffer and excipient screening, accelerated stress studies, and long-term storage stability studies.
- Develop and optimize product filtration methods, including sterile filtration compatibility, membrane selection, filter fouling, and throughput studies, and evaluate effects on vector recovery.
- Enable and optimize GMP-compliant drug product manufacturing workflows through studies involving scale-up, in-process hold times, fill/finish, and container closure evaluation.
- Evaluate in-use compatibility, including shelf-life, clinical formulation, and infusion set hold-time studies.
- Perform biophysical characterization of the vector, including particle analysis via HIAC, and support development and optimization of characterization methods such as FlowCam or NanoFCM.
- Support technology transfer by preparing documentation and data packages and coordinating materials for internal teams or CDMO partners.
- Maintain accurate, compliant laboratory 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, including CMC sections of IND/CTA, as needed.
- Present data at technical forums.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
