Drug Formulation Scientist

Vaccine Drug Product Development, a part of Research Laboratories in West Point, PA, is seeking a Contract Scientist or Engineer to join our department for one year. The selected candidate will work as part of a team responsible for the design and development of vaccine drug products from preclinical through Phase III with a line of sight to commercialization. The successful candidate will work hands-on in a fast-paced laboratory and collaborate closely with cross-functional teams to develop the next generation of vaccine drug products.

Primary responsibilities include the design, execution, and documentation of laboratory activities supporting formulation of novel vaccine antigens (e.g., RNA, live virus vaccines, subunit, conjugate etc.), adjuvants, and delivery systems.

Responsibilities:

• Design and perform hypothesis-driven formulation and process development experiments for sterile vaccine drug products (buffers, stabilizers, antigen/adjuvant, vials, syringes) across multiple vaccine modalities (subunit, conjugate, live-attenuated, etc.).

• Prepare formulations and fill vials/syringes for characterization & animal studies using aseptic technique and Good Laboratory Practices (GLP); support transfer to GMP manufacturing.

• Conduct stability and forced-degradation studies; analyze data, summarize findings, and author technical reports and electronic notebook entries.

• Operate and troubleshoot benchtop unit operations (mixing, filtration, pumping, lyophilization), common lab instruments (pH, scales, pipettes), and analytical tools (DLS, SLS, KF, DSC, DSF)

• Collaborate with cross-functional teams (discovery, analytical, manufacturing, regulatory) to meet project timelines and deliverables.

• Continuously learn and apply current literature, methods, and technologies to improve formulations and processes.

• Support selected analytical studies on formulated products such as osmolality, viscosity, pH, and dynamic light scattering.

• Follow safe laboratory practices and maintain the work area in a clean orderly and safe manner.

• Draft, review and execute protocols for batch manufacture.

Qualifications:

Minimum Education Requirement:

• B.S. in Chemistry, Biology, Biochemistry, Biophysics, Chemical/Biochemical engineering, Virology, or related discipline with 3-5 years of relevant experience

-or-

• M.S. in Chemistry, Biology, Biochemistry, Biophysics, Chemical/Biochemical engineering, Virology, or related discipline with 1-2 years of relevant experience

Required Skills and Experience:

• Hands-on laboratory experience (academic or industry) designing, driving, and interpreting results from experiments

• Excellent communication, writing and collaboration skills

• Excellent organizational and technical problem-solving abilities

• Comfortable working in a fast-paced environment and adapting to change

• Ability to provide critical input into experimental plans

• Team-oriented, motivated to learn, and able to manage multiple priorities under technical supervision

Desired Skills and Experience:

• Experience with analytical characterization of biotherapeutics including protein biochemistry and analytical characterization (e.g., particle size analysis and other biophysical methodologies)

• Formulation development experience with biotherapeutics including RNA, carbohydrate, protein and/or live viral vaccines as well as adjuvants for parenteral administration

• Demonstrated proficiency in aseptic technique

• Understanding of the drug product manufacturing process and scale-up considerations

• Experience with preparation and/or manufacturing of safety assessment or clinical supplies

• Experience authoring source documents used in regulatory filings

• General knowledge and/or experience with lyophilization, including techniques to examine residual moisture and the physical properties of lyophilized formulations

Preferred candidates will have experience in drug product development techniques (e.g. formulation, filtration, analytical/biochemical/biophysical characterization, and process development).