Associate Principal Scientist, Preclinical Dev. Full-time

Associate Principal Scientist, Vaccine And Advanced Biotechnologies (Vax) Process R&D

Applications are sought for an opportunity in the Vaccine and Advanced Biotechnologies (VAX) Process R&D department, which is part of our Company's Research Labs division. The individual will support our Company's downstream process development efforts for Vaccine programs at West Point, PA.

Vaccines and Advanced Biotechnologies (VAX) Process R&D is responsible for the development and clinical manufacturing of Drug Substance (DS) and Drug Product Intermediates (DPI) for the vaccine and advanced therapy pipeline, spanning from preclinical to commercialization stages. We are part of the Process R&D organization, which enables modality-agnostic DS/DPI process development and clinical manufacturing for our company's pipeline. Our vaccines downstream process development team develops safe, scalable, robust, cost-effective downstream processes that enable clinical and commercial manufacture of vaccines and adjuvants across all vaccine modalities.

We are seeking an innovative, highly motivated, and experienced Associate Principal Scientist to join us at our research and development site in West Point, PA. The candidate will be responsible for scientific/technical leadership of a bioconjugation process development team, and will also be a critical member of cross-functional program/project teams.

This role will require frequent collaboration with cross-functional teams including Analytical, Formulation, Process Chemistry, Enabling Technologies, and Manufacturing colleagues. The candidate should have a strong background in downstream bioprocess/bioconjugation design, including reaction steps, filtration (tangential and normal flow) and column chromatography. Preferably, the candidate will have a strong background in biomolecule conjugation techniques and conjugate modalities (e.g., conjugate vaccines, antibody-drug conjugates).

Primary responsibilities include, but are not limited to:

• Lead downstream process design and development for conjugate vaccine candidates.
• Design, execute, and analyze process development experiments to maximize conjugate vaccine production processes, thereby de-risking later stage development and tech transfer.
• Represent functional area in cross-functional and strategic teams engaged in vaccine development.
• Lead tech transfer of vaccine bioconjugation processes for clinical and commercial manufacture.
• Serve as scientific/technical mentor for junior staff, providing technical guidance in the various aspects of downstream bioprocess/bioconjugation development.
• Support strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development.
• Analysis of experiments through analytical techniques including HPLC, light scattering, and spectroscopy.
• Data interpretation and presentation, manuscript/patent preparation.

Education Minimum Requirement:

• BS, MS or PhD in engineering or bio/chemical sciences: Chemical Engineering, Bioengineering, Biomedical Engineering, Chemistry, Biochemistry, Molecular Biology, Biotechnology
• For BS candidates, at least eight (8) years of experience in a pharmaceutical or biotechnology-related position
• For MS candidates, at least five (5) years of experience in a pharmaceutical or biotechnology-related position
• For PhD candidates, at least three (3) years of experience in a pharmaceutical or biotechnology-related position

Required Experience and Skills:

• Strong scientific and hands-on understanding of downstream bioprocess/bioconjugation unit operations, biotherapeutic and/or vaccine process development and sound understanding of scale-up principles.
• At least five (5) years of hands-on laboratory experience in downstream bioprocess/bioconjugation development.
• Prior experience with statistical design of experiments (DOE) and/or algorithmic process optimization.
• Strong understanding of, or hands-on experience in, cGMP manufacturing.
• Ability to work effectively both independently and in a team-focused environment.
• Well-developed organizational, record-keeping, and timeline/resource-mapping skills.

Preferred Experience and Skills:

• Experience with biomolecule conjugation (e.g., conjugate vaccines, antibody-drug conjugates), conjugation chemistry and downstream bioconjugate processing.
• Experience in leading technical development teams and mentoring others.
• Experience in authoring and reviewing CMC regulatory documentation.
• Experience with process and technology transfer.

The successful candidate will be expected to demonstrate the ability to communicate results of his/her work in both verbal and written formats. They are also expected to demonstrate flexibility in responding to changing priorities or dealing with unexpected events. In addition to the core responsibilities outlined above, the candidate will be expected to comply with all required training and maintain a focused attention on laboratory safety for him/herself and his/her team.

Position may require working with infectious agents, pathogens, and/or potent compounds with appropriate engineering controls and PPE. Some travel or off-hours work may be required.