Principal Scientist, Downstream/Purification Process Development

Job Description

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 all of our company's pipeline. Our Discovery Interface team works closely with our Discovery organizations across Infectious Disease and Vaccines, Oncology, Neuroscience, and Immunology, and seeks to embed developability/manufacturability considerations into early research discussions in order to enable more seamless and rapid progression of candidates from Discovery into Process Development and Clinical Supply Manufacturing.

We are seeking an innovative, highly motivated, and broadly experienced Principal Scientist to join us at our research and development site in West Point, PA (outside Philadelphia).

The candidate will be responsible for scientific/technical leadership of a downstream/bio-purification process development team, will be a critical member of and/or leader of cross-functional program/project teams, and may also serve as the personnel manager of a small team. This role will require frequent collaboration with cross-functional teams including colleagues from Discovery, Analytical, Formulation, and Enabling Technologies. The candidate should have a strong background in recombinant protein therapeutic/vaccine design and understanding of various purification modalities, including but not limited to column chromatography (SEC, IEX, Affinity, MMC, HIC, etc.) and filtration unit operations (depth filtration, sterile filtration, viral filtration, TFF), as well as advanced knowledge in cutting edge peptide/protein handling and purification techniques. Alternatively, the candidate will have a strong background in biomolecule conjugation techniques and conjugate modalities (e.g., conjugate vaccines, antibody-drug conjugates). Preferably, the candidate will have experience with both recombinant protein purification and conjugation process development. Experience with affinity chromatography and/or live virus purification is also preferred.

Primary responsibilities may include, but are not limited to:

• Guide overall downstream/purification process design strategy, across multiple programs spanning a range of molecule types (e.g., recombinant proteins, conjugates)

• Lead early stage downstream/purification process design and development for recombinant subunit and conjugate vaccine candidates (with future potential for inclusion of live virus/vector projects in scope).

• Manage a small team of scientists as both a technical team lead and personnel manager.

• Contribute to the development of new principles, concepts, methods, and workflows to enable rapid early process development for new molecules emerging from Discovery.

• Design, execute, and analyze process development experiments to maximize understanding of recombinant subunit and/or conjugate vaccine production processes, thereby de-risking later stage process/product development.

• Represent functional area in cross-functional and strategic teams engaged in novel vaccine development, and as opportunities become available, serve as a cross-functional team lead

• Serve as the scientific/technical mentor for less experienced staff.  Provide technical guidance in the various aspects of downstream/bio-purification process development for vaccines and advanced biotechnologies.

• Generate and support strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development.

• Setting up process-analytical workstreams for analysis of downstream/bio-purification experiments through basic analytical techniques including (but not limited to) SDS-PAGE / Western blotting, UV-Vis, HPLC, Light Scattering

• Interpretation and presentation of complex data sets (including use of statistical and modeling approaches), followed by manuscript/patent preparation and submission

Education Minimum Requirement:  

• Must have a BS or MS or PhD in engineering or biological sciences

Required Experience and Skills:  

• For BS candidates, at least fourteen (14) years of experience in a pharmaceutical or biotechnology-related position.

• For MS candidates, at least fourteen (14) years of experience in a pharmaceutical or biotechnology-related position.

• For PhD candidates, at least ni