Director, Vaccine & Advanced Biotechnologies

Job Description

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

Under the direction of the Sr. Director, this role will lead upstream and/or downstream process development efforts for recombinant sub-unit and/or microbial-based vaccine candidates. The successful candidate will serve as the technical lead and people manager for a group of upstream and/or downstream scientists and engineers whose deliverables include the development of robust, efficient, scalable processes for recombinant sub-unit and/or microbial-based vaccine production. These responsibilities also include the manufacture of cGMP clinical bulks and tech transfer to clinical or commercial manufacturing facilities.  Duties may include pre-clinical and clinical process development, process scale-up and engineering, PAT implementation, development of innovative process monitoring and/or process control strategies, cGMP document preparation and modifications, and technology transfer to manufacturing. The successful candidate will also be responsible for representing VAX PR&D as a bioprocess expert in internal, cross-functional project teams and external conferences/consortia. This role will closely collaborate with the other Directors within VAX PR&D as well as with partner groups within analytical development (AR&D), drug product development (VDPD), enabling technologies (ET), and commercialization (BDSC).

Primary responsibilities include, but are not limited to:

• Technical lead and people manager of a team (~10-15 scientists)

• Develop program strategies and guides future technological investment activities based on regulatory and industry trends.

• Advance a culture of scientific excellence, by serving as a subject matter expert (SME) in the areas of process development, characterization, and technology transfer.

• Drive the development of new principles, concepts, and methods to enable accelerated process development, process scale-up, and technology transfer to meet program deliverables.

• Support/lead strategic initiatives and drive innovation in vaccine and advanced biotechnology process development.

• Represent functional area in cross-functional and strategic teams engaged in in novel vaccine and advanced biotechnology development. 

• Actively network with both internal and external counterparts (i.e. biopharma industry, academia).

• Engage with the VAX PR&D leadership team and multidisciplinary DSCS teams to advance departmental strategic and cultural initiatives.

• Identify, recruit, onboard, and develop employees within the VAX PR&D organization.

• Provide mentorship, technical oversight and strategic guidance to direct reports.

• Perform proactive resourcing planning and establish viable succession plans for key positions.

• Ensure cGMP compliance and operational excellence in the laboratories.

• Author/review required regulatory and technical documentation.

• Handle multiple priorities and balance work to achieve business goals.

The successful candidate will be 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 maintain focused attention on compliance training and laboratory safety for team.

Position may require employee to be willing to work with infectious agents, pathogens, and/or potent compounds.  Travel may be required.

Education Minimum Requirement:

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

Required Experience and Skills:

• For BS, at least twelve (12) years of experience in biotechnology related position

• For MS, at least ten (10) years of experience in biotechnology related position

• For PhD, at least eight (8) years of experience in biotechnology related position

• Must have strong scientific understanding of process development principles.

• Excellent scientific understanding of a variety of upstream and/or downstream techniques

• At least 4 years of hands-on experience in protein sub-unit and/or microbial-derived product process development.

• Prior experience of statistical design of experiments

• Strong understanding and experience in