Director, Vaccine Process Development

Job Description

Our company, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.  Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.  To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

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

Under the direction of the Senior Director, this role will lead bulk process development efforts for protein subunit or conjugate based vaccine candidates or vaccine adjuvant candidates. The successful candidate will serve as the technical lead and people manager for a group of upstream and downstream scientists and engineers whose deliverables include the development of robust, efficient, scalable processes for protein subunit or conjugate vaccine or adjuvant 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), discovery, and commercialization (BDSC).

Primary responsibilities include, but are not limited to:

• Technical lead and direct or indirect people manager of a team (10-20 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 protein subunit, conjugate, or adjuvant production 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 his/her team.

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 fourteen (14) years of experience in biotechnology related position

• For MS, at least twelve (12)