About the position
We are seeking an esteemed scientific leader in the process development and manufacturing of vaccine drug substances for the role of Distinguished Scientist (equivalent to the Executive Director level), in the Vaccines & Advanced Biotechnologies Process R&D (VAX PR&D) department, located in West Point, PA. Our department is responsible for the process development and clinical manufacturing of drug substances (DS) and adjuvant bulk for the entire vaccine pipeline at our company, spanning from preclinical to commercialization stages. We work on developing and commercializing life-saving vaccines from diverse modalities: polysaccharides, RNA, protein subunits, polysaccharide conjugates, viral vectors, VLPs, etc. We are part of the Process R&D organization, which enables modality-agnostic DS process development and clinical manufacturing for all of our company's pipeline. Elevate your career and make a lasting impact in the field of vaccine development! We are on the lookout for a Distinguished Scientist to lead our VAX PR&D team in downstream (DS) process development and manufacturing. In this influential role, you will be at the forefront of our scientific endeavors, responsible for crafting and implementing a visionary scientific strategy that encompasses the entire lifecycle of vaccine DS development, including the creation of a forward-thinking technology roadmap.
Responsibilities
- Crafting and implementing a visionary scientific strategy that encompasses the entire lifecycle of vaccine DS development.
- Fostering strategic partnerships across CMC areas and collaborating with Discovery, Clinical, Commercial Manufacturing, and Marketing teams.
- Building and expanding our external collaboration network with leading academic institutions, industry partners, and NGOs.
- Enhancing our scientific visibility through high-impact publications and keynote presentations at major conferences.
- Inspiring and nurturing the next generation of scientific talent through mentorship and coaching.
- Advising and supporting the DS development teams as they navigate critical milestones and tackle complex technical challenges.
Requirements
- PhD in Chemical Engineering, Biochemistry, pharmaceutical sciences, or a relevant field.
- A minimum of 15 years of experience in Drug Substance (DS) process development for vaccines/biologics.
- Extensive DS experience in upstream, downstream, and analytical development for vaccines/biologics.
- Proficient with major cell substrates (E.coli, yeasts, HEK293, Vero, CHO, etc) and modalities (LVV, viral vectors, RNA, protein subunits, conjugates, etc).
- Experience in CMC or program leadership leading to multiple successful regulatory submissions for vaccines/biologics.
- Excellent understanding of modelling, automation, AI/ML, and Systems Biology.
- Extensive knowledge of global regulatory requirements for vaccines.
- Demonstrated scientific and communication capability to strongly influence senior leaders across functional areas.
Nice-to-haves
- Recognized as a scientific leader nationally/internationally for expertise in vaccines/biologics process development.
- Proven record of pushing the boundary of the vaccine/biologics field.
- Working knowledge on adjuvant development and innovation as well as associated drug product development.
- Demonstrated expertise in addressing complex challenges in pipeline and life cycle management.
- Consistently delivers breakthrough results aligned with business needs.
Benefits
- Join a passionate team dedicated to pushing the boundaries of science and making a difference in global health.
- Engage in transformative research that has the potential to save lives and improve health outcomes worldwide.
- Benefit from a culture that prioritizes professional development, collaboration, and work-life balance.
