Distinguished Scientist, Vaccines & Advanced Biotechnologies Process R&D

MSD • Upper Gwynedd Township, PA

5d • Onsite

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 modalities: polysaccharides, protein subunits, polysaccharide conjugates, viral vectors, RNA, VLPs, etc. We are part of the Discovery Sciences Clinical Supply organization, which enables CMC development and clinical manufacturing for all 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 and clinical manufacturing, including the creation of a forward-thinking technology roadmap.
Fostering strategic partnerships across CMC areas and collaborating with Discovery, Clinical, Commercial Manufacturing, and Marketing teams to drive innovation and accelerate the commercialization of our vaccine pipeline.
Building and expanding our external collaboration network with leading academic institutions, industry partners, and NGOs, while 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, cultivating a culture of excellence and creativity within our organization.
Advising and supporting the DS development teams as they navigate critical milestones and tackle complex technical challenges, ensuring the successful advancement of our projects.
In this role, you will report directly to the head of VAX PR&D and play a key role on our Leadership Team. You will also represent our organization in various capacities, including due diligence, regulatory input, and program leadership.

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, with exposure to all stages and aspects of the product life cycle.
• Extensive DS experience in upstream, downstream, and analytical development for vaccines/biologics (with in-depth domain knowledge), as well as working knowledge of drug product development and clinical manufacturing.
• 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 modeling, 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 and steer scientific strategy and policy.
• Proven record of coaching talents and building high performance teams.

Nice To Haves

• Recognized as a scientific leader nationally/internationally for expertise in vaccines/ biologics process development. Examples of which could be a proven track record of successful collaboration with industry and academia, recognition of work via professional bodies, demonstration of research impact via awards and nominations.
• Proven record of pushing the boundary of the vaccine/biologics field, with practical implementation in process development and manufacturing to advance pipeline.
• 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 through critical thinking, innovation, scientific rigor, and cross-functional collaboration.
• Consistently delivers breakthrough results aligned with business needs and advancing the field.
• Demonstrated ability to apply and promote an innovation and growth mindset within teams and partnerships.
• Demonstrated capability and organizational intelligence to lead changes under complexed and ambiguous situations.

Responsibilities

• Crafting and implementing a visionary scientific strategy that encompasses the entire lifecycle of vaccine DS development and clinical manufacturing, including the creation of a forward-thinking technology roadmap.
• Fostering strategic partnerships across CMC areas and collaborating with Discovery, Clinical, Commercial Manufacturing, and Marketing teams to drive innovation and accelerate the commercialization of our vaccine pipeline.
• Building and expanding our external collaboration network with leading academic institutions, industry partners, and NGOs, while 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, cultivating a culture of excellence and creativity within our organization.
• Advising and supporting the DS development teams as they navigate critical milestones and tackle complex technical challenges, ensuring the successful advancement of our projects.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree