Sr. Director-Purification and Viral Safety
About The Position
Bioproduct Research and Development (BRD) is seeking a Senior Director to lead the purification and viral safety CMC function for biologics products. This position is accountable for downstream process development including scale-up, viral clearance strategy, technology transfer, and regulatory submissions for a broad portfolio of bioproduct programs, including, but not limited to, monoclonal antibodies, bispecific antibodies, recombinant proteins, AAV, and bioconjugates. This leader will play an important role in setting the strategic direction for the department, ensuring platform improvements, and driving the integration of emerging technologies. The role serves as a key functional representative, collaborating with Discovery, Manufacturing, and Regulatory to advance programs from preclinical development through successful registration.
Requirements
- Ph.D in Chemistry, Biochemistry, Chemical Engineering, or related fields, with a minimum of 10 years of pharmaceutical industry experience, or BS with minimum 18 years of applicable experience
- Deep knowledge of bioproduct development from candidate selection through regulatory submission
- Excellent communication, interpersonal, and strong leadership skills are essential.
- Demonstrated experience leading high-performance scientific teams
Nice To Haves
- Strong track record of technology innovation in downstream bioprocessing or viral safety
- Demonstrated experience across end-to-end biologics CMC workflows, with broad knowledge of upstream, analytical, and formulation functions and hands-on regulatory filing experience for early- and late-stage programs.
- Experience collaborating with Manufacturing on GMP implementation, including technology transfer and facility fit.
- Proven ability to collaborate with partners to ensure effective oversight across the entire bioproduct portfolio.
- Experience leveraging AI tools to improve efficiency in CMC workflows.
Responsibilities
- Leads the purification development and viral safety department to enable development, scale-up, and technology transfer for both early- and late-stage bioproduct portfolios.
- Establishes and drives the strategic direction of the department, ensuring strong execution to support portfolio growth and meet organizational objectives.
- Provides oversight to ensure the department stays current with emerging technologies, capabilities, and evolving regulatory initiatives, and leads their effective implementation.
- Defines and drives innovation strategy and roadmap to ensure competitiveness and alignment with Discovery and manufacturing needs.
- Proactively reallocates resources to respond to changing portfolio demands, including program acceleration, while driving productivity through operational excellence.
- Leads the adoption and integration of AI/ML tools, process modeling, and high-throughput screening to advance purification and viral safety workflows.
- Develops talent at all levels and ensures effective coaching and performance management.
- Oversees development laboratory operations, including the scale-up facility, with a strong focus on workplace safety.
- Collaborates closely with leaders across departments to ensure overall business effectiveness.
Benefits
- company bonus (depending, in part, on company and individual performance)
- company-sponsored 401(k)
- pension
- vacation benefits
- medical benefits
- dental benefits
- vision benefits
- prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance
- death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
