Position OverviewThe Senior Director, Biologics Drug Product Development and Manufacturing will provide program-specific leadership and subject matter expertise for biologics high-concentration formulation and pre-filled syringe (PFS) development and manufacturing in support of a best-in-class portfolio of preclinical and clinical programs. This leader will oversee the planning and execution of outsourced drug product development and manufacturing activities and will work proactively with external suppliers including CDMOs and contract labs to define project scope, mitigate risks, and ensure successful delivery with regard to technical quality, timelines and budget. The incumbent will collaborate with other functions to deliver quality drug products for preclinical studies and clinical trials and Module 3 Quality for regulatory submission and approval. The position requires strategic vision and hands-on experience managing early-stage biotech programs in a dynamic, fast-paced environment.
Responsibilities- Establishes effective CMC strategies to develop biologics formulations, including high protein concentration formulations, and pre-filled syringe manufacturing process for a portfolio of biologics products in keeping with corporate and program objectives.
- Collaborate with internal stakeholders in the areas of Analytical Development and Quality Control, Drug Substance Development, Combination Product Development, Clinical Supply Chain, Program Management, Preclinical Development, Clinical Development/Operations, Quality, Regulatory Affairs, and external business partners to push project forward.
- Creates metrics for drug product function, monitors results and implements risk management strategies to address technical challenges and meet business goals.
- Maintains an understanding of current trends and emerging biologics formulation and manufacturing technologies.
- Provides clear communication to management regarding progress against technical objectives/milestones.
- Ensures well-organized, clear and complete records of all activities across areas of responsibility.
Education & Experience- Ph.D. in (bio)chemistry, (bio)chemical engineering (or other relevant physical or life sciences discipline) or MS/BS with equivalent education or experience is required.
- A minimum of 10 years of hands-on working experience in biologics drug product development in biotech or biopharma industry.
- Experience in leading a cross functional CMC team is desired
- Experience in a fast paced, high-growth startup environment is preferred
- Experience in successful IND/IMPD/CTA submissions and approval
Skills & Attributes- Demonstrated ability in the areas of biologics high-concentration formulation and pre-filled syringe development, drug product manufacturing process development and characterization.
- Expert knowledge of analytical methods used in the characterization of formulations for biologics and experience in advancing biologics drug product manufacturing processes through clinical development to successful regulatory approval.
- Proven track record of CDMO management in supporting biologics drug product formulation, PFS development and GMP manufacturing.
- Hands-on working experience of global CMC regulatory submission and approval.
- Strategic thinker with a hands-on approach; comfortable balancing long-term planning with day-to-day execution
- Exceptional communication and relationship-building skills, with the ability to influence across levels and functions
- Strong attention to detail and problem-solving skills
- Ability to distinguish between critical and non-critical priorities
Korsana Biosciences is the sixth groundbreaking company launched by
Paragon Therapeutics, a premier biotech incubator founded by
Fairmount Funds in 2021, known for its expertise in discovering and developing cutting-edge therapeutic assets in-house.
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