Position OverviewThe Senior Director, Biologics Drug Substance Development and Manufacturing, will provide program-specific leadership and subject matter expertise for drug substance development and manufacturing activities in support of a best-in-class portfolio of preclinical and clinical programs. This leader will oversee the planning and execution of outsourced drug substance 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 in relation to technical quality, timelines and budget. The incumbent will collaborate with other functions to deliver quality 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 for biologics drug substance manufacturing process development, optimization, characterization, scale-up, GMP manufacturing for a portfolio of biologics in keeping with corporate and program objectives.
- Collaborates with internal stakeholders in the areas of Drug Product Development, Combination Product Development, Analytical Development and Quality Control, 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 substance function, monitors results and implements risk management strategies to address technical challenges and meet business goals.
- In partnership with QA, supports deviation and OOS investigations, and associated CAPAs for drug substance release and stability testing.
- Prepares CMC documentation for regulatory and/or patent filings.
- Leads CDMO/CRO selection, contract negotiation, and budget/scope management related to drug substance development and manufacturing.
- Maintains an understanding of current trends and emerging biologics drug substance 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 12 years of hands-on working experience in biologics drug substance development in biotech or biopharma industry.
- Experience in a fast paced, high-growth startup environment is preferred
- Experience in successful IND/IMPD
Skills & Attributes- Demonstrated ability in the areas of leading and managing biologics drug substance manufacturing process development, optimization, characterization, scale-up, and GMP manufacturing in an outsourced business model.
- Proven track record of CDMO selection and management in supporting biologics drug substance 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
The anticipated base salary range for this position is $250,000 - $280,000. This role may also be eligible for a target annual bonus and equity-based compensation, as well as participation in the company's benefit programs. Actual compensation will depend on several factors, which may include, but are not limited to relevant years of experience, educational background, and geography.
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