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Sr. Director, Biologics Drug Substance Development and Manufacturing
2 months ago
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy.
We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation
Position Summary:
The Sr. Director, Biologics Drug Substance Development and Manufacturing, will provide technical leadership and subject matter expertise for drug substance process development, tech transfer, scale-up, manufacturing, control strategy development, implementation and process validation. In accordance with Zenas’ outsourcing model for drug development, the incumbent will oversee the planning and execution of outsourced drug substance activities and work proactively with external partners to define project scope, mitigate risks, and ensure successful delivery with regard to technical quality, timelines and budget. S/he will contribute to building/maintaining excellent working relationships with CDMOs and their respective technical staff and management. Works within a cross-functional team environment to support Zenas’ senior leadership team in defining and executing against short-, intermediate- and long-term strategic goals.
Key Responsibilities:
- Provides technical leadership, management, and oversight for:
- Development, technology transfer, scale-up and manufacture of biologics drug substance to support nonclinical and clinical studies.
- Control strategy development, implementation and process validation of biologics drug substance to support product commercialization.
- FMEA and proactive management of process risks and resolution of technical challenges. Development and execution of contingency plans, as necessary.
- An accurate schedule/project plan of assigned timelines and deliverables and delivery according to the plan.
- In partnership with QA, ensures the implementation of cGMP compliant processes, and supports deviation investigations and associated CAPAs for cGMP manufacturing and drug substance release.
- Prepares CMC documentation for regulatory filings, responses to health authority questions and supports regulatory agency interactions.
- Pro-actively collaborates with internal stakeholders and external business partners to achieve group, departmental and corporate goals. Supports business partner obligations.
- Establishes and maintains an understanding of current trends and emerging manufacturing technologies.
- Applies innovative technical ability and knowledge to critically analyze data and results.
- Sets clearly defined goals/objectives to ensure delivery of high-quality results in keeping with approved timelines and budgets.
- 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.
Qualifications:
- Ph.D. in (bio)chemistry, (bio)chemical engineering (or other relevant physical or life sciences discipline) or MS with equivalent education or experience is required.
- 15+ years of experience in biologics drug development or manufacturing in biotech or biopharma industry, with significant hands-on experience in areas of downstream process development and tech transfer, BLA enabling study and PPQ, commercial manufacturing, commercial supply, and product life cycle management.
- In-depth understanding of biological purification and separation fundamentals.
- Hands-on working experience of CMC regulatory submissions from IND filing to BLA submission and approval.
- Demonstrated track record of CDMO management in supporting technology transfer, GMP manufacturing, PPQ and process validation.
- Effective self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.
- Demonstrated ability to work efficiently across multiple project teams and business functions.
- Ability to work non-traditional work hours when needed, given international operations across time zones.
- Ability to do domestic and international travel [up to 20%].
