Sr. Director of Biologics Development and Manufacturing
Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases. The company is seeking to recruit a Senior Director, Biologics Development and Manufacturing.
The Sr. Director of Biologics Development and Manufacturing is accountable for and leads all aspects of biologics development, clinical manufacturing, and commercialization. The ideal candidate is also responsible for manufacture of pre-clinical material for animal testing. The candidate coordinates development activities working closely with the CMC project team to ensure timely delivery of material and information.
The primary responsibility of this position is to set strategic direction and provide senior-level oversight for the cell banking, cell culture, purification, formulations, and drug product fill/finish to support all stages of development. This leadership position is directly responsible for the improvement of the scientific oversight of the manufacturing processes, scale up, and technology transfer activities. This position reports to the Vice President, Technical Operations.
- Provide leadership and direction to the Biologics Development and Manufacturing team through establishment of goals, plans and performance metrics that are periodically reviewed & reported to the Head of Technical Operations.
- Maintain effective strategic working relationships with CMO partners and be the senior development expert for managing the production of clinical/commercial drug substance and drug product.
- Supports strategic planning by identifying development scenarios, risks and options, collaborating with Research, Quality Assurance, Regulatory, Program Management, Clinical Operations, Legal, and Commercial.
- Identify risks and assumptions in plans, anticipates problems and plans for contingencies. Removes obstacles to move work forward and/or to get efforts back on track.
- Oversee the successful development and transfer of robust processes (upstream, downstream, fill/finish) that meet or exceed the programs’ target product profiles and other key objectives (e.g., yield, COGs, impurity profiles)
- Approve technical reports and review relevant CMC sections for regulatory submissions and other HA interactions.
- Prepare annual operational and capital budgets including staffing, equipment, reagents and supplies and costs associated with process development and contract manufacturing.
- Help cultivate highly productive and results-driven teams through leading by example and displaying a can-do attitude.
- Effectively & efficiently communicate results internally and externally. Prepare data reports for internal use, regulatory filings, and scientific conferences.
- Provide scientific and technical expertise in the design, qualification, and validation of manufacturing operations in order to meet global standards of quality and regulatory compliance.
- BS/MS/Ph.D. in life science or engineering and at least 20/17/15 years of related experiences in the biotechnology or pharma industry
- Energetic, flexible, collaborative, and proactive leadership and management skills to grow and develop the Biologics Development and Manufacturing team of scientific and engineering professionals
- Proven ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stakeholders
- Strong planning and tracking skills, able to see big picture, well-organized, focused on results, capable of managing multiple projects, excellent time management with respect to priorities and self-management
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills
- Able to work in a fast-paced and dynamic environment with competing priorities and prioritize driving projects forward and meeting program/project deliverables
- Proven ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stakeholders.
- Proven experience with regulatory submissions (IND, BLA, MMA, etc.), ideally for products which were ultimately approved for commercial distribution.
- Position may require occasional evening and/or weekend commitment
- Position may require occasional travel (up to 10%), domestic and international
The salary is competitive and commensurate with experience and qualifications.
Interested applicants please send resume to CMCcareers@allakos.com
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.