Associate Director, Drug Substance Contract Mfg Site Manager – Job #1023
As a member of the CMC Supply Operations Management team within Technical Operations at Allakos, this person will be accountable for overseeing all activities in the company's drug substance (DS) contract manufacturing network. Will lead cross-functional teams and support the processes and systems to ensure exceptional quality and reliability throughout the external drug substance manufacturing network. This includes developing a CMO strategy, managing the business relationship, ensuring the successful supply of product and achieving operational and business goals. He/She will lead DS product changes, investigations, process improvement and risk mitigations. This position reports to the Exec. Director of CMC Supply Operations.
- Accountable for the overall performance of our drug substance CMOs
- Provide leadership, management, and instruction to external manufacturing sites to ensure the company's clinical / commercial supply and operational / project goals are met promptly and exceptionally.
- Drug substance CMO partner for company within the CMC Supply Operations group.
- Responsible for organizing and leading the company's cross-functional teams which work with the CMOs including Quality, Regulatory, Finance, Technical Operations, Legal, Clinical, Commercial and Business Development.
- Facilitates the identification, prioritization, planning and execution of a broad range of medium to complex technical projects. Ensures successful and timely completion of deliverables. Owns planning and execution of technical changes that have regulatory and/or multi-site impact.
- Develops and maintains project plans for key DS related deliverables. Leads risk identification and mitigation activities. Proactively identifies and tracks issues and drives their resolution.
- Ensures the CMO executes the production plan to deliver an uninterrupted supply of clinical and commercial product. Identifies supply constraints and leads timely resolution of issues. Monitors production campaigns and reports on CMO’s performance against plans.
- Point person to manage the Allakos / CMO relationship including negotiation of improvement plans to address performance or contractual issues.
- Ensures CMO project plans are aligned with overall Allakos plans for regulatory filings and other key initiatives.
- Ensures that corporate safety, health and environment (SHE) and Quality audits are performed, and mitigations plans are in place for the CMO to comply with terms of agreements, corporate group policy and local legal requirements.
- Reviews commercial supply and quality agreements. Forecasts CMO budget and gains approval. Controls cost to ensure the CMO Site is within approval budget.
- Travel domestically and internationally up to 15% of the time.
- At least 15 years of experience (12+ with MS, 10+ for PhD) successfully working in an operations environment, with at least 8 years managing cross functional projects.
- Experience working with Contract Manufacturers is required with overall knowledge of biologics Drug Substance commercial manufacturing in a cGMP regulated environment. Monoclonal Antibody Experience highly desired.
- Previous experience in technology, quality and/or supply chain roles is preferred.
- Certification in Project Management (i.e. PMI certification) or additional relevant management training is preferred.
- Previously worked with cGMP-regulated environment including relevant
- US/EU regulatory and quality requirements, practices, and standards.
- Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams.
The salary is competitive and commensurate with experience and qualifications. Interested applicants please send resume to CMCcareers@allakos.com and reference Job#1023
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.