Associate Director, Drug Substance Contract Mfg Site Manager - Job #10
Company: Allakos, Inc.
Location: Redwood City
Posted on: February 16, 2020
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. Responsibilities
- Accountable for the overall performance of our drug substance
- 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
- Drug substance CMO partner for company within the CMC Supply
- 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
- 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
- Point person to manage the Allakos / CMO relationship including
negotiation of improvement plans to address performance or
- 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
- US/EU regulatory and quality requirements, practices, and
- 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 and reference Job#1023Allakos 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.
- Working at Allakos
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Keywords: Allakos, Inc., San Francisco , Associate Director, Drug Substance Contract Mfg Site Manager - Job #10, Executive , Redwood City, California
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