An Equal Opportunity Employer, Allakos values and encourages
diversity in the workplace Position: Associate
Director/Director, Large Scale DS Manufacturing
Location: Redwood City, CA
Job Id: 179-1068
# of Openings: 1
Associate Director / Director, Large Scale DS 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 an Associate Director /
Director, Large Scale DS Manufacturing to join our expanding team.
The scope of the position and requirements are described below.
The Associate Director / Director, Large Scale DS Manufacturing
would be key member of DS supply team and would be responsible for
all activities related to Large Scale manufacturing (up to 20kl) of
our late stage clinical biologics (Mab) molecule AK002. This
position would be responsible for the tech transfer, supervision of
engineering and Clinical batches, BLA enabling activities, PPQ
Batches and commercial production at multiple CMO sites.
· Lead the facility fit and technology transfer of AK002 process
to multiple large scale CMO sites
· Supervise the Engineering and Clinical batches at the CMOs,
Review and approve Batch records, Bill of Materials, Bill of
Parameters, deviations and CAPA documents for these batches
· Plan the process characterization and other BLA enabling
studies including small scale and at scale studies. Coordinate the
execution of small-scale studies with the in-house Process
Development team and the at scale studies with the CMOs
· Plan and supervise PPQ batches at CMOs. Review and approve
protocols and reports for PPQ batches
· Author and review for the BLA submission documents
· Supervise commercial production post PPQ completion. Review
and approve change controls, deviation and CAPAs associated with
· Lead cross functional meetings with Quality, Regulatory,
Supply Chain, Process Development, Analytical and Drug Product to
build consensus on key issues and facilitate decision making to
move the project forward
· Provide strategic plan for DS supply to management
· Review Quality and Supply agreement with the CMOs
· Support the site manager in forecasting and budgeting of CMO
· Provide person-in-plant (PIP) support for critical
manufacturing operations as per requirement
· Travel domestically and internationally up to 10% of the
· At least 15 years of relevant experience (12+ with MS, 10+ for
PhD) successfully working in biopharmaceutical industry with proven
track record of leadership and success
· At least 8 years managing cross functional projects and
· Extensive experience in Large Scale manufacturing (larger than
10kl bioreactor) of biologics using CHO cells in cGMP
setting.Experience in both Upstream and Downstream
· Experience in facility fit, technology transfer of both USP
and DSP process.
· Should have worked with late stage and commercial biologics
with experience in process characterization, PPQ batches and other
BLA enabling studies and CPV programs.
· Experience working with Contract Manufacturers is
· Preferably experienced in BLA submission write ups.
· Experience in people and stake holder management, conflict
resolution and building consensus.
· Previously worked with cGMP-regulated environment including
relevant US/EU regulatory and quality requirements, practices and
· Exceptional interpersonal skills to establish positive
relationships with internal stakeholders, CROs/CMOs, and
· Ability to travel at least 10% of the time.
The salary is competitive and commensurate with experience and
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.