Director, Large Scale Drug Substance Manufacturing

Location
Redwood City, CA, United States
Posted
Sep 12, 2020
Ref
1979417617
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
The Director, Large Scale Drug Substance 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.

Responsibilities:

· 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 commercial batches

· 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 spend

· Provide person-in-plant (PIP) support for critical manufacturing operations as per requirement

· Travel domestically and internationally up to 10% of the time

Qualifications:

· 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 leading teams

· Extensive experience in Large Scale manufacturing (larger than 10kl bioreactor) of biologics using CHO cells in cGMP setting.Experience in both Upstream and Downstream manufacturing.

· 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 required.

· 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 standards.

· Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams.

· Ability to travel at least 10% of the time.

The salary is competitive and commensurate with experience and qualifications.

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.