Associate Director, External Drug Substance Manufacturing
Associate Director, External Drug Substance ManufacturingAllakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Position Summary:The Associate Director, External DS Manufacturing (small scale) would be key member of DS supply team and would be responsible for all activities related to 2000L scale manufacturing 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 two CMO sites.
- Supervise the PPQ and commercial 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 relevant BLA submission documents.
- Supervise commercial production post PPQ complétion. 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.
- Review Quality and Supply agreements 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.
Qualifications and Expertise:
- At least 15 years of relevant experience (10+ with MS, 8+ for PhD) successfully working in biopharmaceutical industry with proven track record of leadership and success.
- At least 5 years managing cross functional projects and leading teams.
- Extensive experience in manufacturing of biologics using CHO cells in cGMP setting. Experience in both Upstream and Downstream manufacturing. Previous roles in MSAT/process validation function is preferred.
- Experience in facility fit assessments, technology transfer of both USP and DSP process.
- Should have worked with late stage and commercial biologics with experience in process characterization, process validation and other BLA enabling studies and CPV programs.
- Experience overseeing 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.