Sr Manager/Associate Director of Large Scale External DS Manufacturing
Sr Manager/Associate Director of Large Scale External DS 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.
Job Description:As a member of the Allakos team you will have the opportunity to scale up and transfer Drug Substance (DS) processes to CMO organizations. The associate Senior Manager/Associate Director will report to the Director of Large Scale DS Manufacturing and would be key member of DS supply team responsible for supporting of all activities related to Large Scale manufacturing (up to 20kl) by working with various CMO’s of our late stage clinical biologics (Mab) molecule AK002.
- Perform/review facility fit and technology transfer of AK002 process to multiple large scale CMO sites
- Support 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
- Monitor process performance from on-going campaigns, identify performance issues and highlight areas of improvement
- 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
- Prepare for 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
- Provide technical input and expertise at 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 person-in-plant (PIP) support for critical manufacturing operations as per requirement
- Travel domestically and internationally up to 10% of the time
Qualifications and Expertise:
- At least 10 years of relevant experience (8+ with MS, 6+ for PhD) successfully working in biopharmaceutical industry with proven track record of leadership and success
- Experience managing cross functional projects and leading teams
- Experience with Large Scale manufacturing (larger than 10kl bioreactor and corresponding Purification scale) of biologics using CHO cells in cGMP setting
- Experience in facility fit, scale up and technology transfer of both USP and DSP processes
- 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 in people and stake holder management, conflict resolution and building consensus.
- Previously worked in a facility 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.