Director, Downstream Process Development
Director, Downstream Process DevelopmentAllakos 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 Director, Downstream Process Development would be key member of Biologics DS development and tech transfer team and would be responsible for all activities related to Downstream Process Development of our late-stage clinical biologics (Mab) molecule AK002 and early stage program. This position leads the Purification Group which is responsible for the process development, tech transfer, supervision of Engineering and Clinical batches, BLA enabling activities, PPQ Batches and commercial production at multiple CMO sites, process characterization and BLA authoring and review.
- Provide technical and managerial leadership to the Downstream Process Development group and technology transfer of AK002 process to CMO sites.
- Accountable for all activities pertaining to the downstream process development lab. Supervise planning and execution of experiments. Analyze results and communicate it effectively to management.
- Coordinate with Upstream development, Analytical and Facilities department to successfully complete the DSP activities
- Provide overall strategy and experimental plan for downstream process characterization studies. Generate protocols, supervise execution, use statistical tools to analyze results and review reports for studies.
- Plan the downstream process development experiments for new molecules and supervise execution of the same.
- Supervise the Engineering and Clinical batches at the CMOs, Review and approve Batch records, Bill of Materials, Bill of Parameters, Batch records, deviations and CAPA documents for these batches
- Plan and supervise PPQ batches at CMOs. Review and approve protocols and reports for PPQ batches
- Author and review BLA submission documents
- 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
- Travel domestically and internationally up to 10% of the time
Qualifications and Expertise:
- 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 Downstream process development and process characterization of biologics molecules such as Mabs and fusion proteins.
- Experience in technology transfer and facility fit assessments
- Should have worked with early and late stage and commercial biologics with experience in process development, process characterization, PPQ batches and other BLA enabling studies and CPV programs.
- Experience working with Contract Manufacturers is preferred.
- Experienced in BLA submission write ups.
- Experience in people and stakeholder management, conflict resolution and building consensus.
- Good understanding of cGMP-regulations 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.