Associate Director, Downstream Process Development
Associate Director, Downstream Process Development Allakos 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:As a member of the Allakos team you will have the opportunity to be a key member of the Biologics DS development and Tech Transfer team and responsible for activities related to Downstream Process Development of our late-stage clinical biologic (Mab) molecule AK002 and other early-stage programs. This position will be responsible for the Process Development, Tech Transfer, and oversite of Engineering/Clinical batches at contract manufacturing site/s. Additionally, there will be a strong focus on BLA-enabling activities including process characterization, PPQ Batches and BLA authoring and review.
- Provide technical leadership to the Downstream Process Development group and technology transfer of AK002 process to CMO sites.
- Accountable for activities pertaining to the downstream process development lab. Supervise planning and execution of experiments. Analyze results and communicate them effectively to management.
- Coordinate with Upstream Development, Analytical, and Facilities departments to successfully complete the DSP activities.
- Provide input for the strategy and experimental plan for downstream process characterization studies. Generate protocols, supervise execution, use statistical tools to analyze results, and review reports for studies.
- Assist in the planning of downstream process development experiments for new molecules and supervise execution of the same.
- Supervise the Engineering and Clinical batches at CMOs, review and approve Deviations and CAPA documents for these batches.
- Plan and supervise PPQ batches at CMOs. Review and approve protocols and reports for PPQ batches.
- Author BLA submission documents.
- Travel domestically and internationally up to 10% of the time.
What We Value:
- At least 12 years of relevant experience (10+ with M.S., 8+ for Ph.D.) successfully working in the biopharmaceutical industry with proven track record of leadership and success.
- At least 5 years managing cross functional projects and leading teams.
- Extensive experience in Downstream Process Development and process characterization of biologics, such as Mabs and fusion proteins.
- Strong background in statistical design of experiments (DoE) and associated analysis
- Experience in technology transfer and facility fit assessments.
- Should have worked with late and commercial stage 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.
- Experienced 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.