Position Summary:

Your Role:

• 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.