Associate Director, Upstream Process Development
Associate Director, Upstream 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:As a member of the Allakos team you will have the opportunity to lead the late stage upstream process development team focused on activities supporting the lirentelimab commercial launch scale and the large scale manufacturing for Chinese hamster ovary (CHO) monoclonal antibody production. The Principal Scientist / Associate Director position will manage a team responsible for in-house process characterization studies, technology transfer enabling studies for large scale manufacturing, and contract manufacturing organization (CMO) oversight at the commercial launch site. This person will also author CMC sections of biological license applications (BLA) and support the technology transfer. This position will collaborate with the Large Scale Drug Substance manufacturing team to perform facility fit assessments and technology transfers. The Principal Scientist / Associate Director will also work closely with the Downstream Process Development, Analytical Development and Quality Control, Quality Assurance, and Regulatory Affairs groups. This position reports to the Director, Upstream Process Development.
- Lead the design, execution, and statistical data analysis of process characterization studies including authoring of associated protocols and reports
- Supervise the team responsible for planning and execution of upstream process development studies and ensure effective communication of study results
- Author CMC sections in BLA submissions
- Work with Large Scale Manufacturing team to transfer processes to large scale CMOs and serve upstream subject matter expert (SME) in facility fit and technology transfer assessments
- Supervise the management of the upstream manufacturing process at the lirentelimab commercial launch CMO site including manufacturing batch oversight, and review of deviations, change controls, CAPAs, and validation protocols and reports
- Provide oversight to cell bank manufacturing and storage
- Represent the upstream process development team in internal and external meetings
- Travel domestically and internationally up to 10% of the time
Qualifications and Expertise:
- B.S./M.S./Ph.D. in Chemical Engineering, Biology, or other relevant life sciences field with at least 12 years of relevant experience for B.S., 10 years for M.S., and 8 years for Ph.D.
- At least 5 years managing teams and cross functional projects
- Must have extensive experience in CHO cell culture process development and process characterization for production of monoclonal antibodies or other therapeutic recombinant proteins
- Must have a strong background in design of experiments (DoE) methodology and statistical data analysis techniques.
- Experience in technology transfer and facility fit assessments is required
- Must be experienced in BLA submission authoring
- Experienced in people and stakeholder management, conflict resolution, and building consensus
- Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams
- Ability to travel up to 10%