Manager/Sr Manager of External DS Manufacturing
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.
Allakos is seeking to recruit a Manager/Senior Manager position within the Technical Operations department to join our expanding team. This position will specialize in scale up and transfer of Drug Substance processes to CMO organizations. Scope of the position and requirements are described below.
The Manager/Senior Manager will report to the Associate Director of External DS Manufacturing and would be key member of DS supply team responsible for supporting of all activities related to DS manufacturing of our late stage clinical biologics (Mab) molecule AK002 at the CMO’s site. This position would be responsible for assisting tech transfer, monitoring of engineering and Clinical batches, and support for BLA enabling activities, PPQ Batches and commercial production at the CMO site.
- Perform/review facility fit and technology transfer of AK002 process to a CMO site
- Support Engineering and Clinical batches at the CMOs, Review and approve Process Description, Batch records, Bill of Materials, Bill of Parameters, deviations and CAPA documents for these batches
- Monitor process performance of 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 7 years of relevant experience (5+ with MS, 3+ 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 manufacturing of biologics using CHO cells in cGMP setting. Experience with Single Use facility preferred
- Experience in facility fit, scale up and technology transfer of USP/Cell Culture process required.
- Experience with late stage and commercial biologics and understanding of process characterization, PPQ batches, CPV programs and other BLA enabling studies.
- Experience in 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.
The salary is competitive and commensurate with experience and qualifications.
The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership.
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.