Sr. Manager/Associate Director of Drug Product Manufacturing
Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.
The company is seeking to recruit a Sr. Manager/Associate Director of Drug Product Manufacturing.
The Sr. Manager / Associate Director, Drug Product Manufacturing will lead antibody contract manufacturing drug product fill activities. Management of CMOs is a critical aspect of the job and will include frequent visits to the contractors depending on the intensity of the on-going activities. This person will be responsible for the late stage development, BLA strategy and second source selection. This person will be responsible for technology transfer, scale up and the collection of data and the finalization of the reports and summaries required to support global regulatory submissions. This role involves significant cross functional collaboration with purification and formulation development, analytical development & quality control, CMC project management, quality assurance, regulatory and supply chain. This position reports to the Vice President, Technical Operations.
- Develop strategic phase-appropriate drug product development plans; responsible for drug product fill process, product quality and compliance;
- Serve as the subject matter expert in subcutaneous pre filled syringe presentation, container closure system, and drug product engineering.
- Provide PIP support in clinical and commercial drug product manufacturing at CMOs.
- Manage day-to-day activities to meet development timelines and support manufacturing of clinical and commercial batches
- Collaborate with CMC project manager to provide agenda and update on action items to CMOs on a regular basis
- Author and review drug product manufacturing and characterization sections of Regulatory submissions (i.e. IMPD/INDs/BLA), and responses to Regulatory agency questions.
- PhD in Life Sciences or relevant field with a minimum of 6 years of relevant industry experience, or BS/MS with a minimum of 10 years of relevant industry experience.
- Strong preference for at least 3 years of experience managing outsourced formulation development and drug product fill at contract organizations
- Broad, and in-depth expertise in mAb formulation (IV, SC, lyo) development
- Extensive experience with drug product fill process and solid knowledge of cGMP practices.
- Comfortable working in a fast-paced environment
- Experience with sterile, parenteral /injectable products
- Experience in setting process and product specifications
- Experience in designing and evaluating stability programs
- Direct experience preparing and reviewing CMC documentation for regulatory filings and inspections required.
- Position will require travel up to 10%, domestic and international.
The salary is competitive and commensurate with experience and qualifications.
Interested applicants please send resume to CMCcareers@allakos.com
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.