Manager - Drug Product 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 patients' lives.
As a member of the Allakos team, you will have the opportunity to be a part of a dynamic Drug Product Development Team. The candidate will primarily be responsible for supporting technology transfer projects for the aseptic fill and finish of pharmaceutical and biological drug products to Contract Manufacturing Organizations (CMOs). Responsibilities include designing experiments/studies, authoring protocols (e.g., engineering runs; process performance qualifications), reviewing and analyzing complex data, and authoring process validation protocols and reports. Support the development of manufacturing production records.
Previous expertise with fill/finish operations for prefilled syringes, aseptic and/or isolator manufacturing, process validation/process performance qualifications, and technical writing are critical to this role. The candidate must also have excellent communication skills, both written and verbal.
- Act as key technical lead for fill-finish process development of prefilled syringes
- Collaboratively design, manage, and interpret studies for process development, process optimization, scale-up, manufacturing records, and technology transfer.
- Contribute to the compilation and review of master/batch production records, change controls.
- Independently author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
- Occasional travel (<10%) to serve as person-in-plant, as needed
- Provide technical support for fill-finish manufacturing activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change, and optimization, as applicable
- Support Regulatory Authoring (IIND, BLA)
Qualifications and Expertise:
- B.S. in Science or Engineering with a minimum of 7 years of equivalent job experience. M.S in Science or Engineering with a minimum of 4 years of equivalent job experience.
- Experience and knowledge of sterile processing principles (aseptic or isolator technology).
- Experience with Drug/Device or Biologic/Device combination products is a must.
- Working knowledge of relevant FDA, EU, ICH guidelines and GMP regulations, Process Validation/Qualification principles, and aseptic processing principles, PDA Technical Reports 22, 26, 60, 73, and 79
- Ability to manage multiple priorities and tasks in a dynamic environment.
- Contract fill-finish manufacturing experience
- Preferred: Experienced in process validation for Combination products
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.