Manager, Drug Product Process Development
Manager / Drug Product 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 patients' lives.
Position Summary: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, aseptic and 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 process development. Collaboratively design and manage studies for process development, process optimization, scale-up, manufacturing records, and technology transfer.
- Independently design studies for evaluating the robustness of the manufacturing process. These studies will serve as a baseline for further process validation activities.
- Independently evaluate process data and perform an in-depth analysis using scientific principles for evaluating critical process parameters governing the performance of the process. Exercises judgment in selecting methods, techniques, and evaluation criteria.
- Participate in technology transfer to/from CDMOs and scale-up activities.
- Contribute to the compilation and review of master/batch production records, change controls.
- Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes
- Independently author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
- Serve as person-in-plant, as needed
- Ensure that assigned processes are cGMP compliant and meet the U.S FDA regulations and the EMEA regulations.
- Provide technical support for fill-finish manufacturing activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change, and optimization, as applicable
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.
- Hands-on experience with the aseptic liquid filling of vials. Familiar with current varieties and suppliers of parenteral vials and stoppers.
- Hands-on experience with sterile filtration unit operations and a variety of filter membranes and manufacturers. Experience working with filter manufacturers on the design filter validation studies is a plus.
- Hands-on experience with best current practices and trends in disposable sterile technologies.
- Working knowledge of relevant FDA, EU, ICH guidelines and GMP regulations, Process Validation/Qualification principles, and aseptic processing principles
- Experience with processes development, process scale-up, and optimization of drug product manufacturing
- Ability to manage multiple priorities and tasks in a dynamic environment.
- Experience and knowledge of sterile processing principles (aseptic or isolator technology).
- Experience with process scale-up/scale-down and technology transfer of FDA-regulated manufacturing processes
- Preferred: Hands-on experience with aseptic lyophilization and aseptic filling of pre-filled syringes
- Preferred: Fluent in PDA Technical Reports 22, 26, 60, and 79
- Preferred: Knowledge of statistical design of experiments (DoE) and analysis
- Preferred: Contract fill-finish manufacturing experience