
Manufacturing Specialist
- La Verne, CA
- $107,185-138,710 per year
- Permanent
- Full-time
- Demonstrates hands-on technical leadership of process development, technology transfer, and process operations within a phase appropriate cGMP environment.
- Responsible for executing technology/process transfer from Lab to manufacturing production floor and provide technical input and support during manufacturing of drug products.
- Lead the design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis.
- Author or review technical documentation (development reports, process description, process flow protocols, batch records, etc)
- Mentor junior team members on process operations and development strategies, experimental design and execution as well as process transfer.
- Participate in cross functional initiatives,
- Adhere to department budget and all training, compliance, and safety requirements.
- Strong understanding of biologics/sterile injectable product manufacturing processes e.g., bulk freeze/thaw, mixing/pooling, filtration, filling and/or lyophilization
- Experience supporting drug product manufacturing operations, technology transfer, and/or development. Prior experience with commercial manufacturing and/or process validation is highly desirable.
- Hands-on experience with process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, formulation development and technical transfer.
- Broad understanding of downstream development and scale up including process transfers for new product introduction into the production lines.
- Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
- Working knowledge of cGMPs and regulatory requirements of biopharmaceutical manufacturing
- Experience in cleaning process design, verification, and cross contamination strategies.
- Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.