Process Development Engineer II - Downstream
1035 O'Brien Drive Menlo Park, CA 94025
Process Development Engineer II – Downstream
Menlo Park, CA (relocating to Redwood City in late 2019)
- Work independently and with a team to manufacture AAV through the downstream purification process (post cell lysate to final formulation and final fill), purifying starting material from small shake flask to large bioreactor productions.
- Independently develop and evaluate process changes and new technologies to optimize the existing downstream AAV process to enhance robustness, scale-ability, and/or yield.
- Provide hands-on help and technical leadership in developing and qualifying scale-down / up models of the platform process.
- Author and review technical documentation including batch records, Tech Transfer protocols, Campaign Summaries, and risk assessments.
- Research and provide technical feedback during group discussions on downstream planning, processes, and projects.
- Independently analyze and interpret data, draft technical summary reports, and present results to cross functional teams.
- Perform molecular biology assays (ie: qPCR, silver stain, ELISA, HPLC, etc.) to support Process Development.
- Follow GMP documentation to maintain accurate records through a highly organized lab notebook and data logging of process data.
- Independently identify and solve complex technical problems of limited scope while providing solutions to management.
- Search literature for methods, processes, and new technologies for downstream AAV process.
- Emphasis of Quality Control, Quality Assurance, and Consistency throughout lab work performed.
- Collaborate and interact with R&D, Assay Development, Quality, and Pre-Clinical groups to provide support on as-needed basis.
- Ensure safe workplace in compliance with the company and EHS' rules and regulations.
- Provide support for external manufacturing by reviewing and approving batch records, performing tech transfers, and providing technical support and PIP on as-needed basis,
- Represent company to third parties (CMOs, vendors, collaborators, trade shows, training, etc.) in a professional manner.
POSITION REQUIREMENTS AND EXPERIENCE:
- MS with 2+ years of experience or BS with 4+ years of experience in Chemical Engineering, Biochemistry, Cell & Molecular Biology or related life science engineering fields,
- Hands on experience with TFF (Hollow Fiber / Cassettes) UF/DF, and/or GE AKTA (Avant, Pilot), chromatography at small/pilot/large scale is required.
- Additional experience with fill / finish is a plus.
- Understanding of theory of chromatography, protein purification, and TFF.
- Proficient in general molecular biology techniques and assays including qPCR, SS, ELISA, HPLC, and/or Mass Spectrometry.
- Organized when juggling multiple projects at the same time and prioritizing own projects.
- Experience drafting study plans, SOPs, Batch records, technical reports, and protocols and presentations on work performed is required.
- Broad experience in cGMP biologics manufacturing and documentation required, with additional understanding of regulatory guidelines preferred.
- Highly motivated team player capable of working with others in a fast pace environment.
- Ability to use Microsoft Excel, Word, PowerPoint. Experimental design software, and statistical data analysis software a plus.
- Hands-on experience in the insect cell-baculovirus expression technology platform is a plus.
- Good to have – 5S or similar experience