What You’ll do:
Independently develop and evaluate process changes and new technologies to optimize the existing upstream AAV process to enhance robustness, scale-ability, and/or yield.
Work independently and with a team to manufacture AAV in shake flasks or bioreactors.
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 planning, processes, and projects.
Independently analyze and interpret data, draft technical summary reports, and present results to cross functional teams.
Follow data integrity practices 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, Manufacturing, Regulatory, 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.
Routinely mentor junior associates on scientific background and technical aspects of work.
About You:
BS with 5+ years of experience in Chemical Engineering, Biochemistry, Cell & Molecular Biology or related life science engineering fields.
Hands on experience with bioreactors at small/pilot/large scale is required.
Working knowledge of analytical assays used to support development such as PCR, cell-based assay, gels, etc.
Broad experience in cGMP biologics manufacturing and documentation required, with additional understanding of regulatory guidelines preferred.
Organized when juggling multiple projects at the same time and prioritizing one’s own projects.
Experience drafting study plans, SOPs, Batch records, technical reports, and protocols and presentations on work performed is required.
Highly motivated team player capable of leading by example and who exceeds expectations in all aspects of the role.
Hands-on experience in the insect cell-baculovirus expression technology platform is a plus.
