Engineer II, Downstream Development, Viral Vector Product Development
About The Position
The candidate contributes to the Viral Vector Product Development group through the design and execution of experiments based around downstream AAV (Adeno-Associated Virus) manufacturing processes. They will contribute to the purification team through generating, summarizing, and presenting experimental data to inform and recommend process operating conditions, with the goal of developing robust and scalable manufacturing processes. They will additionally draft documentation and provide expertise to support scale-up and tech transfer to clinical/commercial manufacturing facilities as well as submission of regulatory filings.
Requirements
- BS or MS degree in Biological Engineering, Chemical Engineering, Biochemistry, or related discipline w/ 3+ years (BS) or 0-year (MS) experience in biotech industry, including internships or co-op experience.
- Wet lab experience required.
- The duties of this role are conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Nice To Haves
- Experience with purification techniques (Clarification, NFF, chromatography, UF/DF)
- Experience authoring technical documents (tech transfer, batch records, IND supporting documents)
- Proficiency in MS Excel, experience with statistical data analysis and design of experiment (DOE) using software tools such as JMP.
Responsibilities
- Support the downstream development of AAV manufacturing processes to optimize the viral vector purification steps (chromatography, filtration, UF/DF)
- Independently perform OFAT and DoE-directed experiments to identify key and critical process parameters and to identify and recommend acceptable ranges for process scale-up and tech transfer.
- Document experiments, compile analytical data, and summarize findings in lab notebook entries and reports.
- Support tech-transfer of manufacturing processes to external partners. At times provide person-in-plant (PIP) support to ensure successful operation
- Manage and maintain lab equipment and supplies, ensuring a safe and efficient work environment. This includes regular lab cleaning, equipment maintenance, and supply procurement.
- Collaborate with cross-functional teams including Upstream, Process Analytics, and Research
- Coordinate with the process analytics and method development team to align sample submission requests and process workflows.
- Support authoring of development reports, tech transfer documents, and other relevant process/regulatory documents for pipeline programs and research collaborations
- Engage in platform development for the evaluation and implementation of novel technologies to improve purification efficiency and product quality.
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
Number of Employees
1,001-5,000 employees
