Jeffrey Williams
- Role
- Senior Process Engineer Ii at Bluebird Bio
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Jeffrey Williams
Seasoned process engineer with over a decade of experience in CGT and biologics…
Experience
Senior Process Engineer Ii
Dec 2022 — Present
Serves as accountable technical leader for all unit operations at a CMO• Collaborates cross-functionally within bluebird to ensure robust supply of autologous cell therapies (Drug Product) and CMO performance• Collaborates with MSAT counterparts at CMOs to deliver timely and correct technical solutions to resolve investigations and to improve manufacturing performance and reliability• Ensures timely review of process data and develops strategy and execution plan to improve process robustness• Ensures that standardized root cause analysis and statistical approaches are utilized to support investigations• Stays current on evolving GMP requirements and latest regulatory guidance• Supports regulatory inspections• Leads technology transfers and process validation of upstream, downstream, or fill/finish unit operations• Leads complex investigations to ensure timely resolution and delivers robust technical package to support lot disposition
Skills
- Software Documentation
- Microsoft Excel
- Laboratory Skills
- Microsoft Office
- Word
- Laboratory
- Batch Processing
- Standard Operating Procedure (Sop)
- Purification
- Chromatography
- Biotechnology
- Gmp
- Sop
- Excel
- Glp
- High-Performance Liquid Chromatography (Hplc)
- Aseptic Technique
- Aseptic Processing
- Elisa
- Validation
- Akta
- Cgmp
- Life Sciences
- Documentation
- Good Laboratory Practice (Glp)
- Analytical Skills
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