A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
Job Title: Associate Scientists Purification Process Development
Job Location: EMD Serono Research & Development Institute (SRDI), Inc., 45A Middlesex Turnpike, Billerica, MA 01821
The Associate Scientist Purification Process Development duties will encompass the following:
- Responsible for good laboratory practice (GLP) Toxicology drug substance production, which includes, protein purification, depth filtration, viral inactivation, nano-filtration, Ultrafiltration and Diafiltration (UF/DF), and biochemical and biophysical characterization of proteins;
- Execute protein purification with affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using AKTA AVANT and MOBIUS Flexready purification skid;
- Perform analyses including Sodium Dodecyl Sulfate-PolyAcrylamide Gel Electrophoresis (SDS-PAGE), Size Exclusion High Pressure Liquid Chromatography (SE-HPLC), Limulus Amoebocyte Lysate (LAL), host cell-DNA, host cell protein, as necessary;
- Write and execute batch records and Standard Operating Procedures (SOPs) related to GLP protein production, and Research Operating Procedures (ROPs) for novel purifications;
- Provide expertise and insight to guide development of appropriate purification methods;
- Develop novel purification processes as well as using standard methods to purify proteins from the milligram to gram scale. Processes will be multiple steps and must provide necessary clearance of viruses, endotoxin, and host cell proteins and DNA;
- Perform, develop, and optimize robust, efficient, scalable strategies for improving process performance;
- Engage in small-scale studies and pilot scale purification studies; and
- Apply design of experiments (DOE) methods to purification activities and analyze data for process characterization with JMP software.
Requirements & Qualifications:
- Masters in biotechnology, biochemistry, medicinal chemistry, chemical engineering, or closely related, plus one (1) year of work experience in protein production in a setting that adheres to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations.
- Demonstrated ability with purification unit operations including nano-filtration, depth filtration, viral inactivation, chromatography, TFF UF/DF, AKTA, UNICORN, and HPLC systems gained through one (1) year of work experience;
- Demonstrated ability with troubleshooting and maintenance of AKTA AVANT and Mobius FlexReady gained through (1) one year of work experience;
- Demonstrated ability in protein purification via affinity, hydrophobic interaction (HIC), ion exchange (IEX), size exclusion (SEC), and mixed-mode chromatography gained through one (1) year of work experience;
- Demonstrated knowledge and ability in biochemical characterization of proteins including analytical and biophysical techniques gained through one (1) year of work experience;
- Demonstrated ability in chromatographic resin screening and process optimization gained through one (1) year of work experience; and
- Demonstrated knowledge of design of experiments (DOE), compiling technical reports, and data analysis using statistical tool (JMP Software) gained through one (1) year of work experience.
All years of experience may be gained concurrently.
This position is eligible for the EMD SRDI, Inc. Employee Referral Program.
Qualified candidates should send resumes to:
EMD SRDI, Inc.
ATTN: Req #199733
400 Summit Drive
Burlington, MA 01803
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