A career with EMD Serono 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. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
Associate Scientists Upstream Process Development
Job Location: 45A Middlesex Turnpike, Billerica, Massachusetts 01821
This position qualifies for EMD SRDI’s employee referral program.
- Perform Good Laboratory Practice (GLP) toxicology protein production, manufacturability and reference runs, which includes cell line expansion, operation of bioreactors at scale of 125mL- 3L flasks, 30mL – 600mL spin tubes, 3L -5L bioreactors, 2L - 50L Waves, and 200L Mobius CellReady Bioreactor;
- Write and execute batch records and standard operating procedures (SOP) related to upstream process operation of GLP protein production, manufacturability, reference runs, and other pre-clinical process optimization;
- Write technical reports and documents to transfer upstream processes to Global Manufacturing and Supply Team as required;
- Provide expertise and insight to guide development of appropriate upstream procedure which includes cell line expansion, operation of bioreactors, and operation of clarification;
- Develop novel bioreactor processes, as well as standard methods to produce proteins from the milligram to gram scale;
- Perform small scale spin tube studies to determine optimal condition for growth and productivity of cell lines;
- Apply Design of Experiment (DoE) execution and statistical analysis using statistical software (JMP and Minitab) to develop, tweak, and refine upstream processes in order to improve titer, post-clarification yield, while meeting acceptable quality criteria; and
- Provide reports and prepare scientific presentations/seminars as needed.
Requirements and Qualifications:
Employer requires a Master’s Degree in biotechnology, biochemistry, or related field, 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 in the upstream process stage within a pharmaceutical or biotechnology industry.
Additionally, the successful candidate must have:
- Demonstrated knowledge of protein production for pre-clinical studies, upstream process development of biologics, data analysis, and project reporting gained through one (1) year of work experience;
- Demonstrated ability to perform mammalian upstream production of GLP toxicology drug substance and develop processes at bench scale up to 200L bioreactors for a variety of therapeutic candidate proteins gained through one (1) year of work experience;
- Demonstrated knowledge of Good Laboratory Practices (GLP), applications, and techniques of bench scale bioreactor systems gained through one (1) year work experience; and
4. Demonstrated ability to critically analyze data collected from bioprocess experiments using statistical tools (JMP,
Minitab, and Excel Pivot Table) and complete technical reports gained through one (1) year of work experience.
All years of work experience may be gained concurrently.
Please send resumes to EMD Serono Research & Development Institute, Inc. 400 Summit Drive, Burlington, MA 01803 (Req #: 200669 ).
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