9 Scientist II, Process Sciences, Process Development Jobs in Gaithersburg, MD
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Scientist II, Process Sciences, Process Development
$134k-168k (estimate)
Full Time | Ambulatory Healthcare Services
7 Days Ago
Green Key Resources is Hiring a Scientist II, Process Sciences, Process Development Near Gaithersburg, MD
Responsibilities
- Develop robust, high-producing, scalable and economically viable cell culture production processes up to large-scale bioreactors.
- Develop, optimize and scale-up fed-batch bioreactor processes. Lead efforts to evaluate different cell culture media and feed formulations. Evaluate optimal feeding strategies to improve product yield, quality and purity.
- Perform and analyze Design of Experiment (DOE) studies to fully characterize processes. Support process validation studies and activities. Participate in the technology transfer of processes to Manufacturing and external collaborators and partners.
- Perform critical operations as needed in our development and cGMP manufacturing facilities to deliver pre-clinical and clinical materials.
- Support the build-up of our scale-up facility for upstream operations to generate material for downstream
- Generate, manage, evaluate, and maintain critical data in a highly organized manner. Provide reports for assessment by senior management.
- Assist in scale up and optimization of early-stage upstream processes, support critical operations as needed in our GMP manufacturing facility and deliver materials for pre-clinical and clinical studies.
- Complete process robustness and characterization studies for tech transfer documents to support scale-up to our manufacturing plants. As needed, support process validation, including validation protocol writing, execution and report writing.
- PhD with 2 - 5 years directly related industry experience, MS with 6 - 8 years directly related industry experience or BS with more than 10 years of directly related industry experience.
- Experience with developing fed-batch bioreactor processes including optimizing feeding strategies and evaluating different cell culture media and feed formulations.
- Experienced in process optimization, scale-up and technology transfer
- Extensive experience with small-scale and large-scale cell culture bioreactor process development is required. Experience with insect and/or mammalian is preferred
- Hands-on experience in the operation of single use bioreactor up to pilot scale and supporting tech transfer to manufacturing plants
- Demonstrated of hands-on experience in process development including use of statistical design of experiments is required.
- Working knowledge of Cell Clarification/Harvest and Downstream purification is a plus
- Demonstrated verbal and written skills in communicating complex technical information.
- Ability to critically analyze data using statistical tools and to compile technical reports.
- Excellent record keeping abilities to adequately record, analyze and document development data generated in support of regulatory requirements.
- Experience with JMP or other similar software, a plus
Job Summary
JOB TYPE
Full Time
INDUSTRY
Ambulatory Healthcare Services
SALARY
$134k-168k (estimate)
POST DATE
06/23/2024
EXPIRATION DATE
08/06/2024
WEBSITE
greenkeyllc.com
HEADQUARTERS
POTOMAC, MD
SIZE
500 - 1,000
FOUNDED
2004
CEO
CHELSEA MURPHY
REVENUE
<$5M
INDUSTRY
Ambulatory Healthcare Services
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