Senior Scientist, Upstream Process Development
Proclinical is currently recruiting for a Senior Scientist, Upstream Process Development for an exciting and rapidly growing biotech company near Gaithersburg, MD. As the Senior Scientist Upstream Process Development, you will be play a leading role on upstream process development; scale up, and technical support of cGMP manufacturing and be responsible for generating materials for pre-clinical studies and other development purposes.
- Design experimental work independently or with minimal supervision.
- Perform hands on work in a cell culture lab, specifically cell culture expansion as well as process scale up and implementation into GMP clinical production suites.
- Design and execute process development studies to develop a thorough understanding of operating and performance parameters.
- Ability to process complex data and communicate clearly and timely the implications of the results.
- Perform and analyze Design of Experiment (DOE) studies to develop or optimizing processes to ensure a phase-appropriate, consistent, high-yielding, and scalable upstream process.
- Generate, manage, evaluate, and maintain critical data in a highly organized manner.
- Assist in scale up and optimization of early-stage processes, support critical operations as needed in our GMP manufacturing facility and deliver materials for pre-clinical and clinical studies.
- Provide reagents and other supplies for various projects and departments.
- Support process characterization studies and tech transfer process. As needed, support process validation, including validation protocol writing, execution and report writing.
Skills and Requirements:
- BS or MS degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline.
- Previous experience with suspension cell culture systems.
- Solid and hands-on upstream experience is required.
- A previous track record of culture process development experience such as cell passaging, formulation of media, aseptic technique processing, and managing reagents.
- Practical demonstration of hands-on process development including use of statistical design of experiments is required.
If you are having difficulty in applying or if you have any questions, please contact Alex Tooulas at (+1) 917-284-9670 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.