Associate Scientist, Downstream Process Development - Contract - Gaithersburg, MD
Proclinical is seeking an Associate Scientist to join a dedicated Downstream Process Development team.
Primary Responsibilities :
This role will focus on developing, scaling up, and providing technical support for cGMP manufacturing of protein-based vaccines.
The successful candidate will ensure the creation of scientifically sound and scalable purification processes and generate materials for developmental studies.
Skills & Requirements :
- Relevant scientific discipline (MS or BS) with hands-on downstream purification experience.
- Proven history in purification of biologics and experience in chromatography methods and TFF unit operations is a plus.
- Ability to perform multiple functions in a fast-paced environment.
- Excellent record keeping skills is a necessity in order to adequately record, analyze and document data.
- Good organization skills.
- Demonstrated scientific and technical communication skills, both verbal and written.
- Proficiency in Window based software including Excel, PowerPoint and Word.
- Must be a highly self-motivated, organized, and productive individual.
The Associate Scientist's responsibilities will be :
- Support the development of purification processes by reviewing and compiling relevant literature data.
- Perform scale-up of processes to deliver materials for pre-clinical and clinical studies.
- Execute optimization experiments to ensure robust, high-purity, and scalable processes for clinical stage manufacturing.
- Design experimental work under the supervision of senior scientists.
- Process complex data and clearly communicate the implications of the results.
- Generate, manage, evaluate, and maintain critical data in an organized manner and provide assessment reports.
- Provide reagents and other supplies for various projects and departments.
- Support process characterization studies, process validation, and tech transfer processes as needed.
- Maintain inventory of lab supplies and order lab consumables as needed.
- Prepare buffers and pack columns at different scales.
- Test in-process samples using methods such as SDS-PAGE, Western blot, A280 (Nanodrop), BCA, DNA, and host cell protein ELISA assays.
- Operate glass washing instruments and autoclaves as needed.
- Engage hands-on in laboratory and scale-up operations.
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