Associate Scientist, Downstream Process Development

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Job Description - Associate Scientist, Downstream Process Development

Associate Scientist, Downstream Process Development - Contract - Gaithersburg, MD

Proclinical is seeking a dedicated and innovative Associate Scientist to join our Downstream Process Development Department. This is a contract position based in Gaithersburg, MD.

Primary Responsibilities:

The successful candidate will play a pivotal role in the development, scale-up, and technical support of cGMP manufacturing for protein-based vaccines. This role involves designing scientifically sound and scalable purification processes, generating materials for developmental studies, and providing technical support. The ideal candidate will be self-motivated, well-organized, and highly productive.

Skills & Requirements:

  • MS in a relevant scientific discipline or BS with relevant experience.
  • Hands-on Downstream purification experience.
  • Knowledge in purification of vaccines/biologics; Experience in various chromatography methods, filtration, and TFF unit operations at bench scale and/or pilot scale is a plus.
  • Capable of performing multiple functions in a fast-paced environment.
  • Strong technical protocol/report writing, and good organization skills.
  • Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements.
  • Demonstrated verbal and written skills in communicating scientific and technical information.
  • Proficient in Window based software including Excel, PowerPoint and Word.

The Downstream Process Development Associate Scientist will:

  • 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 the process is robust, high in purity, yield, and scalable 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 a highly 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 process as needed.
  • Maintain inventory of lab supplies and order lab consumables as needed.
  • Prepare buffers and column packing at different scales.
  • Perform testing of in-process samples.
  • Operate the glass washing instruments and autoclaves as needed.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) or .

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.

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