Senior Scientist - Upstream Process Development

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)
  3. United States
Baltimore, USA
Posting date: 19 Jan 2021
QA.CD.35086

Proclinical is currently recruiting for a Senior Scientist of Upstream Process Development with a leading pharmaceutical company located in Baltimore, MD. As the Senior Scientist, you will ensure scientifically sound design and scalable upstream processes are created. The candidate will also be responsible for generating materials for pre-clinical studies and other development purposes. The candidate is expected to be highly self-motivated, well organized and very productive.

Job Responsibilities:

  • Design experimental work independently or with minimal supervision.
  • Perform hands on work in a cell culture lab, specifically cell culture expansion, vaccine production 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. Provide reports for assessment by senior management.
  • 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.
  • Collaborate and coordinate with colleagues from Discovery, Process Development, Analytical Development, Manufacturing, and QA/QC teams.
  • Support process characterization studies and tech transfer process. As needed, support process validation, including validation protocol writing, execution and report writing.
  • This position is expected to be mainly hands on in the laboratory.

Skills and Requirements:

  • Requires PhD in relevant field or a minimum of 10 years relevant experience with a Master's degree.
  • Previous experience with suspension cell culture systems, vaccine and/or viral vector production is desired.
  • Solid and hands-on upstream experience is required. Multi-year industrial purification experience with vaccines/biologics is preferred; direct experience with virus-derived recombinant products and/or viral particles is a plus.
  • 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. Experience with automation technologies is desired.
  • Ability to think critically, demonstrate troubleshooting and problem-solving skills.
  • Excellent interpersonal, verbal, and written communication skills are essential.
  • Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements.
  • Self-motivated with a strong sense of ownership in areas of responsibility and willingness to accept temporary responsibilities outside of initial job description.

If you are having difficulty in applying or if you have any questions, please contact Christian Delbaere at (+1) 347-227-1672 or c.delbaere@proclinical.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.

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