Senior Scientist, Downstream Process Development

Malvern, PA
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 275839

Date Posted: 01/14/2022


Title: Sr. Scientist- Downstream Process Development  

Location: Malvern, Pa

Schedule: M-F 9am-5pm

Type: Permanent/Direct

Start date: Immediate

Responsibilities:

  • Perform process development of the cell culture or purification process steps within
  • Primary responsibilities will include participating in the design of experiments, executing the planned experiments, and optimizing the process steps to the target process scale. This will include laboratory and occasional pilot-scale scale work with bioreactors, chromatography systems and filtration
  • Design, develop and execute processes for the recovery and purification of biological materials to optimize production and reduce variability in drug substance and drug product manufacturing, specifically relating to vaccine and gene therapeutic process development.
  • Design and execute development studies (DoE) in the in-house PD lab to identify and determine appropriate conditions and ranges of (critical) process parameters for chromatographic purification & separation and several types of filtrations (process optimization).
  • Perform assays on gene therapeutic, biologics and/or vaccine products, process intermediates, and related experimental samples using biochemical/analytical tests.
  • Record and analyze experimental data, verify data integrity and accuracy, and report/summarize findings to the project team, and also draft technical documents and support technology transfer to collaboration partners following good manufacturing practices (GMP).
  • Participate in routine meetings CRO/CMO to manage the downstream activities drafting and reviews of various documents such as study design, protocols, batch records, and reports.
  • Expected to work in a team environment as well as contributing individually to meet project timeline and
  • Prepare solutions/reagents. Set up process equipment for lab-scale experiments.
  • Contribute to conducting a root cause analysis and assist in implementing proposed corrective actions regarding downstream process-oriented systems.
  • Contribute to downstream process development sections of CMC modules in regulatory documents including IND, NDA, BLA, MAA and other regulatory
  • Contribute to process development team in the development of high-quality product and in-process methodology as per regulatory

Requirements:

  • PhD in Chemistry, Biochemistry, or Analytical Science with 5+ years of pharmaceutical CMC industry experience and a demonstrated technical leadership in process development, vaccine and/or ophthalmology experience
  • Proven ability to provide process expertise on programs/project teams for pre-clinical and clinical studies with a wide variety of techniques and technologies.
  • Experience working in a GMP regulated
  • Strong scientific and operational background in the optimization and validation of downstream processing for harvesting, filtration, capture, and purification methodology.
  • Strong understanding of method development, technical transfer, and GMP Experience with IND and/or BLA submissions.
  • Detail-oriented, exceptional documentation practices, technical writing, and verbal communication skills
  • Excellent contingency planning and time management skills and demonstrated ability to manage several projects
  • Possess strong problem solving and analytical skills and be an independent and creative
  • Ability to navigate and be successful in a fast-paced, highly matrixed work

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S., we provide scientific, clinical, engineering, energy, IT, legal, and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.


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