Process Development and Manufacturing Specialist (Upstream Team)

at University of Wisconsin, Waisman Biomanufacturing (view profile)
Location Madison, WI
Date Posted February 28, 2020
Category Biotechnology
Job Type Full-time
Address 1500 Highland Ave

Description

Process Development and Manufacturing Specialist

Waisman Biomanufacturing offers a unique opportunity to be part of a team dedicated to the production of novel therapeutics for human clinical trials across the US and beyond. Our wide range of projects and clients enable team members to broaden their skill sets, operate cutting edge equipment, and manage complex projects. We are inspired and motivated through work to help patient populations suffering from diseases without cures. Read more about the specific requirements for this opening on the Upstream Biomanufacturing Cell Therapies team and apply to join our dynamic group.

Waisman Biomanufacturing, at the University of Wisconsin-Madison is a clinical manufacturing facility that produces biologics (gene therapeutics, cell therapeutics, recombinant proteins and vaccines) for Phase I and II Human Clinical Trials in compliance with current Good Manufacturing Practice (cGMP) guidelines.

The Process Development and Manufacturing Specialist develops and supports process development and manufacturing operations and functions as a team or project lead to facilitate smooth and timely execution of projects. A Bachelor's Degree is required, preferably in microbiology, cell biology, molecular biology, biochemical or chemical engineering, or related field. Previous work experience or relevant undergraduate research experience in cell culture is required.

The following experience is preferred:

  • One to three years of experience working in a research laboratory, Biomanufacturing and/or process development of biopharmaceuticals.
  • Experience in any of the following: aseptic technique related to mammalian cell and/or microbial culture; suspension and/or adherent cell culture; large format cell expansion.
  • Experience with laboratory equipment/analytical methods (e.g., bioreactors, metabolite bioanalysis, transfection, qPCR, flow cytometry, gel electrophoresis, western blots).
  • Familiarity with current Good Manufacturing Practices (cGMPs) and application to the manufacture of biopharmaceuticals or biologics, particularly cell therapies.
  • Experience with equipment operation and/or the flexibility and desire to learn operation of new equipment.
  • Excellent verbal and written communication skills.
  • The ability to work effectively both independently and collaboratively in a fast-paced, client-oriented, team environment.
  • Self-motivated with an enthusiastic, positive attitude, and excellent multi-tasking skills.

Principal duties:

  • Perform process development and cGMP manufacturing of biopharmaceuticals for use in various clinical trials. (25%)
  • Develop and execute Standard Operating Procedures (SOPs) and Manufacturing Formulas (MFs) to support manufacturing activities. (15%)
  • Complete manufacturing documentation, prepare reports, and present findings to internal and external audiences. (15%)
  • Prepare and validate equipment and stage materials for manufacturing operations. (15%)
  • Plan and execute client projects. Provide updates on project components and timelines to stakeholders as needed. (10%)
  • Co-develop manufacturing processes to produce scalable, repeatable methods to achieve required levels of quality and purity. (15%)
  • Participate in mandatory trainings and seminars such as training in cGMPs for early-stage clinical trials (phase I/II) and learning process methods through seminars and hands-on training. (5%)

To find out more and to apply, please visit: https://jobs.hr.wisc.edu/en-us/job/503836/process-development-and-manufacturing-specialist

 

Unless confidentiality is requested in writing, information regarding applicants must be released upon request. Finalists cannot be guaranteed confidentiality. UW–Madison provides equal employment opportunity for all persons and is in compliance with State and Federal regulations.

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