Process Development and Manufacturing Specialist (Downstream Team)

at University of Wisconsin, Waisman Biomanufacturing (view profile)
Location Madison, WI
Date Posted March 6, 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 United States and beyond. WB's wide range of projects and clients enable team members to broaden their skill sets, operate cutting edge equipment, and manage complex projects. WB is inspired and motivated through work to help patient populations suffering from diseases without cures. We are seeking highly motivated, independent yet team-oriented candidates with an enthusiastic and positive attitude, excellent multi-tasking skills and willingness to excel in a fast-paced, client-oriented, team environment.

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 will be responsible for developing and supporting manufacturing operations with any number of upstream or downstream processes, co-developing manufacturing processes, executing Standard Operating Procedures (SOPs) for manufacturing operations, conducting equipment and process validation of manufacturing processes, performing manufacturing activities under cGMPs and complete project assignments as required to support all of these. A Bachelor's Degree is required, preferably in microbiology, cell biology, molecular biology, biochemical or chemical engineering, or related field. Well-qualified applicants will have the following preferred experience:

  • One to three years of experience working in one of the following: research laboratory, pilot plant, biomanufacturing and/or in process development for biopharmaceuticals.
  • Experience in any of the following areas: microbial culture; purification of biological macromolecules, aseptic technique, (e.g. cell culture used in production of recombinant protein).
  • Familiarity with current Good Manufacturing Practices (cGMPs) and application to the manufacture of biopharmaceuticals or biologics.
  • Experience with laboratory equipment, as well as in-process analytical methods (e.g., gel electrophoresis, western blot, bioanalysis, nucleofection, quantitative polymerase chain reaction [qPCR], automated chromatography [AKTA], flow cytometry, etc.)
  • Experience with equipment operation and/or the flexibility and desire to learn operation of new equipment.

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 by March 20th, please visit: https://jobs.hr.wisc.edu/en-us/job/504627/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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