Senior Associate, cGMP Biomanufacturing

at Catalent
Location Madison, Wisconsin
Date Posted August 12, 2020
Category Bioscience
Job Type Full-time
Address 726 Heartland Trail

Description

Position Overview: 

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love.  Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Job Description

The Senior Associate I, Biomanufacturing Downstream is responsible for current Good Manufacturing Practices (cGMP) production activities, including Downstream protein/small scale purification, and/or Fill/Finish.  This is a Sunday- Wednesday 6:00 am – 4:30 pm shift.

The Senior Associate I, Biomanufacturing Downstream position requires a variety of skills necessary for a cGMP Biomanufacturing environment. Independently perform biomanufacturing operations, while adhering to SOPs and working in a cGMP compliant environment.  Tasks include: operate biomanufacturing equipment, such as, chromatography skids, Normal Flow Filtration/Tangential Flow Filtration skids; Perform column and membrane adsorption chromatography as well as viral reduction/filtration steps; Perform Bulk Drug Substance filling operations; and successfully perform purification techniques/operations such as Chromatography, AEX Membrane, Tangential Flow Filtration (TFF), Viral Filtration (VF), and Bulk Drug Substance (BDS) filling.                            

In concert with Catalent’s Patient First philosophy, the biomanufacturing team executes and documents manufacturing activities at the highest caliber pursuant to our goal of delivering products and services of the highest quality to our customers in a timely manner.

The Role

  • Lead/co-lead cGMP Biomanufacturing production activities
  • Daily review of executed cGMP documentation (BPRs, forms)
  • Coordinate w/ Supervisor to prioritize and schedule activities to meet deadlines
  • Perform aseptic techniques within in a clean room environment
  • Execute and document cGMP Biomanufacturing activities
  • Operate cGMP Biomanufacturing equipment such as pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and BioSafety Cabinets (BSC) or Laminar Flow Hoods (LFH)

The Candidate

  • PhD. In Biotechnology, or related field, with no prior experience; or
  • M.S./M.A. in Biotechnology, or related field, with a typical minimum of 1 years’ experience; or
  • B.S./B.A. in Biotechnology, or related field, with a typical minimum of 3 years’ experience in related laboratory work

Experience:

  • Required
    • Clean room, aseptic technique, and/or general lab equipment experience
    • cGMP, Good Documentation Practices (GDP), Good Laboratory Practices (GLP) knowledge
    • Experience operating, maintaining and troubleshooting Biomanufacturing-related equipment (TFF, VF, BDS filling)
  • Preferred:
    • Experience with SUBs, SUMs, Unicorn and/or Delta V software(s)
    • Experience with Trackwise, Compliancewire or other electronic tracking software

Catalent’s standard leadership competencies that are used to interview and for Performance & Development

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Position Benefits

  • Fast tracked career growth, with annual performance review and feedback process
  • Competitive base salary with other compensation incentives including yearly incentive plan
  • Medical, Dental, Vision, and 401K are all offered on day one of employment
  • 19 days of Paid Time Off (PTO) + 7 paid holidays
  • Onsite gym, Catalent corporate discount perks, paid volunteer time off program and other benefits too numerous to mention!
  • Defined career path and annual performance review and feedback process

Click here to learn more & apply today!

Drop files here browse files ...
Resume and/or Cover Letter