|at ( view profile)|
|Date Posted||May 28, 2019|
|Address||726 Heartland Trail|
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
The Senior Associate, Biomanufacturing position will lead/co-lead current good manufacturing practices (cGMP) production activities. Duties will include batch production record/data review, drafting technical documents protocols and reports and driving process improvement initiatives. The Senior Associate, Biomanufacturing is expected to follow detailed instructions and established procedures with minimal supervision; performing aseptic techniques within a clean room environment.
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.
- Coordinates with Supervisor to prioritize and schedule activities to meet established deadlines.
- Operates and troubleshoots 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).
- Routinely drafts and revises Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aids (JA).
- Leads deviation investigations and change control/protocol execution within established timelines.
- Performs processes of small and large scale cell culture production of mammalian cell lines, including cell counting, cell passaging and culture metabolite analysis.
- M.S./M.A. in Biotechnology, or related field, with no prior experience; or B.S./B.A. in Biotechnology, or related field, with minimum of 3 years’ experience in related laboratory work; or Associates Degree/Certificate/Diploma in laboratory science with minimum of 4 years’ experience in related laboratory work or High School Diploma or equivalent with a minimum of 6 years’ experience in related laboratory work.
- Clean room, aseptic technique, and/or general lab equipment experience required.
- Experience operating, maintaining and troubleshooting Biomanufacturing equipment required.
- Experience with SUBs, SUMs, Unicorn and/or Delta V software(s) preferred.
- Experience with Trackwise, Compliancewire or other electronic tracking software preferred.
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
- Competitive base salary with other compensation incentives
- 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, tuition reimbursement, discount corporate perks and other benefits too numerous to list!
- Defined career path and annual performance review and feedback process