|at ( view profile)|
|Date Posted||August 29, 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 Specialist, cGMP Biomanufacturing is responsible for current Good Manufacturing Practices cGMP) production activities, including Master/Working Cell Bank production, Upstream cell culture, Downstream protein/mRNA purification, and/or Fill/Finish. This is a Sunday – Wednesday 6:00 am – 4:30 pm shift.
The Specialist, cGMP Biomanufacturing 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. Analyze and interpret results in written and oral format. Other duties will include Batch Production Record/data review, drafting technical documents protocols and reports, training/mentorship of (including contributions to performance management) staff and driving process improvement initiatives. The position is expected to follow detailed instructions and established procedures with minimal supervision.
In concert with Catalent’s Patient First philosophy, the Specialist, cGMP Biomanufacturing position delivers timely final quality product that improves patient lives by producing innovative medical solutions.
- Lead cGMP Biomanufacturing production activities
- Daily review and final sign-off 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 analytical equipment as applicable.
- PhD in Biotechnology, or related field, with a typical minimum of 2 years’ experience; or
- M.S./M.A. in Biotechnology, or related field, with a typical minimum of 3 years’ experience; or
- B.S./B.A. in Biotechnology, or related field, with a typical minimum of 5 years’ experience in related laboratory work; or
- Associates Degree/Certificate/Diploma in Biotechnology, or related field with a typical minimum of 6 years’ experience
- High School Diploma or equivalent with a typical minimum of 7 years’ experience in related laboratory work.
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
- 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