Description:
Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.
Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.
The Role:
- Authors and revises Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aids (JA)
- Performs daily review and final sign-off of executed cGMP documentation (BPRs, forms)
- Supervises general cleanroom housekeeping, including room and equipment cleaning(s), disposal of trash and recyclables, and adherence to 5S standards
- Trains, monitors, and mentors direct reports on biomanufacturing activities; Mentors staff regarding regulatory requirements and supports operators with deviation management
- Holds 1x1s with employees; Leads team meetings and/or training sessions. Acts as Subject Matter Expert (SME) on biomanufacturing activities
- Supervises completion of routine and preventive maintenance on biomanufacturing equipment; Supervises/executes equipment qualification/validation protocols, as required
- Supports deviation investigations and change control/protocol execution in a time sensitive fashion
- Drives and supports continuous process improvement initiatives.
- Other duties as assigned
The Candidate:
- Must have Masters Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 2 year of relevant experience OR
- Bachelors or Associates Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 4 years of relevant experience OR
- High School Diploma with a minimum of 6 years of relevant experience
- GMP experience required
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
- Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds is required