Description
Job Description - Senior Operations Role in Product ManufacturingThis highly sought after position reports directly to Vice President of Drug Substance Operations with the potential to become site-head. The primary function of this role is operations organization of Bioscience Laboratories to receive full facility licensure and specifically release of GXP material to CMC teams.
Responsibilities
-Oversight and completion/resolution of Manufacturing and Facilities documentation, including forms: BPR's and deviations/discrepancies/non-conformances/OOT's/audit observations.
-Oversight and organization of logistics of site-wide support for shipping/receiving and all transactions within SAP with the ability to provide support for additional sites.
-Ensure manufacturing support function responsible for production area cleaning, laboratory cleaning, autoclaving supplies, parts washing, integrity testing, and collecting routine environmental samples.
-Determine allocation of resources/sight governance process, in addition to maintenance of and performance against finite schedule.
Qualifications
- BA/BS or Masters in relevant scientific discipline
-Hands-on leadership in manufacturing in clinical and commercial setting
-QA related experience (work in MSAT, QA / Validation required)
- Drug substance experience
- 5 Years of hands on leadership in supervisory manufacturing experience (direct and indirect)
- Experience being involved with PAI / licensing a facility
If you are interested in a well-respected position with tremendous room for growth, please respond
To find out more about Real please visit www.realstaffing.com