Description
Summary - Senior Operations Role in Product ManufacturingThis highly sought after position reports directly to the Vice President of Drug Substance Operations with the potential to become Head of Site. The primary function of this role is operations organization of Bioscience Laboratories to receive full facility licensure and specifically the 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
This position could be a great career move for the right candidate.
To find out more about Real please visit www.realstaffing.com