Parenteral Scientist, Clinical Mfg

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.Job Summary:
This position is responsible for the start-up support of the Parenteral/Cytotoxic (high potency) GMP suite in Great Valley. Technical leadership and administrative support for Clinical manufacture of GMP products will be the primary focus of this position.Duties & Responsibilities:
1. Lead the start-up of parenteral/Cytotoxic GMP suite including:
a. PQ development and execution.
b. Training
c. Final readiness
d. Audit by agencies (US and Europe)
e. HES review
2. Perform and/or delegate operations required to manufacture, parenteral/Cytotoxic dosage forms such as scheduling, dispensing, processing, filling, sterilizing, and declaration into inventory.
3. Ensure manufacture follows cGMP requirements.
4. Coordinates with QC in-process testing, water sampling and testing, final release testing ,sterility testing, bioburden monitoring, and cleaning verification testing.
5. Upon receipt of a bulk manufacturing order, participate in a feasibility study to determine if quantifies and timelines can be met. Assure lead times for manual parenteral manufacture are reasonable.
6. Orders raw materials and ensures that materials needed for manufacturing, in-house and at subcontractors, are in stock and are released for use.
7. Create, review, and revise Batch Manufacturing Instructions as per formulation Transfer Reports and cGMP regulations.
8. Requests and reviews manufacturing batch records.
9. Reports to GMP Manager and QA any anomalies in the manufacturing process and initiates investigations into the anomalies.
10. Responds to QC manufacturing batch record observations.
11. Ensures that equipment to be used for manufacturing are maintained and cleaned.
12. Coordinates execution of equipment qualification..
13. Create, review, and revise SOPs relating to manufacturing procedures
14. Monitor validation batches, clinical supplies, and manufacturing at subcontractors.
15. Creates, reviews and revised justifications for purchase of equipment.
16. Creates, reviews, and revises User Requirements for equipment.
REQUIREMENTS
Education/Skills:
MS, or BS (with equivalent experience), in Pharmacy, Chemistry or closely related subjects. five to ten years relevant experience in parenteral field. Experience in handling of cytotoxic materials is preferred.
Knowledge of GLP, cGMP and CMC (IND, NDA, ANDA, and SNDA) submission requirements.
Experience with product development and pharmaceutical manufacturing processes.
Effective in communicating with peers, management and subordinate.
Effective in managing personnel and production schedules.
Experience in start-up of parenteral facility highly valued.