Pearl River, New York
about 1 month ago
Senior Manager-Outsourcing and Operations
Pearl River, NY
Job Id: 10191
Are you looking to make a career change to a stable company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision insurance, 401K, paid PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you.
- Responsible to assist in managing the outsourcing activities related to GXP at the manufacturing, testing, shipping, storage, and clinical research organizations from preclinical to clinical stages of product development.
- Assist in the evaluation of candidates of contract organizations for the selection by upper management through the performance of on-site technical evaluations, and participation of qualifying audits of contract organizations
- Working together with Quality, review and approve documents related to regulatory submission such as master batch records, executed batch records, protocols, reports, OOS investigations, and deviations from the contract organizations.
- Working together with Finance and Project Management, manage budget and approve invoices issued from the contract organizations.
- Provide oversight when needed for the operational activities related to receiving, shipping, monitoring, calibration, and equipment maintenance
- Strong background in vaccine/biologic manufacture and the GXP requirements.
- Experience in the execution of process development (upstream or downstream), technology transfer, method qualification, method validation, and process validation are required.
- Demonstrated technical skills in resolving issues during technology or method transfer.
- Knowledge of the common analytical methods such SDS-PAGE, Western Blot, sterility, endotoxin, bioburden, etc. is preferred
- Experience in CMC review or CMC writeup will be beneficial.
- Up to 25% of business travel may be required for this position.
- The incumbent must be comfortable in the exposure to recombinant viruses
- Medical Insurance
- Dental Insurance
- Vision Insurance
Ask for: Aarti Manchanda
Ajulia Executive Search is a New Jersey based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements.