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External CMO Manager, Research and Process Develop

Job Req # 568646


Global Pharmaceutical Manufacturing Company is looking for:


POSITION: ?External CMO Manager, Research and Process Development(No Direct Reports)


LOCATION:? Caldwell, New Jersey


SALARY:? $125-145K


DEGREE:?? Required


EXPERIENCE:? 5+ Years R&D and Pharmaceutical Development Projects Leadership including Scaleup and Tech Transfer ? Must have experience in Parenterals with an added plus to people that have experience with injectable, semisolids, transdermals and/or inhaler


STATUS: Company NOT considering H1B, Visa, or EAD Candidates


RELOCATION:? Available


Here?s what the client is looking for:?? R&D/Scientific or Process Development background with minimum knowledge in Parenterals.? Anyone that has injectable, semisolid and transdermal experience is an added bonus. ?This person needs to R&D, Process Validation, Tech Transfers, and Scale-up.? This person will be working directly with CMOs


External Manager will work with work with cross functional stakeholders and Senior Management to provide oversight on all aspects of GMP manufacturing activities for several programs at contract manufacturing sites (CMO's). This includes ensuring adherence to project timelines and budget at CMO sites for uninterrupted supply products


Responsibilities:?
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise. Works in a cross-functional team consisting of internal and external partners to ensure effective application of process technologies at CMO sites. Facilitates technology transfer between organizations and sites to meet required project goals. Ensures timely routing and review of all master batch records and deviation reports. Coordinates Drug Substance and Drug Product manufacturing activities at CMOs; including, but not limited to: routing of contracts for approvals internally and externally, assisting with scheduling of process development activities and GMP manufacturing campaigns, direct shipment of samples and finished products between sites, track project timelines and action items. Ensure product integrity and company reputation by assisting in the monitoring of cGMP compliance at all times. Is responsible for issuing requests for proposals for manufacturing and analytical services per program requirements and negotiating CMO fees/payment schedules.


 

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