$100K - $150K(Ladders Estimates)
The Manager, External Manufacturing works with CMC project leaders and Senior Management to provide oversight on all aspects of GMP manufacturing activities for several Biologics clinical programs at contract manufacturing sites (CMO's).
This includes ensuring adherance to project timelines and budget at CMO sites for unintrupted supply of clinical trial material. Works in a cross-functional team consisting of internal and external partners to ensure effective application of process technologies at CMO sites. Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as advisor to subordinates(s) to meet schedules and/or resolve technical problems. Develops and administers schedules, performance requirements; may have budget responsibilities. Networks with key contacts outside own area of expertise. 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, directing shipment of samples and finished products between sites, tracking project timelines, person-in-plant and action items. Travels to contract management site or business partners, as required, both domestic and international up to 50%. Ensures product integrity and company reputation by assisting in the monitoring of cGMP compliance at all times. Conducts regular project meetings with CMOs. Is responsible for issuing requests for proposals for manufacturing and analytical services per program requirements and negotiating CMO fees/payment schedules.
Bachelor's degree in a scientific discipline with minimum of 8+ years of related experience in the pharmaceutical industry and 5+ years of supervisory or management experience. Expertise in biopharmaceutical process development, GMP manufacturing with exposure to external partnership management is required. Frequent domestic and international travel required. Prior experience with technology transfer and providing oversight to CMOs desired. Excellent written and verbal communications and teamwork skills are essential. Must be goal oriented, quality conscientious, and customer focused. Project management experience is a plus. Performance of tasks essential to job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employee may be required to enroll in a medical surveillance program based on potential exposure to certain health hazards encountered as a result of their job function. Must be able to travel up to 50%.
Valid Through: 2019-9-20