Sr. External Manufacturing Manager

Location
San Francisco, CA, United States
Posted
Oct 06, 2018
Ref
3258-394-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

External Manufacturing Manager will work with CMC project leaders and Senior Management to provide oversight on all aspects of GMP manufacturing activities.

External Manufacturing Manager will work 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 adherence to project timelines and budget at CMO sites for uninterrupted supply of clinical trial material.

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. Travel to contract management site or business partners, as required, both domestic and international up to 50%. 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.

Bachelor's degree in a scientific discipline with minimum of 8 years in experience in the pharmaceutical industry. 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.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.