Manager, External Manufacturing (Biologics)

Location
San Francisco, CA, United States
Posted
Jul 11, 2021
Ref
5341-394-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Manager, External Manufacturing to join their team.

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 adherence to project timelines and budget at CMO sites for uninterrupted supply of clinical trial material.

Responsibilities:

The ideal candidate will work on issues of diverse to complex scope where analysis of situation or data requires evaluation of a variety of factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Implements policies when selecting methods, techniques, and evaluation criteria for obtaining results. Assures adherence to budgets, schedule, work plans, and performance requirements. 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, directing shipment of samples and finished products between sites, tracking project timelines and action items. Will also be responsible for general oversight of the supply chain and material management activities. Travels to contract management site or business partners, as required, both domestic and international approximately 30%. Candidate will be instrumental in maintain 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.

Requirements:

Bachelor's degree in a scientific discipline with minimum of 8+ years of 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.