Sr. Process Development Engineer (CMO Management)

San Francisco, CA, United States
Sep 04, 2019
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Designs, develops and transfers manufacturing technology into clinical and commercial operations.

Provides expertise in process development and engineering including design, characterization, scale-up, optimization, technology transfer and validation. Introduces new products and technology from the laboratory to manufacturing. Assists manufacturing operations in problem solving to achieve cost effectiveness and improved product quality. Establishes product and process requirements for new process equipment. Interfaces with various departments to ensure processes and designs are compatible for new product requirements and to establish future manufacturing technology. May provide oversight on all aspects of GMP manufacturing activities for several Biologics clinical programs at contract manufacturing sites (CMOs).

Uses professional concepts and company objectives to resolve complex issues in creative and effective ways. 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. Determines methods and procedures on new assignments. Leads projects and determines resources with senior management input. Assists in the determination of departmental objectives and their achievement. May represent the department on core teams and act as a Team Lead. May work in a cross-functional team consisting of internal and external partners to ensure effective application of process technologies at CMO sites. Builds executable cross functional plans for projects and may supervise staff on projects. May draft and review regulatory filing sections. Reviews reports and may approve reports. Plans and may oversee test plan strategy with all studies and protocols. Resolves most issues on studies and prepares complex reports. Prepares cross functional instructional SOP's and explores system level improvements. Develops process development plans for projects. Balances program team needs with corporate requirements and process requirements. Establishes equipment specifications and concepts. Provides process perspective to equipment design reviews. May provide guidance to technical staff. May coordinate 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.

A minimum of a Bachelors degree in an engineering discipline is required. Equivalent experience may be accepted. A minimum of 8 years industry work experience is required. Must have 5 years experience in a GMP research, development, operational or manufacturing pharmaceutical or other regulated environment. Must possess excellent technical judgment and use structured decision-making techniques. Must be a team player with excellent interpersonal skills. Project management skills are highly preferred. Excellent communication skills, both written and oral are required. Experience in late-stage development programs, pharmaceutical process commercialization and technology transfer is preferred. A working knowledge of regulatory requirements for pharmaceutical industry is required. Demonstrated technical writing skills in support of regulatory filings is a plus. Must have an ability to provide technical engineering support in a collaborative, team-oriented project environment. Must have extensive experience with DOE and statistical analysis. Good documentation and record keeping skills and attention to detail are essential. May require travel to contract management site or business partners, as required, both domestic and international up to 50%.

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.