Process Development Engineer III

Location
Huntsville, AL, United States
Posted
Oct 03, 2019
Ref
5003-394-2019
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Supports the design, development and transfer of manufacturing technology into clinical and commercial operations.

Position Overview

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. Provides support for GMP manufacturing activities for Biologics clinical programs at Contract Manufacturing sites (CMOs). This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Description

Works on problems of diverse scope where analysis of situations or data requires evaluation of variable factors. Demonstrates sound judgment in selecting methods and techniques for obtaining solutions; may select methods, techniques and evaluation criteria for obtaining results. Networks with senior internal and external contacts in own area of expertise. Uses skills as a seasoned, experienced professional with a full understanding of industry practices and company policies and procedures. Resolves a wide range of issues in imaginative as well as practical ways. Works cross functionally with contract manufacturers and consultants. May require travel to CMOs, both domestic and international, up to 25%. Identifies the majority of required studies and provides moderate to complex analysis. Resolves moderate to complex issues with studies. Prepares detailed reports, protocols and department instructional SOP's. Completes moderate investigations and issues findings and resolves moderate issues. Contributes and applies industry work practices and standards to efforts. Contributes to regulatory filings and reviews. Designs DOE for processes and analyzes complex data. Manages studies. Maintains equipment and interacts with designers to improve equipment or partners to design new equipment. May develop process development plans for projects. May lead specific projects with management input.

A minimum of a Bachelor's degree in an engineering discipline is required. Equivalent experience may be accepted. A minimum of 7 years industry work experience in Biopharma is required. Must have 4 years experience in a cGMP biologics manufacturing or other regulated environment. Pharmaceutical process or Biologics process development experience is a must. Must possess sound technical judgment and use structured decision-making techniques. Experience with PEGylated proteins or other polymer conjugated proteins is a plus. Must demonstrate the ability to think critically and analytically. Excellent oral and written communication skills are a must. Excellent computer skills are required. Must have an ability to provide technical engineering support in a collaborative, team-oriented project environment. Experience with process characterization including DOE and statistical analysis is a plus. Good documentation and record keeping skills and attention to detail are essential.

Employees must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job function. Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees must have 20/20 vision (with/without corrective lenses). Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function. Huntsville, AL only: Employee must be able to pass drug screening for employment consideration.

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.