Drug Product Process Development Engineer

Drug Product Process Development Engineer

Role Summary

As a Drug Product Process Development Engineer, you will drive the design, development, and transfer of manufacturing technology into clinical and commercial operations. You will play a vital role in our research and development efforts to create high-value therapeutics by providing advanced engineering expertise in process design, characterization, scale-up, optimization, technology transfer, and validation.

Key Responsibilities

Technology Transfer & Scale-Up: Lead the introduction of new products and technologies from the laboratory to manufacturing at CDMO's.

Process Optimization: Develop process plans, design Design of Experiments (DOEs), and analyze complex data to manage studies and optimize manufacturing.

Equipment & Design: Establish product and process requirements for new equipment, and collaborate with designers to maintain, improve, or create new equipment.

Cross-Functional Collaboration: Partner with internal departments, contract manufacturers, and consultants to ensure processes align with product requirements and future manufacturing technology.

Problem Solving: Assist manufacturing operations with troubleshooting to improve product quality and achieve cost-effectiveness.

Documentation & Compliance: Prepare detailed reports, protocols, and Standard Operating Procedures (SOPs). Complete investigations, issue findings, and contribute to regulatory filings and reviews.

Required Skills & Qualifications

Strong analytical, critical thinking, and structured decision-making skills with sound technical judgment.

Hands-on experience with process validation.

Excellent written and oral communication, combined with strong documentation and record-keeping skills.

Ability to provide technical engineering support in a collaborative, team-oriented environment.

Preferred: Understanding of drug product filling operations, container closure system's (vial and pre-filled syringe), regulatory filings, ICH guidelines, process characterization and process performance qualification (PPQ)

Preferred: Understanding of Medical Device regulations, device design controls, design history files, and risk management standards.

Preferred: Experience with DOEs and statistical analysis.

Education & Experience

Bachelors degree in an Engineering discipline (equivalent experience may be considered).

5 years of industry work experience in the Medical Device or Biopharma sectors.

2 years of experience in a cGMP pharmaceutical manufacturing or similarly regulated environment.

Proven experience in pharmaceutical or Medical Device process/product development.

Additional Requirements

Travel: Up to 20% travel is required to contract manufacturers or business partners.

Additional Information

Nektar currently anticipates the base salary for the Senior Drug Product Process Engineer to range from $140,000 to $160,000 for candidates in the Bay Area and will depend, in part, on successful candidate location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan, depending in part on company and individual performance and at the Company's discretion. The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.

Qualifying employees are eligible to participate in benefit programs such as:

Health Insurance (Medical/Dental/Vision)

Disability Insurance

Holiday Pay

Paid Time Off (PTO)

401(k) Match

Employee Stock Purchase Plan

Wellness Programs

Parental Leave Benefits (in accordance with the terms of applicable plans)

For general information on company benefits, please go to https://www.nektar.com/careers.