Executive Director, Process Engineering & Scale Up

Company: Nektar Therapeutics

Since its inception, Nektar has led with scientific ingenuity, unwavering resilience and a bold commitment to improving patients’ lives. We have built expertise spanning foundational scientific research, cutting-edge therapeutic discovery, clinical development, strategic partnerships and commercialization – all in pursuit of opportunities to improve outcomes for people with immune-mediated disease.

Through the years, we have developed a proven track record of translating groundbreaking research into innovative therapies in partnership with leading pharmaceutical companies. We remain focused on advancing scientific discoveries into safer, more effective treatments for people living with autoimmune diseases and inflammatory conditions.

Job Summary

The Executive Director, Process Engineering and Scale Up is responsible for process characterization, scale up, technology transfer and providing technical oversight on all aspects of GMP manufacturing activities at manufacturing sites, for either biologics or synthetics as the case might be.

• Leads the development, implementation, and plant support of production processes, control methods and equipment to achieve stage appropriate production of clinical trial material and commercial product.
• Plans and implements scale up and tech transfer strategies for the development of new processes, while establishing operating equipment specifications, cost effective improvement of manufacturing techniques, particularly for drug substance.
• Acts as a liaison with Process Sciences and Manufacturing to ensure processes and designs meet the needs of Nektar development teams.
• Works with Manufacturing and Quality Assurance in investigating batch record deviations to determine assignable causes and recommend corrective action.
• Responsible for late-stage process development and process validation in accordance with regulatory guidance.

Essential Duties and Responsibilities

This position is responsible for process characterization and scale up activities both internally at Nektar and at partner organizations.

• Builds, directs and maintains team(s) responsible for process development, scale up, and tech transfer of drug substance and reagents under Good Manufacturing Practices (cGMP) in support of Nektar proprietary drug development.
• Provides technical and managerial supervision of Process Engineering and Scale Up function to ensure development and production objectives are achieved.
• Plans and implements the commercial supply chain strategy, and the associated process development and tech transfer, to establish cost-effective commercial manufacturing capabilities within Nektar and with selected CMOs.
• Is responsible for the late-stage process development and validation of commercial processes.
• Engages in regulatory filings and agency interactions, including responsibility for relevant IND, NDA or BLA and other marketing application sections. Ensures the cost effective application of process technologies across internal development and partner projects.
• Travels to contract management site or business partners, as required, both domestic and international up to 20%. Other duties as assigned.

Additional Qualifications and Experience

• A minimum of a Bachelors degree in a scientific or engineering discipline is required. An advanced degree is preferred. Equivalent experience may be accepted.
• A minimum of 15 years experience in the pharmaceutical or other related industry is required. A minimum of 10 years previous management experience, preferably in a process development FDA regulated environment, is required.
• Must have experience within R&D and/or process development that includes pilot plant, scale up and commercial manufacturing. Must have experience in technology transfer from development into a pharmaceutical production operation.
• Must have a thorough working knowledge of FDA, ISO and cGMP requirements for areas of responsibilities.

Additional Information

Nektar Therapeutics (Nektar) currently anticipates the base salary for the Executive Director, Process Engineering & Scale Up to range from $250,000 to $375,000 for candidates depending, in part, on successful candidate's 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 on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on market survey data.

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

• Health Insurance (Medical / Dental / Vision)
• Disability, Life & Long - Term Care Insurance
• Holiday Pay
• Paid-Time Off (PTO)
• 401(k) Plan Match
• Employee Stock Purchase Plan
• Wellness Programs
• Parental Leave Benefits (in accordance with the terms of the applicable plans)

For general information on company benefits, please go to Nektar Careers.