Director, Process Engineering & Scale Up

Position Overview

Nektar Therapeutics has an exciting opportunity for a Director, Process Engineering and Scale Up.

The 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. Manages 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. Is responsible for late-stage process development and process validation in accordance with regulatory guidance. Selects, develops, and evaluates personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Participates with other senior managers to establish strategic plans and objectives. Makes final decisions on administrative or operational matters and ensures objectives are achieved. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Manages a group of scientists and engineers with expertise in drug substance process development and manufacturing, including cell culture/fermentation, harvest, purification and PEG conjugation. Responsible for process characterization and scale up activities both internally at Nektar and at partner organizations. Facilitates drug substance technology transfer between process sciences organization and the manufacturing site to meet required project goals. Responsible to mitigate technical challenges as part of manufacturing. Interfaces with Nektar's core PEGylation technology for drug substance creation. Ensures budgets and schedules meet corporate requirements. 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. Directs technical project teams to provide innovative solutions to meet project deadlines. Works on complex issues where analysis of situations and data requires an in-depth knowledge of process engineering, factors influencing scale up/down of critical process parameters and pharmaceutical production equipment. Ensures budgets and schedules meet corporate requirements. Implements new process manufacturing and control technology. Develops supports and maintains development report writing systems, development reports, documents and data storage. Travels to contract management site or business partners, as required, both domestic and international up to 20%. Other duties as assigned.

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 13 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. Strong verbal and written communication skills are required. Must be goal-oriented, quality-conscientious, and customer-focused. Good compliance and safety practices are a must. Must be experienced in working in a team-focused environment. A proven track record in developing and managing process development organizations in both startup and commercial environments is a must. Must have a thorough working knowledge of FDA, ISO and cGMP requirements for areas of responsibilities. Project management experience is a plus. A proven ability to work within a budget and timeline and provide cost savings is required.

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.