Position Overview

Nektar has an exciting opportunity for a Senior Process Development Engineer on the Process Development team.

Summary

Works within a highly cross-functional team in biologics process development to advance products from early- to late-stage development. Supports downstream purification/PEGylation/formulation with a focus on late-stage development.

Essential Duties and Responsibilities

Process Development

Designs, executes, and optimizes downstream purification unit operations, including Refold, Clarification/Depth Filtration, IEX, HIC chromatography, and TFF/crossflow, to deliver scalable, high-yield, high-purity processes that meet target CQAs.
Process Transfer, Validation, and Technical Support
Provides on-site and remote support for manufacturing processes, addressing technical issues that arise during production.
Reviews and approves GMP documentation, supports investigations by applying rigorous scientific principles and data analysis to solve complex process challenges.
Leads process changes and new process transfers from development to manufacturing; acts as a liaison between PD and Manufacturing.

Cross Functional Collaboration & Program Support

Serves as the DSP representative on CMC teams; integrates with Upstream, Analytical Development, Formulation, Quality, and Regulatory to align development plans, timelines, and deliverables.
Prepares and delivers technical presentations and updates to project leadership, governance, and external partners/CMOs.

Additional Qualifications

Demonstrated expertise in protein chromatography (IEX, HIC), depth filtration, and TFF/crossflow from lab to pilot scale. Conjugation expertise is a plus.
Experience operating ÄKTA systems and control software (e.g., UNICORN), including proficiency in column packing/unpacking and membrane operations.
Familiarity with cGMP expectations for clinical manufacturing and authoring and reviewing cGMP-aligned documentation.
Experience collaborating with manufacturing, supporting engineering and clinical runs, and executing process transfers.
Strong cross-functional communication and stakeholder management in a matrixed environment, with the ability to present complex data clearly to technical and non-technical audiences.
Excellent oral and written communication skills.
Strong attention to data integrity and safety; results-oriented, organized, and thorough.

Education or Degree Requirements

A bachelor’s degree in an engineering discipline is required. Equivalent experience may be considered.

Minimum Professional Experience

8 years of industry experience is required, including 5 years in GMP research, development, operations, manufacturing, pharmaceuticals, or another regulated environment.
Postdoctoral work may be considered as experience.

Additional Requirements

May require up to 50% domestic and international travel to contract manufacturing sites or business partners.

Additional Information

Nektar currently anticipates the base salary for the Senior Drug Product Process Engineer to range from $170,000 to $190,000 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.