Senior Process Development Engineer - Upstream
Role Overview
In biologics process development, the Senior Process Development Engineer – Upstream works within a highly cross-functional team to advance our products from early to late-stage development. Responsibilities span upstream microbial activities from seed train through primary recovery with a focus on late-stage development.
Key Skills for This Role
Full Job Posting
Summary
In biologics process development, the Senior Process Development Engineer – Upstream works within a highly cross-functional team to advance our products from early to late-stage development. Responsibilities span upstream microbial activities from seed train through primary recovery with a focus on late-stage development.
Process Development
Design, execute, and optimize upstream microbial ( E. coli, P. pastoris, B. subtilis ) unit operations (e.g. seed train, production fermentation; centrifugation, cell lysis and depth filtration) to deliver scalable, high‑yield, high‑purity processes that meet target CQAs.
Process Transfer, Validation, and Technical Support
Provide on-site and remote support for manufacturing processes, addressing technical issues that arise during production.
Review and approve GMP documentation, support investigations by applying rigorous scientific principles and data analysis to solve complex process challenges.
Lead process changes and new process transfers from development to manufacturing; act as liaison between PD and Manufacturing
Cross‑Functional Collaboration & Program Support
Serve as the USP representative on CMC teams; integrate with Downstream, Analytical Development, Formulation, Quality, and Regulatory to align development plans, timelines, and deliverables.
Prepare and deliver technical presentations and updates to project leadership, governance, and external partners/CMOs.
Education or Degree Requirements
- A bachelor’s degree in an engineering discipline is required. Equivalent experience may be considered.
Professional Experience Requirements and Qualifications
- 8+ years of industry experience is required, including a minimum of 5 years work experience in a GMP, development, operational or manufacturing environment. Post-doctoral work may serve as experience.
- Demonstrated expertise in seed train and production fermentation, centrifugation, cell lysis and depth filtration from lab to pilot scale.
- Hands‑on with Sartorius systems and control software (e.g., DeltaV/ABB); proficiency in stainless steel fermentor and continuous flow centrifugation operations.
- Familiarity with cGMP expectations for clinical manufacturing and authoring/review of cGMP‑aligned documentation.
- Experience collaborating with Manufacturing, supporting engineering/clinical runs, and executing process transfers.
- Strong cross‑functional communication and stakeholder management in a matrixed environment; ability to present complex data clearly to technical and non‑technical audiences.
- Must possess excellent oral and written communication skills.
- Results oriented, organized, and thorough, with high standards for data integrity and safety.
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.
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.
About Nektar Therapeutics
Clinical-stage biopharmaceutical company developing immunomodulatory medicines for autoimmune, inflammatory, and cancer diseases.
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