Senior Drug Product Process Engineer

Nektar Therapeutics; United States; On-site; USD 175,000 - 190,000; Full time

Benefits offered by this job

Health Insurance (Medical/Dental/Vision)

Disability Insurance

Paid Time Off (PTO)

401(k) Match

Employee Stock Purchase Plan

Wellness Programs

Parental Leave Benefits

Job summary

A biotechnology company is seeking a Senior Drug Product Process Engineer to lead drug product process development and commercialization efforts. The ideal candidate will have over 8 years' experience in the medical device and pharmaceutical industries, particularly with prefilled syringes and aseptic processing. Responsibilities include ensuring compliance with budgets and timelines, providing mentorship, and supporting regulatory activities. This position offers a competitive salary within the range of $175,000 to $190,000 and includes benefits such as health insurance and a 401(k) match.

Qualifications

• 8+ years of experience in the medical device and/or pharmaceutical industries.
• In-depth knowledge of aseptic processing and fill-finish operations.
• Experience with technology transfer into pharmaceutical production.

Responsibilities

• Support drug product process development and commercialization.
• Ensure adherence to budgets, schedules, and performance requirements.
• Provide technical expertise and mentorship for the organization.

Skills

Experience in medical device and pharmaceutical industries

Knowledge of aseptic processing

Strong communication skills

Goal-oriented and customer focused

Team-focused environment work experience

Education

Bachelor’s degree in a scientific or engineering field

Job description

Essential Duties and Responsibilities

• Support phase-appropriate strategies for drug product process development, process transfer and scale-up, process characterization, process performance qualification (PPQ), and commercial readiness.
• Provides drug product prefilled syringe manufacturing process knowledge and oversight for new product introduction, technology transfer, process performance qualification (PPQ), process troubleshooting and issue resolution for NKTR products produced in the company’s external manufacturing network.
• Characterize critical process parameters (CPPs) and critical quality attributes (CQAs) using QbD principles, risk assessments, and DoE.
• Supports and aligns all clinical and commercial regulatory activities related to drug product and device development, including (not limited to): NDA, IND/IMPD, 510K Submission, BLA and IRs.
• Provide technical expertise and mentorship for the organization. Foster a collaborative environment to promote innovation and problem-solving.
• This role contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
• Establishes and assures adherence to budgets, schedules, work plans and performance requirements.
• Manage project workloads to provide innovative technical solutions to meet project deadlines.
• Ensures budgets, schedules and performance requirements are met.
• Travel to contract manufacturers or business partners, as required, up to 20%

Skills

• 8+ years of experience in the medical device and / or pharmaceutical industries. Must have 5 years experience in a cGMP pharmaceutical manufacturing or other regulated environment
• Must have experience within prefilled syringes process performance qualification and commercial manufacturing.
• Requires in‑depth knowledge of aseptic processing, fill‑finish operations, and PFS container‑closure systems, along with proven experience supporting GMP manufacturing and validation at clinical and commercial scales.
• 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.
• Maintaining high standards of safety and compliance is a must.
• Must be experienced in working in a team-focused environment.
• Must have a thorough working knowledge of FDA, ISO and cGMP requirements for areas of responsibilities.
• Combination product experience is a plus.

Education

Bachelor’s degree in a scientific or engineering field.

Additional Information

Nektar currently anticipates the base salary for the Senior Drug Product Process Engineer to range from $175,000 to $190,000 for candidates in the Bay Area and will depend, 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 the market survey data.

Benefits

• 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)

Equal Employment Opportunity

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.