[Remote] Senior Drug Product Process Engineer
Note: The job is a remote job and is open to candidates in USA. Nektar Therapeutics is seeking a Senior Drug Product Process Engineer for their Process Development team. The role involves supporting drug product process development, ensuring regulatory compliance, and providing technical expertise for the organization to create high value therapeutics.
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 businesses 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
• Bachelor's degree in a scientific or engineering field
• Combination product experience is a plus
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)
Company Overview
• Nektar Therapeutics develops therapeutics based on its advanced polymer conjugate chemistry technology platform. It was founded in 1990, and is headquartered in San Francisco, California, USA, with a workforce of 51-200 employees. Its website is http://www.nektar.com.
Company H1B Sponsorship
• Nektar Therapeutics has a track record of offering H1B sponsorships, with 2 in 2025, 1 in 2024, 3 in 2023, 14 in 2022, 15 in 2021, 13 in 2020. Please note that this does not guarantee sponsorship for this specific role.
Apply Now
Apply Now
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 businesses 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
• Bachelor's degree in a scientific or engineering field
• Combination product experience is a plus
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)
Company Overview
• Nektar Therapeutics develops therapeutics based on its advanced polymer conjugate chemistry technology platform. It was founded in 1990, and is headquartered in San Francisco, California, USA, with a workforce of 51-200 employees. Its website is http://www.nektar.com.
Company H1B Sponsorship
• Nektar Therapeutics has a track record of offering H1B sponsorships, with 2 in 2025, 1 in 2024, 3 in 2023, 14 in 2022, 15 in 2021, 13 in 2020. Please note that this does not guarantee sponsorship for this specific role.
Apply Now
Apply Now