Senior Drug Product Process Engineer

Position Summary

The Senior Drug Product Process Engineer is responsible for leading all CGMP drug product manufacturing technical activities related to product and process technology transfer of clinical and commercial launch at CDMO’s with a primary focus on prefilled syringe manufacturing. This role drives end‑to‑end process development, technology transfer, and PPQ execution in alignment with regulatory expectations for parenteral products. Collaborate closely with CDMOs, CMC, CSM, QA, RA, and subject matter experts to advance the company’s product pipeline on schedule and in alignment with corporate expectations. In this position, you will need to provide scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role.

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 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.
• Combination product experience is a plus.

Education:

Bachelor’s degree in a scientific or engineering field.