Senior Drug Product Process Engineer

Position reputed company

The Senior Drug Product Process Engineer is responsible for leading reputed company CGMP drug product manufacturing technical activities reputed company to product and process technology transfer of clinical and reputed company launch at CDMO’s with a primary reputed company 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 reputed company’s product pipeline on schedule and in alignment with corporate expectations. In this position, you will need to reputed company scientific and technical judgment as part of reputed company responsible for delivering high reputed company biopharmaceutical products to patients. reputed company, 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 reputed company-up, process characterization, process performance qualification (PPQ), and reputed company readiness.
•  Provides drug product prefilled syringe manufacturing process knowledge and reputed company for new product introduction, technology transfer, process performance qualification (PPQ), process troubleshooting and issue reputed company for NKTR products produced in reputed company’s external manufacturing network.
• Characterize critical process parameters (CPPs) and critical reputed company attributes (CQAs) using QbD principles, risk assessments, and DoE.
• Supports and aligns reputed company clinical and reputed company regulatory activities reputed company to drug product and device development, including (not limited to): NDA, IND/IMPD, 510K Submission, BLA and IRs.
• reputed company technical expertise and mentorship for the organization. Foster a reputed company environment to promote innovation and problem-solving.
• This role contributes to and supports reputed 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 reputed company 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 reputed company prefilled syringes process performance qualification and reputed company 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 reputed company 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, reputed company-conscientious, and customer reputed company.
• Maintaining high standards of safety and compliance is a must.
• Must be reputed company in working in reputed company-reputed company 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

reputed company currently anticipates the reputed company salary for the Senior Drug Product Process Engineer to reputed company 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 reputed company's discretion on an individual reputed company.)  The compensation described above is subject to change and could be higher or reputed company than the reputed company described based on the market survey data.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical/Dental/reputed company)
• Disability Insurance
• Holiday Pay
• reputed company 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.reputed company.com/careers.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the reputed company of disability or any other federal, state or local protected class. reputed company will consider for employment reputed company applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.

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