Manufacturing Programs Senior Manager NPI
Overview
Lead New Product Introduction initiatives at Amgen's Raleigh facility. Drive cross‑functional collaboration to introduce drug substance products while championing Lean Transformation and continuous improvement. This role blends technical expertise with leadership to shape the future of biomanufacturing.
What You'll Do5
- 1Act as NPM subject matter expert coordinating with Manufacturing Process Development Supply Chain Planning Facilities Engineering Quality to introduce new Drug Substance products using project management tools.
- 2Solve technical challenges rapidly and lead a team of NPI manufacturing specialists fostering a thriving culture.
- 3Ensure production documents are accurate and up to date while supporting troubleshooting and root cause analysis.
- 4Champion Lean Transformation and operational excellence initiatives tracking plant‑level progress.
- 5Develop and execute CAPA strategies to prevent error recurrence and support manufacturing in RCAs.
Requirements5
- 1Doctorate degree with 2 years biotechnology operations experience or Master’s degree plus 6 years operations experience.
- 2Minimum 2 years direct people management or leadership experience leading teams projects or allocating resources.
- 3Bachelor’s degree with 8 years operations experience preferred; associate’s degree with 10 years experience acceptable.
- 4Degree in Chemistry Biology Engineering or equivalent hands‑on biotechnology operations experience.
- 5Strong cross‑functional project management and meeting facilitation abilities with excellent technical writing skills.
Salary Insight
Salary not disclosed in listing
Location
Required Skills
Similar open positions
Explore active roles that match your skills and interests.
Bionova Scientific LLC
VerifiedSenior Manufacturing Associate, Upstream Bioprocessing
You will own complex upstream unit operations in a GMP cell culture environment, driving bioreactor runs from seed train to harvest at Bionova Scientific. You will serve as a subject matter expert and trainer for junior staff, leading troubleshooting and continuous improvement on the floor. Your work supports a rapidly growing CDMO backed by Asahi Kasei Group, where your technical judgment shapes batch execution and client outcomes. This role stands out because you will have minimal oversight, direct involvement in CAPA and investigations, and a voice in technology selection.
Resonetics
VerifiedSenior Director of NPI Engineering
You will lead end-to-end product transitions from development to scalable, compliant manufacturing at a global medical device manufacturer. You will own the NPI strategy, cross-functional execution with R&D, Quality, Regulatory, and Operations, and build resilient systems for volatile regulatory and supply chain conditions. This role blends strategic leadership with operational rigor, demanding expertise in FDA regulations, ISO 13485, and design controls. You will drive rapid launches while maintaining safety and compliance, and build a high-performing team capable of thriving under uncertainty.
K-Tek Resourcing LLC
VerifiedManufacturing Engineer, NPI & Process Improvement
Own the New Product Introduction (NPI) process for transition into manufacturing at a Boston-based medical device company. Design and build fixtures for sub-component testing, then develop and implement operational methods for sub-assembly production. Collaborate with cross-functional teams to drive continuous improvement and 8D problem solving. This role cuts production labor and material costs while improving efficiency and utilization. You'll work with NPI, 8D, and CAD tools in a fast-paced contract environment.
BCForward
VerifiedManufacturing Specialist, Pharmaceutical Operations
You will support manufacturing readiness, process improvements, and compliance in a regulated biologics environment at Hillsboro, OR. You own technical changes, deviations, and CAPA execution across a 10-month contract with a leading life sciences client. Collaborate with Manufacturing, Quality, and Engineering teams to drive process capability and reliability. This role offers direct impact on aseptic operations and root cause analysis in a fast-paced production setting.
Neurocrine Biosciences Inc.
VerifiedPrincipal Scientist Pharmaceutical Development Neurocrine Biosciences
Neurocrine Biosciences seeks a senior technical leader to drive CMC projects from discovery through commercialization. This role provides strategic scientific leadership in process development and manufacturability while collaborating with internal and external partners. The ideal candidate excels in parenteral drug product development and has extensive experience with regulatory compliance and cross-functional teamwork.
System One
VerifiedManufacturing Associate, Biopharmaceutical Manufacturing
Own biopharmaceutical manufacturing operations at a Novato site, applying mammalian cell culture and purification techniques to produce bulk drug substance. Collaborate with a cross-functional team in a cGMP environment to support process optimization and technology transfer. This contract role offers $28.00/hr plus shift differential, with a Sunday-Tuesday schedule and alternating Wednesdays, providing a unique work-life balance.