Manager - New Product Introduction (NPI) and Manufacturing Execution System (MES)
Amgen
Summary
In this vital role you will act as the Upstream Manager for the New Product Introduction (NPI) and Manufacturing Execution Systems (MES) Team in B23 GMP Drug Substance Supply. This position is within Amgen Thousand Oaks (ATO) Manufacturing and Clinical Supply - Manufacturing Systems organization. ATO B23 is a dynamic environment and an important launch point for Amgen’s pipeline products. The GMP DSS plant manufactures drug substance for clinical trials through commercial production using both stainless steel and single-use equipment platforms. This NPI/MES team is a key communication and technical interface between the GMP manufacturing operations teams in the plant and Process Development, Drug Substance Technologies & Engineering, Supply Chain, Facilities & Engineering, and Quality.
Job description
Responsibilities
- Directly manage a team of Upstream NPI Specialists and MES Sr. Associates responsible for introduction of new products and/or advanced technologies into the plant, as well as Electronic Batch Record (EBR) development and management. Includes hiring, training, oversight, performance evaluations, and development.
- Proactively assess team capabilities to meet the evolving drug substance clinical/commercial supply needs (ex. resources, platform technical understanding, cross-functional alignment).
- Lead upstream area team meetings and drive alignment in business processes across the team.
- Coordinate with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, Quality, MES network, as well as Manufacturing for the introduction of new products, new/revised electronic batch records, and/or advanced technologies into the plant.
- Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
- Collaborate with Regulatory and Quality partners to ensure compliance of team change control records/documents and respond to regulatory questions and/or audit findings.
- Drive a culture of inspection readiness across the team by ensuring NPI and MES playbooks are kept up to date and supporting staff with audit or regulatory response strategy.
Requirements
- Doctorate degree OR Master’s degree and 3 years of biotechnology operations experience OR Bachelor’s degree and 5 years of biotechnology operations experience OR Associate’s degree and 10 years of biotechnology operations experience
- Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
- Degree in Chemical Engineering, Industrial Engineering, Biology or Biochemistry
- Experience leading/managing a team of direct reports
- Experience with PAS X, Werum software
- Experience in GMP operations, including New Product Introduction (NPI)
- Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
- Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
- Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
- Ability to coach, mentor and/or cross train colleagues within core technical areas
- Background in lean manufacturing methodologies and operational excellence
- Experience in cross functional Project Management
Benefits
- Retirement and savings plan
- Group medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Time-off plans
- Flexible work models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.