Manager Manufacturing, New Product Introduction - Downstream
Amgen
Summary
In this vital role you will act as the Manager for the New Product Introduction (NPI) Team in GMP Drug Substance Supply. This position is within Amgen North Carolina (ANC) Manufacturing and GMP Supply - Manufacturing Support organization. ANC is a dynamic environment and an important supply facility for Amgen's pipeline products. The GMP DSS plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment platforms. This NPI 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
What you will do
- Directly manage a team of NPI leads responsible for introduction of new products and/or advanced technologies into the plant. Includes hiring, training, oversight, performance evaluations, and development.
- Proactively assess the NPI team capabilities to meet the evolving drug substance supply needs (ex. resources, platform technical understanding, cross-functional alignment).
- Lead team meetings and drive alignment in business processes across the team.
- Coordinate with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, Quality as well as Manufacturing for the introduction of new products, process changes and improvements 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 change controls are kept up to date and supporting staff with audit or regulatory response strategy.
- Interacts with management in planning, developing, and maintaining budget
- Assist in developing and maintaining department goals
- Interact with regulatory agencies as needed
- Responsible for engaging staff and building relationships of trust and respect while driving team performance and continuous improvement
- Responsible for selection, training, evaluation, staff relations and staff development
- Mentor and coach staff members to live by the Amgen Values
- Develop and implement trainings plans and programs, to ensure staff are prepared and compliant
- Other functional responsibilities may be assigned
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.
Basic Qualifications
- Doctorate degree OR Master's degree and 3 years of biotechnology or pharmaceutical manufacturing experience OR Bachelor's degree and 5 years of biotechnology or pharmaceutical manufacturing experience OR Associate's degree and 10 years of biotechnology or pharmaceutical manufacturing experience OR High school diploma / GED and 12 years of biotechnology or pharmaceutical manufacturing experience
- In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications
- 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
Requirements
- Doctorate degree OR Master's degree and 3 years of biotechnology or pharmaceutical manufacturing experience OR Bachelor's degree and 5 years of biotechnology or pharmaceutical manufacturing experience OR Associate's degree and 10 years of biotechnology or pharmaceutical manufacturing experience OR High school diploma / GED and 12 years of biotechnology or pharmaceutical manufacturing experience
- Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or 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
- Health insurance
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Retirement and savings plan
- Flexible spending accounts
- Discretionary annual bonus
- Stock-based long-term incentives
- Paid time off
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.