Manager Manufacturing, New Product Introduction - Downstream

Amgen•Holly Springs, NC

About The Position

Amgen is seeking a Manager for the New Product Introduction (NPI) Team in GMP Drug Substance Supply, located at their North Carolina (ANC) Manufacturing and GMP Supply - Manufacturing Support organization. This role is within a dynamic environment at Amgen's newest and most advanced drug substance manufacturing plant, the FleX batch facility. This facility combines the latest single-use and traditional stainless steel technologies for flexible operations, integrating industry 4.0 capabilities and sustainability innovations to support Amgen's goal of being a carbon-neutral company by 2027. The NPI team serves as a key communication and technical interface between GMP manufacturing operations and various departments including Process Development, Drug Substance Technologies & Engineering, Supply Chain, Facilities & Engineering, and Quality. The GMP DSS plant manufactures drug substance for clinical trials and commercial supply.

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. Managerial experience may run concurrently with the required technical experience.

Nice To Haves

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

Responsibilities

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.