Manager Manufacturing, New Product Introduction - Downstream

Amgen; Holly Springs (NC); Hybrid; USD 180,000 - 230,000; Full time

Job summary

Amgen NC Manufacturing – New Product Introduction (NPI) Downstream seeks a Manager to lead the NPI team in GMP Drug Substance operations. Based in Holly Springs, you will drive product introductions, lead resource planning, and partner across PD, Supply Chain, Quality, and Facilities to deliver new products and process improvements.

You will mentor staff, implement Lean/OE, ensure inspection readiness, and collaborate with Regulatory and Quality to maintain change controls and regulatory

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.
• Specialized leadership and team-building experience in a biopharma setting will be highly regarded.

Responsibilities

• Directly manage a team of NPI leads responsible for introduction of new products and/or advanced technologies into the plant.
• Assess team capabilities to meet evolving drug substance supply needs (resources, platform knowledge, 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 and 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.

Skills

People management

Project management

Cross-functional collaboration

Lean manufacturing

GMP/NPI experience

Technical communication

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma / GED

Tools

PAS X

Werum software

Job description

How MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in‑class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon‑neutral company by 2027.

Manager Manufacturing, New Product Introduction - Downstream

What You Will Do

Let’s do this. Let’s change the world. 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.

• 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

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.