Specialist Manufacturing New Product Introduction Job at Amgen (Holly Springs)

Supply Chain Specialist - New Product Introduction

At Bombardier, we design, build and maintain the world’s peak-performing aircraf...

Location

Canada , Dorval, Québec

Salary:

Not provided

Bombardier

Expiration Date

Until further notice

Requirements

Bachelor’s degree in business administration, engineering, project management or equivalent
Seven (7) to ten (10) years of experience in the aerospace industry and/or manufacturing environment and/or program management, in a commercial role, an asset
Experience in change management
Technical knowledge or experience in managing complex products
Strong leadership & analytical skills
Detailed oriented, focused and committed to meeting deadlines
Good communication skills (French & English)

Job Responsibility

Coordinate and execute Supplier’s strategies related to aircraft change management
Be responsible for all procurement related activities for specific commodities related to change management
Act as a project manager to ensure all procurement related activities are executed as per plan
Actively participate and represent Procurement within the various Integrated Work Teams (IWT)
Track supplier changes through the management process up to the point of implementation
Develop negotiation business strategies, lead/support contractual negotiations, resulting from product changes, with external suppliers
Ensure that correct project tracking and visibility are provided by the suppliers for Procurement and other business unit functions
Support, where applicable, the Procurement commodity teams in establishing sourcing strategies and draft commercial agreements with the suppliers
Coordinate the Procurement Agents activities in relation to the balanced scorecard objectives, the master plans and the detailed plans

What we offer

Insurance plans (Dental, medical, life insurance, disability, and more)
Competitive base salary
Retirement savings plan
Employee Assistance Program
Tele Health Program

Fulltime

Specialist Manufacturing: NPI, Process Owner

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of biotechnology operations experience
Associate’s degree & 8 years of biotechnology operations experience
Bachelor’s degree and 4 years of biotechnology operations experience
Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
Doctorate degree
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Downstream GMP manufacturing operations
Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

Job Responsibility

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of downstream unit operations
Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some downstream process unit operations
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
Downstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs
Support CAPA development to prevent error recurrence
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
Responds to regulatory questions and/or audit findings
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Specialist Manufacturing: NPI, Upstream Process Owner

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of biotechnology operations experience
Associate’s degree & 8 years of biotechnology operations experience
Bachelor’s degree and 4 years of biotechnology operations experience
Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
Doctorate degree
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Upstream GMP manufacturing operations
Strong technical knowledge of Upstream drug substance processing (media preparation, cell culture, harvest) and a broad understanding of related disciplinary areas in bioprocessing
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

Job Responsibility

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of upstream unit operations
Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some upstream process unit operations
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
Upstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs
Support CAPA development to prevent error recurrence
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
Responds to regulatory questions and/or audit findings
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Specialist Contract Development & Manufacturing

The Specialist Contract Development & Manufacturing at Amgen provides oversight ...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s in Business Administration, Engineering or Science-related field
5+ years of experience in protein, API, DS, DP or packaging manufacturing environment
5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
2+ years of project management experience leading multi-functional and/or multi-location team
1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products

Job Responsibility

Project Management and Technology transfers: The role involves leading and managing new product introductions (NPI) and technology transfers to external (third party) manufacturing organisations
Follow-up and track activities in a department-wide project from conception to implementation and close-out
Manage timeline and highlight risks of transfer team activities
coordinate risk management activities as part of transfer
provide escalation to the right level
Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting
contract inputs and requirements, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc
Own Deviations (Major/Minor)
Maintain and monitor systems to ensure all deviations received are appropriately investigated and concluded per the company's quality standards and procedures
Optimise deviations management, corrective and preventive actions effectiveness to prevent reoccurring events

What we offer

Be part of a global biotechnology leader known for scientific innovation and patient impact
Collaborate with international teams and gain exposure to world-class manufacturing and technology practices
Work in a growth-focused environment with access to professional development programs and cross-functional learning
Hybrid work model and inclusive culture that values well-being, diversity, and work-life balance

Specialist – QA Technical Support NPI

The Quality Assurance Technical Support Specialist NPI (New Product Introduction...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

University degree in a Science-related discipline
Minimum of 7 years’ relevant experience in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections
Experience working in aseptic operations, relating to vial and syringe filling
Understanding of principles of Validation and New Product Introduction
Proven experience in Quality Systems (change control, non-conformance, corrective and preventative actions)
Strong organizational skills with the ability to manage tasks through to completion
Ability to work independently and remotely with minimum direct supervision
Strong critical thinking and problem-solving abilities
Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration

Job Responsibility

Provide overall quality direction and oversight for key functional areas (i.e. PD, Validation and Operations), ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations
Serve as the QA Lead for technology transfer and NPI activities for Aseptic product, providing quality oversight throughout process validation and product lifecycle introduction
Serve as the QA point of contact and decision-maker during validation execution, ensuring adherence to regulatory and internal standards
Lead QA review and approval of technology transfer and validation documentation including process descriptions, Validation Plans, protocols, validation reports, and risk assessments
Lead QA review and approval of SAP BOMs, MBRs and recipes
Partner cross-functionally with PD, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and site quality requirements
Provide quality direction and input for Change Controls, CAPAs, and Deviation Investigations
Support inspection readiness and regulatory audits, representing QA for validation and NPI areas
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Perform all activities in compliance with Amgen safety standards and SOPs

What we offer

Competitive salary structure
Generous Total Rewards Plan for staff and eligible dependents
Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance
Discretionary annual bonus program
Exceptional learning, development and career advancement opportunities

Fulltime

New

Operations Project/Program Manager

Drive Innovation as our Next Operations Project/Program Manager (Electronics Man...

Location

United States , Dayton

Salary:

99600.00 - 137000.00 USD / Year

Trimble Inc.

Expiration Date

Until further notice

Requirements

5+ years of success leading program management within a manufacturing or product development environment
Bachelor’s degree in Engineering, Operations, or a related technical field, or equivalent combination of education and experience
Deep understanding of manufacturing operations, including MRP/ERP systems, material planning, and production scheduling
Proven ability to guide cross-functional teams and deliver complex projects on time and within budget
Excellent communication skills, capable of engaging both technical teams and global stakeholders effectively
Experience with industrial or commercial electronic products or comparable complex electromechanical systems

Job Responsibility

Lead the full lifecycle of complex programs from concept through launch and sustaining production for cutting-edge electronics
Spearhead New Product Introduction (NPI) projects, ensuring robust transitions from design to manufacturing through expert risk mitigation
Empower and manage a dedicated team of material specialists to maintain stable procurement and optimize global supplier networks
Drive continuous improvement and value engineering, owning product lifecycle management to ensure top-tier quality and performance
Collaborate as a key strategic partner with engineering, finance, and global manufacturing teams to meet impactful program commitments
Track and report program status, key milestones, and risks to internal and external stakeholders

What we offer

Medical
Dental
Vision
Life
Disability
Time off plans
Retirement plans
Tax savings plans for health, dependent care and commuter expenses
Paid Parental Leave
Employee Stock Purchase Plan

Fulltime

Supply Chain Specialist - New Product Introduction

At Bombardier, we design, build and maintain the world’s peak-performing aircraf...

Location

Canada , Dorval

Salary:

Not provided

Bombardier

Expiration Date

Until further notice

Requirements

Bachelor’s degree in business administration, engineering, project management or equivalent
seven (7) to ten (10) years of experience in the aerospace industry and/or manufacturing environment and/or program management, in a commercial role
experience in change management
technical knowledge or experience in managing complex products
strong leadership & analytical skills
detailed oriented, focused and committed to meeting deadlines
good communication skills (French & English)

Job Responsibility

Coordinate and execute Supplier’s strategies related to aircraft change management
Be responsible for all procurement related activities for specific commodities related to change management
Act as a project manager to ensure all procurement related activities are executed as per plan
Actively participate and represent Procurement within the various Integrated Work Teams (IWT)
Track supplier changes through the management process up to the point of implementation
Develop negotiation business strategies, lead/support contractual negotiations, resulting from product changes, with external suppliers
Ensure that correct project tracking and visibility are provided by the suppliers for Procurement and other business unit functions
Support, where applicable, the Procurement commodity teams in establishing sourcing strategies and draft commercial agreements with the suppliers
Coordinate the Procurement Agents activities in relation to the balanced scorecard objectives, the master plans and the detailed plans

What we offer

Insurance plans (Dental, medical, life insurance, disability, and more)
Competitive base salary
Retirement savings plan
Employee Assistance Program
Tele Health Program

Fulltime

New

Supply Chain Specialist - New Product Introduction

At Bombardier, we design, build and maintain the world’s peak-performing aircraf...

Location

Canada , Dorval

Salary:

Not provided

Bombardier

Expiration Date

Until further notice

Requirements

Bachelor’s degree in business administration, engineering, project management or equivalent
Seven (7) to ten (10) years of experience in the aerospace industry and/or manufacturing environment and/or program management, in a commercial role, an asset
Experience in change management
Technical knowledge or experience in managing complex products
Strong leadership & analytical skills
Detailed oriented, focused and committed to meeting deadlines
Good communication skills (French & English)

Job Responsibility

Be responsible for a specific Program Change Request (PCR) portfolio to ensure readiness of the supply chain and work in close collaboration with the strategic Procurement teams, Programs and Engineering
Act as the subject matter expert with regards to Integrated Work Teams (IWT) within Procurement and act as the link between the PMO team, the business units and the suppliers
Coordinate and execute Supplier’s strategies related to aircraft change management
Be responsible for all procurement related activities for specific commodities related to change management
Act as a project manager to ensure all procurement related activities are executed as per plan
Actively participate and represent Procurement within the various Integrated Work Teams (IWT)
Track supplier changes through the management process up to the point of implementation
Develop negotiation business strategies, lead/support contractual negotiations, resulting from product changes, with external suppliers
Ensure that correct project tracking and visibility are provided by the suppliers for Procurement and other business unit functions
Support, where applicable, the Procurement commodity teams in establishing sourcing strategies and draft commercial agreements with the suppliers

What we offer

Insurance plans (Dental, medical, life insurance, disability, and more)
Competitive base salary
Retirement savings plan
Employee Assistance Program
Tele Health Program

Fulltime

Specialist Manufacturing New Product Introduction

Amgen

Location:
United States , Holly Springs

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 20, 2026

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Supply Chain Specialist - New Product Introduction

Specialist Manufacturing New Product Introduction

Amgen

Location:United States , Holly Springs

Category:Manufacturing

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:February 20, 2026

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United States , Holly Springs

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Job Posted:
February 20, 2026