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 Manufacturing New Product Introduction (NPI) - Upstream

Specialist Manufacturing New Product Introduction (NPI) - Upstream at Amgen in H...

Location

United States , Holly Springs

Salary:

107545.40 - 145502.60 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of biotechnology operations experience OR Associate’s degree & 8 years of biotechnology operations experience OR Bachelor’s degree and 4 years of biotechnology operations experience OR Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR Doctorate degree

Job Responsibility

Communicate and interface between GMP manufacturing teams and Process Development scientific groups
Ensure new products are successfully introduced into ANC’s biologics manufacturing facility
Host cross-functional meetings to drive timelines to support tech transfer
Propose, participate, and lead team improvement initiatives to drive improved productivity and scheduling accuracy
Coordinate with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, and Quality to introduce new Drug Substance products and/or advanced technologies
Lead or participate in projects ensuring production documents are accurate and up to date
Support Manufacturing in troubleshooting, problem solving and RCAs
Own New Product Introduction Change Controls and collaborate with stakeholders to drive on-time completion
Respond to regulatory questions and/or audit findings
Champion Lean Transformation and OE initiatives.

What we offer

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
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.

Fulltime

Specialist Manufacturing: Process Owner, Manufacturing Services

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

Location

United States , Holly Springs

Salary:

107545.40 - 145502.60 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience or Bachelor's degree and 5 years of biotechnology operations experience or Associate's degree & 10 years of biotechnology operations experience or High school diploma / GED & 12 years of biotechnology operations experience

Job Responsibility

Manufacturing services technical expert who leads weigh and dispensing operations, media and buffer solution preps and participates in projects, including aiding in commissioning and qualification and training staff on single-use technology, analytical equipment and processes
Coordinating with New Product Introduction (NPI) team, Manufacturing, Process Development, Supply Chain, 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)
Support Manufacturing in troubleshooting, problem solving and participating in deviation RCAs
Own and CAPA and Change Controls to prevent error recurrence and continuous improvement
Ensure that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and align with electronic batch records
Lead tabletop and water runs to test records and SOP updates prior to use before major changes
Provide hypercare support during first batch runs, PPQs, and/or during implementation of new technologies

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives

Fulltime

Product Manager

A global advanced manufacturing business is looking to appoint a commercially fo...

Location

United Kingdom , Cambridgeshire

Salary:

Not provided

Cranleigh STEM

Expiration Date

Until further notice

Requirements

Experience in product management within a manufacturing or engineered products environment
Strong commercial awareness – pricing, margin, portfolio performance
Comfortable working cross-functionally across sales, operations and technical teams
Experience supporting customer-facing activity, RFQs and product launches
Degree or equivalent experience in engineering, technical or commercial discipline

Job Responsibility

Own and develop a specialist product portfolio aligned to short- and long-term business objectives
Drive pricing strategy, margin performance and competitive positioning
Lead and prioritise new product introductions, including trials and qualification activity
Support RFQs, long-term agreements and customer growth strategies
Act as the link between Sales and Operations, contributing to SIOP, demand validation and capacity alignment
Monitor market trends and competitor activity to inform roadmap decisions
Represent the product range in customer meetings, internally and externally

What we offer

Bonus

Fulltime

Manufacturing Execution Systems Specialist

This role is focused on design, development, validation, and continuous improvem...

Location

United States , Thousand Oaks

Salary:

107545.40 - 145502.60 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of Manufacturing Execution Systems experience OR Bachelor's degree and 4 years of Manufacturing Execution Systems experience OR Associate's degree and 8 years of Manufacturing Execution Systems experience OR High school diploma / GED and 10 years of Manufacturing Execution Systems experience

Job Responsibility

Design, develop, and maintain DP Manufacturing Electronic Batch Records (EBRs) using Körber PAS-X
Translate DP manufacturing processes / user requirement specifications into compliant MES templates, recipes, and workflows
Ensure EBRs and data reporting out of MES are robust, efficient, and aligned with GMP requirements
Support validation activities for MES / EBRs including testing and defect resolution
Provide day-to-day MES support to manufacturing operations, including troubleshooting and on-call support
Partner with NPI leads to enable MES readiness for New Product Introductions
Support deployment of new MES capabilities and system integrations (SAP, PI, DeltaV, Rockwell, Kepware)
Identify and implement improvements to MES design, usability, and performance
Contribute to MES standardization and best practices across the site and network
Support change control activities ensuring compliance with GMP procedures

What we offer

A 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
Flexible work models where possible

Fulltime

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Specialist Manufacturing New Product Introduction

Job Description

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