New Product Introduction Lead Job at Amgen (Thousand Oaks)

Exe New Product Introduction: Project Lead

ASML US brings together the most creative minds in science and technology to dev...

Location

United States , Wilton

Salary:

Not provided

ASML

Expiration Date

Until further notice

Requirements

Bachelors Degree in an engineering field with 6+ years of manufacturing or production experience, with at least 2 years in a leadership experience
Masters Degree in a engineering field with 4+ years of experience in a manufacturing or production environment, with at least 2 years in a leadership experience

Job Responsibility

Development of NPI Product line to volume worthy production
Interface with multi-functional sectors for issue resolution
Key deliverable tracking and reporting to Sr Management
Technical Synchronization of output schedule between departments
Cycle Time analysis
Develop Manufacturing readiness plans to introduce new products into Production across multiple projects
Develop budgetary needs for facilities, capital equipment and headcount
Communicate Manufacturing readiness plans to Business Line and Management
Lead a cross functional team from Production Engineering, Operations and Logistics to implement Manufacturing readiness plans for new product industrialization
Evaluate subassemblies for Make/Buy decision

Fulltime

Project Manager Product Development Heat Exchangers – New Product Introduction Division

The AKG Group has been a specialist in the field of heat transfer since 1919. Wi...

Location

Germany , Hofgeismar

Salary:

Not provided

AKG Termoteknik Sistemler

Expiration Date

Until further notice

Requirements

Degree in mechanical engineering, refrigeration engineering, process engineering, or a similar technical field
Several years of experience in product development of heat exchangers, thermal components, or related technologies in industry
In-depth knowledge of thermodynamics and fluid mechanics
Excellent communication and presentation skills in German and English
Experience in project management of interdisciplinary teams

Job Responsibility

Managing product development projects for heat exchangers and systems from the concept phase to series production
Designing, evaluating, and optimizing heat exchangers and components relevant to AKG in cooling and refrigerant circuits
Acting as a technical interface and working closely with internal teams, suppliers, and external partners to develop innovative solutions
Support in conducting and evaluating tests and simulations to assess product performance, efficiency, and reliability
Support in creating and maintaining technical documentation, specifications, and reports, as well as in training internal teams and customers
Actively contributing new ideas for the further development of the product portfolio—ideally leading to patentable solutions

What we offer

Long-term prospects
Team spirit that connects
Technology that inspires
Career growth on site
Stability with purpose
Local impact, global reach

Fulltime

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

Principal Technical Program Manager - New Product Introduction

The Microsoft Customer Experience & Success (CE&S) organization is responsible f...

Location

United States , Redmond

Salary:

139900.00 - 274800.00 USD / Year

Microsoft Corporation

Expiration Date

Until further notice

Requirements

Bachelor's Degree AND 6+ years’ experience in engineering, product/technical program management, or product development OR equivalent experience
1+ years people management experience
3+ years of experience managing cross-functional and/or cross-team projects
Bachelor's Degree AND 12+ years’ experience engineering, product/technical program management, or product development OR equivalent experience
4+ years people management experience
8+ years of experience managing cross-functional and/or cross-team projects
1+ year(s) of experience reading and/or writing code (e.g., sample documentation, product demos)
3+ years of experience in management consulting
Demonstrated experience driving new product into (NPI), support readiness, launch quality, or operational programs with executive visibility
Technical understanding of Microsoft products and solution areas

Job Responsibility

You will deliver the successful transformation of the NPI process landing changes within the NPI team and with Engineering, Marketing, Customer Success Unit (CSU), Customer Service and Support (CSS), and ISD - consulting
You will manage day-to-day operations that ensure Day Zero readiness across the release of all new products and features across solution areas as well as end of support readiness to drive customer experience and accelerate time to value
You will proactively identify readiness risks and drive corrective actions ahead of launch
You will build trusted relationships with stakeholders across CE&S and in Engineering, Marketing, and elsewhere across Microsoft and communicate readiness status, tradeoffs, and risks with clarity and credibility (including to Vice President (VP) and Corporate Vice President (CVP) level audiences)
You will influence decisions on launch timing, management of End of Support (EOS) and risk mitigation strategies using data driven insights and field signals
You will apply technical judgment across the full spectrum of product releases including Security, Identity, Compliance, Cloud, and AI Platforms
You will lead, coach, and develop team managers and establish a culture within the NPI organization of technical depth, customer orientation, and continuous learning and innovation

Fulltime

Specialist Manufacturing New Product Introduction

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

Job Responsibility

Communicate and interface between the GMP manufacturing teams and Process Development scientific groups
Ensure new products are successfully introduced into the biologics manufacturing facility
Host cross-functional meetings to drive timelines to support the tech transfer of the program into the facility
Propose, participate, and lead team improvement initiatives to drive improved productivity and scheduling accuracy
New Product Introduction 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
Technical expert who leads or participates in projects, ensuring that production documents are accurate and up to date
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

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

New Product Introduction (NPI) Engineer

Syntech Recruitment has partnered with a leading precision machining company tha...

Location

Ireland , Co. Louth

Salary:

40000.00 - 52000.00 EUR / Year

SYNTECH RECRUITMENT LTD

Expiration Date

Until further notice

Requirements

Level 7 Bachelor’s Degree in Engineering or related field, or equivalent
At least 3 years’ experience in a fast-paced manufacturing environment
Strong background in working with CNC machines and robotics

Job Responsibility

Oversee and coordinate the RFQ process, ensuring alignment with project requirements
Lead the entire New Product Introduction process, from initial concept through to full production
Collaborate with engineering teams to support product design and development phases
Identify and implement improvements within the production and NPI processes to enhance efficiency
Utilise Epicor ERP software to track project progress and maintain accurate documentation

What we offer

Life Insurance
Pension Scheme
Health Insurance Discounts

Fulltime

Manager Manufacturing, New Product Introduction

In this vital role you will act as the Manager for the New Product Introduction ...

Location

United States , Holly Springs

Salary:

126376.00 - 159170.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of Manufacturing or Operations experience
Associate’s degree and 10 years of Manufacturing or Operations experience
Bachelor’s degree and 5 years of Manufacturing or Operations experience
Master’s degree and 3 years of Manufacturing or Operations experience
Doctorate degree

Job Responsibility

Directly manage a team of NPI leads responsible for introduction of new products and/or advanced technologies into the plant
Proactively assess the NPI team capabilities to meet the evolving drug substance supply needs
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
Interacts with management in planning, developing, and maintaining budget
Assist in developing and maintaining department goals
Interact with regulatory agencies as needed

What we offer

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

Fulltime

Process Development Product Lead

The Product Lead (Repatha), Process Development is accountable for end-to-end pr...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a technical discipline required
Master’s degree or equivalent experience preferred
5–7 years’ experience in biopharma/pharma (cGMP environment), with demonstrated leadership in manufacturing/technical operations and cross-functional delivery
Working technical knowledge relevant to Repatha manufacturing and lifecycle execution (e.g., parenteral fill-finish and/or primary packaging/combination product interfaces, as applicable)
Track record identifying risks/gaps and implementing practical mitigation/remediation plans through cross-functional teams
Demonstrated technical and/or program leadership experience, including translating objectives into integrated, measurable execution plans
Strong process and manufacturing execution background
Strong matrix leadership capability
Solid understanding of development, manufacturing, validation, quality, regulatory, and product lifecycle management processes in a cGMP environment
Demonstrated programme/project leadership skills (planning, risk management, governance, stakeholder alignment, and delivery tracking)

Job Responsibility

Act as the Product Health Steward for Repatha at ADL, owning product health through effective product governance and disciplined cross-functional leadership
Lead and facilitate key Repatha project governance forums (e.g., team meetings, weekly/monthly product reviews) to ensure clear decisions, follow-up, and execution
Ensure relevant site goals, network Governance Approved Baselines (GABs) and key governance decisions are translated into site action plans and prioritized appropriately
Develop and maintain the site lifecycle management (LCM) program for Repatha, including scope definition, prioritization, and execution oversight across the product team
Contribute to the long-term site product vision and strategy for Repatha, ensuring alignment with ADL strategy and network expectations
Support new product/market introductions and Repatha SKU changes, coordinating readiness and execution across site functions
Serve as ADL’s primary point of contact for Repatha Global Operations Leads (GOLs) and Product Delivery Teams (PDTs)
Ensure ADL needs, constraints, and priorities are clearly articulated and appropriately represented in site and global governance
Build and maintain strong working relationships with product/process knowledge SMEs at both site and network level
Own the site product risk register for Repatha

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New Product Introduction Lead

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