CrawlJobs Logo

Contract Development and Manufacturing Senior Manager

amgen.com Logo

Amgen

Location Icon

Location:
Japan , Tokyo

Category Icon
Category:
-

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

Oversee Amgen Contract Development and Manufacturing (ACDM) sites through executing activities according to Good Manufacturing Practices (cGMP) principles and the ACDM business practices. This role will require the candidate to be regionally based in Japan, with strong technical communication skills required in both Japanese and English.

Job Responsibility:

  • Project leadership for Amgen modalities (Synthetic DP/FDP, Biologics DP/FDP) external projects spanning development, clinical and commercial manufacture
  • Develop scopes of work in close partnership with functional leads
  • Build and maintain positive relationships with Process Development and other functions
  • Manage of multiple assignments and/or business processes
  • Establish and maintain external collaborations and monitor supplier performance
  • Manage purchase orders, financial forecasting, and associated budget for externalization
  • Ensure projects and/or programs meet results, compliance, speed, quality, and cost
  • Identifying project optimization opportunities
  • Contribute to ACDM knowledge development including assessment of industry trends, technology advancement, and contract manufacturing landscape
  • Ability to understand legal contracts to support negotiation process with suppliers
  • Drive risk management, operations excellence, and other Operations initiatives
  • Travel 20%: Domestic and International

Requirements:

  • Doctorate degree and 2 years of Manufacturing or Operations experience
  • Master’s degree and 6 years of Manufacturing or Operations experience
  • Bachelor’s degree and 8 years of Manufacturing or Operations experience
  • Associate’s degree and 10 years of Manufacturing or Operations experience
  • High school diploma / GED and 12 years of Manufacturing or Operations experience
  • Candidates must demonstrate professional fluency in English, including strong written and verbal communication skills
  • 8+ years proven experience in Pharmaceutical Manufacturing
  • 8+ years working knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
  • 5+ years demonstrated ability working with external parties and/or leading cross-functional teams for clinical and/or commercial products
  • 3+ years of project management experience leading multi-functional and multi-location team
  • Experience interacting with domestic and international suppliers, including import and export policies
  • Self-starter, comfortable with ambiguity and complexity and the ability to successfully multi-task while consistently delivering quality results
  • Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management
  • Business acumen, high level strategic thinking, and strong analytical skills with the ability to structure, pragmatically scope, and solve complex problems

Nice to have:

  • Preferred experience with CDMOs/CROs
  • Understanding of drug development, manufacturing and commercialization for Amgen modalities (Synthetic DP/FDP, Biologics DP/FDP)
  • Demonstrated ability to pivot between modalities or phase of drug lifecycle ie. early vs. late stage, clinical versus commercial
What we offer:
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Additional Information:

Job Posted:
January 03, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Icon
Amgen - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Contract Development and Manufacturing Senior Manager

Senior Director, Drug Substance Development and Manufacturing

Lead and oversee all outsourced drug substance manufacturing operations. Reporti...
Location
Location
United States , Waltham; San Diego
Salary
Salary:
210000.00 - 270000.00 USD / Year
kailera.com Logo
Kailera Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of 10+ years of progressive, relevant experience in drug substance development and manufacturing
  • Deep expertise in both synthetic and recombinant manufacturing approaches
  • Hands-on experience with the synthesis and manufacturing of peptides is mandatory
  • Demonstrated track record in managing clinical-scale supply, process characterization and optimization, technical transfers, and process validation activities
  • Sound technical skills in applying scientific principles to complex process design, implementation, and successful technology transfer
  • Solid knowledge of current Good Manufacturing Practices (cGMPs), Quality systems, and global regulatory requirements (e.g., FDA, EMA)
  • Proven experience with the drafting, review, and authoring of CMC sections for major global regulatory submissions (e.g., IND, NDA, MAA)
  • Exceptional solution-based critical thinking skills and the ability to operate with a keen sense of urgency and an entrepreneurial spirit
  • Demonstrated ability to ensure accountability of self and others, coupled with strong detail-orientation to proactively identify and mitigate risks and issues
  • Ability to strategically contribute to and manage multiple concurrent projects
Job Responsibility
Job Responsibility
  • Direct and lead all process development, scale-up, technology transfer, and validation activities for peptide drug substance manufacturing across all Contract Development and Manufacturing Organizations (CDMOs)
  • Establish and drive continuous improvement initiatives focused on enhancing manufacturing efficiency, enabling cost reduction, and establishing strategic redundancies across the CDMO network
  • Define the long-term vision for manufacturing by maintaining a deep knowledge of industry trends, technological advancements, green manufacturing processes, and emerging regulatory changes
  • Manage and enforce CDMO performance against key project timelines, deliverables, and costs
  • Lead the negotiation and execution of complex technical agreements and work orders with CDMO partners
  • Oversee budget planning and forecasting for all outsourced drug substance manufacturing activities
  • Serve as the strategic lead for drug substance activities, driving seamless collaboration across Analytical Development, Formulation, Quality Assurance, and Regulatory Affairs
  • Oversee the preparation and completion of drug substance modules (e.g., Module 3) for all regulatory dossiers (e.g., IND, NDA)
  • Direct the preparation and final authorship of high-quality technical reports, executive summaries, and presentations to effectively communicate results and progress to internal leadership and external stakeholders
What we offer
What we offer
  • Comprehensive health benefits and tax-advantaged savings accounts
  • Flexible time off, 13 paid holidays, and a companywide year-end shutdown
  • Monthly wellness stipend
  • Generous 401(k) match
  • Disability and life insurance
  • Fulltime
Read More
Arrow Right

Senior Project Manager

Senior Project Managers have a high level of expertise in both product manufactu...
Location
Location
United States , Akron
Salary
Salary:
90000.00 - 100000.00 USD / Year
onqsolutions.com Logo
OnQ
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • OnQ requires full COVID vaccination as a condition of employment
  • 5+ years of proven experience with project management, specifically with Point of Purchase or other retail displays
  • Mastery managing the life cycle of Point of Purchase display projects for retail
  • Relevant educational background, preferably in the fields of design, supply chain, manufacturing, or engineering
  • Experience managing the design and manufacturing of products
  • Solid understanding of common product warehousing, inventory, and shipping practices
  • Experience managing onshore and offshore contract manufacturers including purchasing and cost negotiation
  • Working knowledge of QA and QC practices common to product manufacturing
  • Strong knowledge of manufacturing methods particular to plastics, woodworking, and machined and fabricated metal processes
  • Excellent client-facing and internal communication skills
Job Responsibility
Job Responsibility
  • Manage individual projects from the early planning stage through design, prototyping, purchasing, production, shipping and billing of the final product
  • Coordinate internal resources and third parties towards the flawless execution of projects
  • Ensure that all projects assigned are delivered on-time, within scope, and on budget
  • Assist in the definition of project scope, involving all relevant stakeholders and ensuring technical feasibility
  • Manage project costs, set budgets, and handle project billings
  • Attend stakeholder meetings to confirm project objectives, execution obstacles, in-store variables, and other factors that will impact program success
  • Ability to act as the primary POC between OnQ and various stakeholders to drive necessary research and data collection, manage client expectations and ensure key timelines are met
  • Analyze retailer data and category/fixture layout to translate into internal production and materials orders
  • Ensure resource availability and allocation to meet project requirements (both internal and external)
  • Develop detailed project plans to monitor and track progress
  • Fulltime
Read More
Arrow Right

Senior Manager, Hardware Engineering

We are looking for a highly skilled and dynamic Senior Hardware Manager to join ...
Location
Location
United States , San Jose
Salary
Salary:
148000.00 - 340500.00 USD / Year
https://www.hpe.com/ Logo
Hewlett Packard Enterprise
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s or master’s degree in electrical engineering, Computer Engineering, or a related field
  • Minimum 8 years of management experience in hardware development, with hands-on experience in Contract Manufacturing (CM) and Original Design Manufacturer (ODM) development methodologies
  • Strong background in hardware design, prototyping, and manufacturing processes, including board design, FPGA design, high-power SoC based systems, and CPU subsystem design
  • Proven track record of managing product development for Networking (switching/routing/security) Systems
  • Excellent understanding of supply chain management, production schedules, and cost optimization
  • Strong leadership and team management skills, with experience leading cross-functional teams
  • Demonstrated ability to manage multiple projects simultaneously and lead teams to meet deadlines and business objectives
  • Excellent communication and interpersonal skills, with the ability to negotiate and manage vendor, partner, and customer relationships
  • Strong problem-solving skills, ability to troubleshoot complex hardware development challenges, and attention to detail.
Job Responsibility
Job Responsibility
  • Lead, manage, and mentor a hardware development team, ensuring high performance, innovation, and effective collaboration across design, engineering, and manufacturing teams
  • Oversee the entire hardware lifecycle from concept through production, ensuring projects are delivered on time, within budget, and to the highest quality standards
  • Work closely with ODM partners to drive hardware design, manufacturing and assembly processes, ensuring quality, cost-effectiveness, and timely production
  • Collaborate with hardware and software architects, software development and test teams, and product management teams to define hardware requirements, specifications, and timelines
  • Ensure hardware meets product requirements by managing bring-up and lab testing activities
  • Drive DVT testing, validation, and certification processes
  • Identify and mitigate risks associated with hardware design, production, and supply chain issues
  • Oversee the development of hardware prototypes with focus on continuous improvement and eventual release to production
  • Drive and participate in reviews of design documentation, schematics and PCB designs, and hardware test plans
  • Develop and implement processes to improve hardware performance, reliability, and manufacturability
What we offer
What we offer
  • Health & Wellbeing
  • Personal & Professional Development
  • Unconditional Inclusion
  • Fulltime
Read More
Arrow Right

Senior Technical Project Manager

We are seeking an experienced and highly motivated Project Manager to join our S...
Location
Location
United States , South Jordan
Salary
Salary:
Not provided
cricut.com Logo
Cricut
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Engineering (Mechanical Engineering, Manufacturing Engineering or Process Engineering strongly preferred)
  • Working knowledge of software/firmware and some programming background
  • Familiar with electronics, with the ability to read and understand electrical schematics and wiring diagrams
  • 2+ years in Project Management related to product development
  • 5+ years working on products and assembly lines in a Mechanical Engineering, Process or Manufacturing Engineering capacity
  • Ability to utilize various technologies and tools to effectively manage projects and provide clear and concise communications to teams and stakeholders
  • Adept in Microsoft Project, MS Excel, Jira. Proficiency in Minitab desirable
  • The ability to understand and apply statistical process control methods is highly desirable including Cpk’s, T-Tests, X-Bar/R charts, DOE’s, etc.
  • Must be willing to work in our Salt Lake City (South Jordan) office Monday through Friday each week
  • Ability to regularly travel to Asia as needed (likely 4x/yr, can include travel to Malaysia and other areas of Asia)
Job Responsibility
Job Responsibility
  • Work as the technical and programmatic focal point and facilitator for Sustaining Engineering activities in our Utah office
  • Prioritize highest value projects with US SE team and organize resources against them
  • backlog other ideas to keep SE to-do lists lean
  • Identify part, product and assembly issues quickly and work through root cause to resolution
  • Prepare budgets, purchase orders and schedules as needed for SE projects
  • Identify cost-reduction opportunities at a part, product, assembly and calibration level
  • Coordinate testing activities with engineers and the quality department to ensure product meets engineering and product specifications
  • Manage, document and confirm product changes at multiple contract manufacturers
  • check and maintain consistency of solutions/updates across multiple contract manufacturers
  • Ensure that management and stakeholders are notified of any potential schedule impacts
  • Fulltime
Read More
Arrow Right

Senior Director, Analytical Development and Quality Control

The Altos Institute of Medicine will capture knowledge generated about cell heal...
Location
Location
United States , Redwood City
Salary
Salary:
283900.00 - 384100.00 USD / Year
altoslabs.com Logo
Altos Labs
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Ph.D. in analytical sciences or biological sciences
  • Minimum 15+ years of analytical development and QC experience in biotech/pharmaceutical industry
  • 10+ years of Management experience
  • Highly experienced in developing and implementing assays for Quality Control testing and characterization of drug substance, drug product and manufacturing in-process samples
  • Experienced in multiple modalities including biologics, oligonucleotides, small molecules, mRNA/LNP and AAV gene therapy
  • Experienced in leading CMC team and analytical subteam
  • Proficient in cGMP’s and pharmaceutical industry procedures and regulations
  • Highly experienced in achieving CMC deliverables through outsourcing to Contract Manufacturing Organizations
  • Leadership experience in managing diverse project activities with contract CDMO facilities at global locations
  • A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs
Job Responsibility
Job Responsibility
  • Lead analytical development and quality control across multiple modalities
  • Build a high performing team and establish internal and external analytical and QC capabilities
  • Serve as CMC lead and analytical lead for Altos therapeutic programs
  • Manage contract manufacturing organizations and CROs to develop and qualify analytical testing methods, perform product characterization, release and stability testing, and in-process testing
  • Establish product specifications to ensure product quality
  • Support technical assessment of Out of Specification and Non-Conforming investigations
  • Author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents
  • As a member of the Tech Ops leadership team, build the Tech Ops organization, processes, systems and infrastructure
  • Create and foster strong partnerships with Institutes of Science, Institutes of Technology, Institute of Computation, drug discovery and development sciences, clinical, regulatory, program management, business development, legal and finance
  • Actively contribute to a team culture that promotes continuous improvement, accountability, professional growth, and inclusion
  • Fulltime
Read More
Arrow Right

Senior Director of Product Management

The goTenna Product team is seeking a highly professional and experienced Produc...
Location
Location
Salary
Salary:
175000.00 - 220000.00 USD / Year
gotenna.com Logo
goTenna
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 6+ years of experience working as Director of Product Management, Product Lifecycle Manager or Product Portfolio Manager in a technical product field - preferably in the telecoms, LMR radio or satellite systems segments
  • 4+ years of experience with Agile methodologies for Software Development (including use of Jira & Confluence)
  • 3+ years of experience with Waterfall/Stage-Gate methodologies for Hardware Development processes
  • Demonstrated experience managing business initiatives involving a portfolio of products in various lifecycle stages
  • Experience conducting market research, technical research and competitive analysis
  • Professional Communication skills: project specifications, documentation and presentations
  • Experience directly managing Product Managers and/or Product Owners
  • ITAR: U.S. Citizen or Green Card Required
Job Responsibility
Job Responsibility
  • Strategic Product Leadership: The Senior Director of Product Management is the key owner of an assigned product or product portfolio
  • Portfolio Strategy: Working in conjunction with the VP of Product and key internal and external stakeholders, the Product Manager shall define and communicate a compelling, long-term product strategy that aligns with market opportunities, customer needs and overall business objectives
  • Market & Competitive Analysis: Conduct deep market research, including regular interaction with current lighthouse customers, target market customers, industry experts, and sales channels
  • Business Case Development: Develop and maintain robust business cases for new product investments, justifying resource allocation, forecasting financial returns (ROI), and defining success metrics
  • Go-to-Market Strategy: Partner with Marketing, Sales, and Business Development to define and execute effective go-to-market plans for product launches
  • Customer & Stakeholder Empathy: Serve as the primary voice of the customer, translating complex operational requirements from critical communications end-users into actionable product requirements
  • Roadmap Management: Own, prioritize, and maintain the product roadmap for the product or product portfolio
  • Requirements Definition: Create clear, concise, and prioritized Product Requirements Documents (PRDs), translating those requirements into initiatives and feature epics
  • Feature Prioritization: Use data-driven decisions, product strategic goals, and market feedback to make tough, objective decisions on feature trade-offs and backlog prioritization
  • Lifecycle Management: Manage products across their entire lifecycle, including defining end-of-life strategies and transition plans for legacy systems
What we offer
What we offer
  • Equity
  • 401(k) plan
  • Unlimited PTO
  • Parental Leave with Pay
  • Holiday pay (including December recess)
  • Medical, Dental, Vision and life insurance
  • Pre-tax benefits
  • Short- and Long-term disability plans
  • Professional Development Stipend
  • Fulltime
Read More
Arrow Right

Contract Senior Mechanical Engineer

We are seeking a Contract Senior Mechanical Engineer to lead the development of ...
Location
Location
United States
Salary
Salary:
Not provided
speckdesign.com Logo
Speck Design
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s or Master’s degree in Mechanical Engineering or a related field
  • At least 7 years of mechanical engineering experience with a proven ability to lead projects from conception to production
  • Expertise in Creo ProE CAD software, with extensive experience in mechanical design, particularly using sheet metal
  • Strong project management skills with the ability to oversee multiple projects simultaneously
  • Excellent communication skills with experience working in a team environment, capable of leading and mentoring junior engineers
  • In-depth knowledge of mechanical design processes and familiarity with industry standard CAD tools
  • 7+ years in mechanical engineering with substantial experience in design and production
  • Exceptional problem-solving skills and the ability to adapt to new challenges and technologies
Job Responsibility
Job Responsibility
  • Utilize Creo ProE CAD software to develop complex mechanical designs and models
  • Design and prototype mechanical components with a particular focus on sheet metal projects
  • Collaborate across multidisciplinary teams to ensure designs meet all specifications and are optimized for manufacturing
  • Oversee the mechanical aspect of projects from conceptualization through to production, handling material selection and the manufacturing processes
  • Engage in the continuous improvement of design practices and methodologies
Read More
Arrow Right

Senior Global Supply Manager

We’re hiring a Senior Global Supply Manager (Electronics) to lead strategic sour...
Location
Location
United States , Boston
Salary
Salary:
130000.00 - 185000.00 USD / Year
whoop.com Logo
Whoop
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in supply chain, business, logistics, or a related field
  • technical education in electrical engineering strongly preferred
  • 8+ years in strategic sourcing and commodity management of electronic components within CM/JDM/ODM environments
  • Deep knowledge of electronic components relevant to fitness wearables, such as semiconductors, power management, wireless modules, and sensors
  • Strong experience working with Tier 1 electronic distributors and component manufacturers in North America and Asia
  • Proficient in supplier contract negotiation, cost modeling, and understanding of component liability balancing
  • Strong commitment to embracing and leveraging AI tools in day-to-day tasks, ensuring AI-assisted work aligns with the same high-quality standards as personal contributions
Job Responsibility
Job Responsibility
  • Own commercial relationships with suppliers from quotation through execution, including negotiation of all cost elements and analysis of variances
  • Lead weekly and quarterly supplier reviews, including clear-to-build readiness, capacity planning, and KPI performance
  • Develop and manage silicon and semiconductor sourcing strategies with a focus on risk mitigation and supply flexibility
  • Stay ahead of market trends and proactively resolve component supply issues through collaboration with internal teams and external partners
  • Evaluate sourcing opportunities across quality, cost, inventory, and delivery metrics
  • support product lifecycle decisions with cost and supply insights
  • Partner with hardware engineering to align component selection with product performance and innovation goals
  • Contribute to WHOOP’s broader supply chain initiatives by ensuring commodity alignment and continuity across sourcing programs
  • Travel up to 25% to strengthen supplier partnerships and maintain global oversight
What we offer
What we offer
  • equity
  • benefits
  • Fulltime
Read More
Arrow Right
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Germany Jobs Poland Jobs Ireland Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
CrawlJobs Group
ITFlashcards AllDevBlogs
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy