CrawlJobs Logo

Manufacturing Manager - Site Lead - ACDM

amgen.com Logo

Amgen

Location Icon

Location:
Ireland , Dun Laoghaire

Category Icon
Category:
Manufacturing

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

Site lead for Contract Manufacturing Organizations (CMOs). Single point of accountability and interface between Amgen and assigned external partners.

Job Responsibility:

  • Manufacturing operations: Develop and lead robust business processes, maintain reliable relationships with contract site management
  • assess industry trends, internal network, and technology advancements as tools to improve contract site performance
  • Manage budget development, monitoring, and reporting
  • create and manage contracts - confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
  • monitor and improve financials with CMO
  • actively manage and communicate forecasts to the sites and manage capacity planning
  • Drive operational excellence and champion change
  • Site performance monitoring: Manage contract site performance using lean tools and PDCA, lead site operating review meetings
  • drive improvements at contract sites
  • sustain and improve the overall health of the business, and lead communication/relationship with the contract site as well as internal management
  • Project Management and Technology transfer: Lead a department-wide project from conception to implementation and close-out
  • Present to and obtain buy-in for value proposition of such projects to senior management
  • Provide oversight of all planning and coordination of product transfer activities to the contract site(s)
  • develop, present, and obtain approval of budget, timeline and ensure execution of transfer team activities to achieve seamless product transfer to the contract site(s)
  • ensure risk management initiatives are taking place as per RM plan
  • lead site issue management and resolution
  • provide issue escalation to executive management

Requirements:

  • Bachelor’s in Business Administration, Engineering, or Science-related field
  • 5+ years of experience in 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 experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
  • 1+ years of project management experience leading multi-functional and multi-location team
  • 1+ years of experience across ACDM
  • Ability to travel +/- 20% of time (domestic and international)
  • Demonstrated competencies of lower GCF levels
  • Demonstrated matrix management and influencing skills
  • Manufacturing and cGMP knowledge / experience
  • Demonstrated negotiation skills
  • Operational Excellence proficiency and ability to drive continuous improvement
  • Financial/budgeting knowledge and business acumen
  • Proficient project management skills
  • Problem-solving and critical thinking
  • Understanding of contractual requirements
  • Technical writing and multi-level communication skills
  • Demonstrated ability to lead effectively in collaborative/team environment
  • Demonstrated ability to take initiative, drive action, and work under minimum supervision

Additional Information:

Job Posted:
January 16, 2026

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 Manufacturing Manager - Site Lead - ACDM

New

Offer engineer

Location
Location
Romania
Salary
Salary:
Not provided
Constructii Erbasu
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Higher education
  • Technical and economic knowledge and skills
  • PC operation: Microsoft Office (it is advantageous to use AutoCAD, foreign exchange program, Microsoft Project)
  • Communication skills
  • Ability to organize
  • Concern for individual professional development
Job Responsibility
Job Responsibility
  • Following the execution of the works
  • Preparation of work situations and economic support documents and quality PV for payment certificates
  • Calculation of quantities according to the execution for settlement
  • Drawing up the execution schedules, drawing up the various price offers, maintaining the correspondence with the beneficiaries and the designers of the investments in order to solve the technical problems
  • Preparation of technical books
Read More
Arrow Right
New

Regulatory Affairs Officer

Our client is a leading organisation in the healthcare and diagnostics sector, c...
Location
Location
United Kingdom , Edinburgh
Salary
Salary:
Not provided
srgtalent.com Logo
SRG
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A relevant degree or equivalent experience in regulatory affairs
  • Previous experience in regulatory submissions and compliance within medical devices or related industries
  • Strong knowledge of CE and FDA regulations, including PMA, BLA, and 510(k) submissions
  • Excellent technical writing skills and proficiency in MS Office
  • Ability to work independently and collaboratively in a fast-paced environment
  • Exceptional attention to detail, time management, and problem-solving skills
Job Responsibility
Job Responsibility
  • Prepare and compile regulatory documentation and coordinate submissions for global markets, including US, EU, Canada, and others
  • Advise internal teams on data requirements for successful license applications
  • Develop and maintain product labelling requirements and liaise with stakeholders
  • Monitor regulatory changes and maintain compliance with ISO13485, IVD Directive 98/79/EC, IVD Regulation 2017/746, FDA CFRs, and other global standards
  • Maintain technical files and regulatory documents for multiple territories
  • Communicate effectively with regulatory authorities and external bodies
  • Support process improvements and provide guidance and training to team members
  • Fulltime
Read More
Arrow Right
New

Sterile Processing Tech II

The Sterile Processing Tech II, in conjunction with the Operating Room Instrumen...
Location
Location
United States , Los Angeles
Salary
Salary:
44117.00 - 72478.00 USD / Year
chla.org Logo
Children's Hospital Los Angeles
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 2 years experience in sterile processing
  • High School diploma or equivalent
  • Current Central Service Technician Certification
  • Certification can be obtained within one year of employment with proof of 6 months working experience and completion of CS program and internship
Job Responsibility
Job Responsibility
  • Inspection, preparation, and sterilization of instruments and instrument sets utilized in the Main Operating Room
  • Loads and unloads sterilizers
  • Fulltime
Read More
Arrow Right
New

Electrician

At Sierra Pacific Industries, we understand our greatest strength is the people ...
Location
Location
United States , Anderson
Salary
Salary:
30.52 - 35.97 USD / Hour
spi-ind.com Logo
Sierra Pacific Industries
Expiration Date
February 09, 2026
Flip Icon
Requirements
Requirements
  • 2-year or higher technical degree in relevant field with field experience, or Journeyman Electrician Certification preferred
  • 4 years of industrial experience with verifiable proficiency in the primary duties listed may also be considered in lieu of degree/certification
  • PLC programming experience preferred
  • Experience using Word, Excel, and AutoCAD preferred
  • Knowledge and practical experience using tools of the trade to accomplish duties
  • Ability to read electrical prints and schematics
  • Ability to manage time and priorities under demanding circumstances
  • Excellent communication, listening, and reasoning skills
Job Responsibility
Job Responsibility
  • Build and troubleshoot 480V, 3-phase motor control equipment, PLC panels, operator consoles, and other control system components
  • Install and wire on machine control devices such as photo eyes, proximity sensors, encoders, linear transducers, and other sensors
  • Install conduit, pull and terminate wires, using appropriate tools and methods
  • Install, disconnect, troubleshoot, and repair electrical motors
  • Troubleshoot and maintain Ethernet and other communication networks
  • Commission, program, and troubleshoot VFDs
  • Perform preventative maintenance and diagnosis on equipment
What we offer
What we offer
  • We train and promote from within
  • Excellent low-cost health benefits
  • Retirement plan with employer-paid contributions
  • Paid vacation and 10 holidays
  • full Health Benefits Plan (including medical, dental, and vision) with low-cost premiums
  • a 401(k) with Company Match
  • additional Retirement Contributions
  • company-paid Life Insurance
  • Fulltime
Read More
Arrow Right
New

Topographic engineer

Location
Location
Salary
Salary:
Not provided
Constructii Erbasu
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Higher education in the field
  • Legislative knowledge
  • Control and supervision skills
  • PC operation: Microsoft Office (advantage of Autocad, TopoLT, e-Terra 3)
  • Communication skills
  • Ability to organize (to work and lead teamwork)
  • Concern for individual professional development
Job Responsibility
Job Responsibility
  • Advanced knowledge in processing topographic measurements and preparation of cadastral files / topographic surveys
  • Performing terrestrial measurements with the help of the equipment, by measuring the detail points necessary for further processing
  • Manages and organizes topographic works on site
  • Relates to all the factors involved for the execution of the works: site managers, beneficiary, control institutions, etc
Read More
Arrow Right
New

Food & Beverage Services Supervisor

Ensure staff is working together as a team to ensure optimum service and that gu...
Location
Location
Malaysia , Kuala Lumpur
Salary
Salary:
Not provided
https://www.marriott.com Logo
Marriott Bonvoy
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or G.E.D. equivalent
  • At least 2 years of related work experience
  • At least 1 year of supervisory experience
Job Responsibility
Job Responsibility
  • Ensure staff is working together as a team to ensure optimum service and that guest needs are met
  • Inspect grooming and attire of staff, and rectify any deficiencies
  • Complete opening and closing duties including setting up necessary supplies and tools, cleaning all equipment and areas, locking doors, etc
  • Inspect storage areas for organization, use of FIFO, and cleanliness
  • Complete scheduled inventories and stock and requisition necessary supplies
  • Monitor dining rooms for seating availability, service, safety, and well being of guests
  • Complete work orders for maintenance repairs
  • Assist management in hiring, training, scheduling, evaluating, counseling, disciplining, and motivating and coaching employees
  • Serve as a role model and first point of contact of the Guarantee of Fair Treatment/Open Door Policy process
  • Follow all company and safety and security policies and procedures
  • Fulltime
Read More
Arrow Right
New

Sterile Processing Tech II

The Sterile Processing Tech II, in conjunction with the Operating Room Instrumen...
Location
Location
United States , Los Angeles
Salary
Salary:
44117.00 - 72478.00 USD / Year
chla.org Logo
Children's Hospital Los Angeles
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 2 years experience in sterile processing
  • High School diploma or equivalent
  • Current Central Service Technician Certification
  • Certification can be obtained within one year of employment with proof of 6 months working experience and completion of CS program and internship
Job Responsibility
Job Responsibility
  • Inspection, preparation, and sterilization of instruments and instrument sets utilized in the Main Operating Room
  • Loads and unloads sterilizers
What we offer
What we offer
  • Competitive compensation package
  • Robust benefits program
  • Fulltime
Read More
Arrow Right
New

Medical Writer

The Medical Writer will join a newly formed in-house Curricula team and will be ...
Location
Location
United Kingdom , London
Salary
Salary:
Not provided
srgtalent.com Logo
SRG
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in science preferred
  • Minimum of 5 years related experience is preferred
  • 1-2 years in a Medical Education role is favourable
  • Medical Aesthetics experience is essential
  • Excellent verbal and written communication skills, with a demonstrated ability to communicate clearly and professionally
  • Comfortable discussing scientific data and clinical techniques with senior clinicians and colleagues
  • Proficient with Microsoft Office, including Outlook, Word, Excel and PowerPoint.
  • High degree of flexibility in adapting to a rapidly changing environment.
  • Occasional flexibility in work hours, including weekends, may be required
  • Willingness to travel on a frequent basis
Job Responsibility
Job Responsibility
  • Technical writing for medical aesthetics training content including presentations, learning module scripts, classroom materials, video content
  • Review relevant medical literature and reference materials to fact check information and stay current on latest trends
  • Synthesize complex topics into digestible educational content, adhering to adult learning principles
  • Ensure content adheres to creative and curricula briefs, brand guidelines, and MLRC review guidelines
  • Support with Medical, Legal, Regulatory, and Compliance review systems and processes, ensuring accuracy of copy
  • Responsible for performing all duties in compliance with international regulatory requirements
  • Develop and execute content for the MD Codes programme
  • Oversee and lead the delivery of all MD Codes content, ensuring that timelines, and objectives are met
  • Ensure successful preparation and delivery of high-quality materials for the MD Codes programme, including tour materials at an IMCO and affiliate level
  • Liase with affiliate markets to learn and implement specific local requirements for the tour content
  • 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 Ireland Jobs Poland 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