CrawlJobs Logo
Amgen Logo Amgen · Manufacturing

Senior Manufacturing Associate

Singapore, Singapore Employment contract · Job Posted June 28, 2026
Apply Position
Job Link Share

Job Description

This position supports contamination control, inspection readiness and process support deliverables for ASM Manufacturing. Under general direction, the role partners with Manufacturing, Quality, Compliance, Facility & Engineering, EHSS and other stakeholders to maintain GMP readiness, identify potential contamination risks, support investigations and drive assigned improvement actions.

Job Responsibility

  • Support execution of the ASM1 Manufacturing contamination control program under direction of the Contamination Control Lead
  • Own deviations (minor/major), perform data gathering/investigation, impact assessment and documentation support for contamination-related events, deviations and CAPA
  • Lead low-to-moderate complexity investigation workstreams and support complex investigations led by the Contamination Control Lead
  • Prepare and maintain assigned dashboards, metrics and follow-up trackers for site and network discussions
  • Support maintenance of cleanroom procedures, gowning practices, contamination response procedures and environmental monitoring program deliverables
  • Coordinate with the EM Sampling team, area owners and cross-functional stakeholders to ensure sampling readiness, timely follow-up and closure of observations
  • Drive assigned actions and small-to-moderate improvement initiatives to improve contamination control effectiveness
  • Support CAPA applicability assessment and implementation of identified CAPA (if required)
  • Prepare, verify and organize inspection support materials, storyboards, pressure test packages and evidence binders as assigned
  • Support triage room activities during regulatory inspections, including request coordination, document retrieval and response preparation under lead direction
  • Partner with Compliance and cross-functional teams to ensure prompt follow-up on inspection requests, observations, near misses and lessons learnt
  • Serve as SME to present deviations, CAPA, change control records when required during inspections
  • Lead/Support manufacturing deviation investigations, impact assessments, batch record/documentation reviews and manufacturing technical assessments
  • Initiate, assess and implement low-to-moderate complexity change controls with guidance
  • support complex change controls
  • Identify digitalization/improvement opportunities to drive improvement in deviation, CAPA and change control work processes

Requirements

  • Masters Degree OR Bachelor's Degree and 2 years of directly related experience OR Associate's Degree and 6 years of directly related experience OR High School Diploma / GED and 8 years of directly related experience
  • Technical knowledge of biopharmaceutical upstream, downstream processing, cleanroom operations and single use systems
  • Experience in writing and owning major/minor deviations, CAPA and change controls related to contamination control and/or manufacturing
  • Experience leading/supporting investigations, CAPA, audit readiness activities and risk assessments
  • Basic understanding of GMP and regulatory expectations related to manufacturing documentation, change control, deviations/investigations and CAPA
  • Working knowledge of contamination control expectations for biologics manufacturing, including cleanroom behaviour, gowning, EM and contamination response
  • Ability to analyse routine EM/process data, identify trends, communicate risks and escalate appropriately
  • Strong technical writing, communication skills and ability to work effectively with cross-functional stakeholders and network partners
  • Ability to work with limited supervision, prioritize assigned deliverables and follow through on commitments
  • Practical experience and interest in exploring the use of digital technologies (Power BI, Customized ChatGPT etc) to improve workflows and drive continuous improvement

What we offer

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Amgen - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Senior Manufacturing Associate

8 matching positions

New

Senior Manufacturing Associate

This position supports contamination control, inspection readiness and process s...
Location
Location
Singapore , Singapore
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Masters Degree OR Bachelor's Degree and 2 years of directly related experience OR Associate's Degree and 6 years of directly related experience OR High School Diploma / GED and 8 years of directly related experience
  • Technical knowledge of biopharmaceutical upstream, downstream processing, cleanroom operations and single use systems
  • Experience in writing and owning major/minor deviations, CAPA and change controls related to contamination control and/or manufacturing
  • Experience leading/supporting investigations, CAPA, audit readiness activities and risk assessments
  • Basic understanding of GMP and regulatory expectations related to manufacturing documentation, change control, deviations/investigations and CAPA
  • Working knowledge of contamination control expectations for biologics manufacturing, including cleanroom behaviour, gowning, EM and contamination response
  • Ability to analyse routine EM/process data, identify trends, communicate risks and escalate appropriately
  • Strong technical writing, communication skills and ability to work effectively with cross-functional stakeholders and network partners
  • Ability to work with limited supervision, prioritize assigned deliverables and follow through on commitments
  • Practical experience and interest in exploring the use of digital technologies (Power BI, Customized ChatGPT etc) to improve workflows and drive continuous improvement
Job Responsibility
Job Responsibility
  • Support execution of the ASM1 Manufacturing contamination control program under direction of the Contamination Control Lead
  • Own deviations (minor/major), perform data gathering/investigation, impact assessment and documentation support for contamination-related events, deviations and CAPA
  • Lead low-to-moderate complexity investigation workstreams and support complex investigations led by the Contamination Control Lead
  • Prepare and maintain assigned dashboards, metrics and follow-up trackers for site and network discussions
  • Support maintenance of cleanroom procedures, gowning practices, contamination response procedures and environmental monitoring program deliverables
  • Coordinate with the EM Sampling team, area owners and cross-functional stakeholders to ensure sampling readiness, timely follow-up and closure of observations
  • Drive assigned actions and small-to-moderate improvement initiatives to improve contamination control effectiveness
  • Support CAPA applicability assessment and implementation of identified CAPA (if required)
  • Prepare, verify and organize inspection support materials, storyboards, pressure test packages and evidence binders as assigned
  • Support triage room activities during regulatory inspections, including request coordination, document retrieval and response preparation under lead direction
What we offer
What we offer
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Fulltime
Read More
Arrow Right

Senior Associate Manufacturing, Drug Product

At Amgen, our mission—to serve patients—drives everything we do. As a Sr Associa...
Location
Location
United States , Thousand Oaks
Salary
Salary:
86048.05 - 116417.95 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master's degree OR Bachelor's degree and 6 months of Manufacturing support experience OR Associate's degree and 2 years of Manufacturing support experience OR High school diploma / GED and 4 years of Manufacturing support experience
Job Responsibility
Job Responsibility
  • Initiate, revise, and approve controlled manufacturing documents within Amgen's electronic document management system (CDOCs)
  • Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards
  • Maintain documentation to accurately reflect operational practices and regulatory requirements
  • Support implementation of new processes, equipment, and major initiatives within Drug Product operations
  • Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
  • Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
  • Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
  • Develop and implement data-driven solutions to improve yield, reliability, and compliance
  • Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements
  • Support timely investigation and resolution of manufacturing deviations
What we offer
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
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Fulltime
Read More
Arrow Right

Senior Associate Manufacturing

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...
Location
Location
United States , Thousand Oaks
Salary
Salary:
86048.05 - 116417.95 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school/GED + 4 years manufacturing and operations experience OR Associate's + 2 years manufacturing and operations experience OR Bachelor's + 6 months manufacturing and operations experience Master's
  • Degree in Engineering or Life Sciences
  • 3 years or more experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent
  • Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
  • Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
  • Ability to coach, mentor and/or cross train colleagues within core technical area
  • Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities
  • Ability to drive results through leadership of cross-functional teams
  • Experience leading and managing projects
  • Understanding of single-use technologies
Job Responsibility
Job Responsibility
  • Support manufacturing by providing subject-matter expertise for drug substance downstream processes as Single-use SME
  • Resolve quick issues and implement function tests to troubleshoot and optimize process
  • Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management
  • Own Quality Records, such as CCMS, CAPA, and CAPA-EV
  • Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations
  • Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance
  • Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant
  • Demonstrate strategic problem-solving skills and champion continual improvement
  • Ability to be on-site (flexible worker)
  • Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
What we offer
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
Read More
Arrow Right

Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights

Location
Location
United States , Holly Springs
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
  • Associate's Degree + 2 years manufacturing and/or other regulated environment experience
  • Bachelor's Degree + 6 months manufacturing and/or other regulated environment experience
  • Master's Degree
Job Responsibility
Job Responsibility
  • Completes work in accordance with established cGMP procedures and policies
  • Initiate quality non-conformance (NC) reports
  • Interact with regulatory agencies as needed and guided
  • Assure proper gowning and aseptic techniques are always followed
  • Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
  • Perform hands-on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others) including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area
  • Run and monitor critical process tasks per assigned procedures
  • Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR])
  • Complete washroom activities: cleaning equipment, small to large scale, used in production activities
  • Initiate and own manufacturing related process deviations
What we offer
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, or for field sales representatives, a sales-based incentive plan
  • 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
Read More
Arrow Right

Senior Associate, Manufacturing

The Senior Associate reports to the Manager Manufacturing. The ideal candidate w...
Location
Location
Ireland , Dun Laoghaire
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Educated to pass Leaving Certificate standard or equivalent
  • Applicants should have relevant experience of operations of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment
  • Significant experience in a GMP/other regulated environment
  • Demonstrated knowledge of GMP principles
  • Demonstrated aseptic knowledge in GMP areas
  • Drug product manufacturing experience
  • Experience working with equipment utilized in the manufacture of parenteral products such as autoclaves, filling lines and formulation vessels
  • Demonstrated ability to deliver to team, site and personal objectives
  • Demonstrated understanding and use of right first-time techniques and lean manufacturing concepts
  • Results-oriented
Job Responsibility
Job Responsibility
  • Responsible for leading the shift in conjunction with FLM
  • Responsible for outlining roles for the day, ensuring schedule is on track, triaging events, writing deviations, Batch Record Review, Running MDI’s
  • Oversees opportunities from project from training perspective in project phase
  • Support development of SOPs/job-aids/guidance
  • Support the Manufacturing Manager in leading a shift of Process Technicians to achieve production targets efficiently in line with GMP, safety and regulatory standards
  • Ensure shift Process Technicians are given clear direction and information to perform daily tasks as per the production schedule
  • Lead an assigned process area Work Centre Team (WCT) to ensure cross functional alignment on objectives and action plans
  • Maintain an accurate, up-to-date manufacturing schedule reflecting current status of production and plan critical path activities
  • Foster a good safety culture in our team and act as a safety role model
  • Oversee completion and review of documentation (batch records, EBRs) using relevant software systems and Standard Operating Procedures (SOPs)
What we offer
What we offer
  • Health and welfare plans for staff and eligible dependents
  • 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
Read More
Arrow Right

Senior Manufacturing Associate I

Beam Therapeutics is a biotechnology company committed to establishing the leadi...
Location
Location
United States , Durham
Salary
Salary:
80000.00 - 115000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS/MS in Life Sciences or Engineering a plus with minimum of 4-6 years of relevant experience
  • Experience in SAP, Veeva, and Cell Therapy operations strongly preferred
  • Outstanding written and verbal written communication skills
  • Results oriented with the ability to demonstrate resiliency, ownership, and drive
  • Team oriented with excellent collaboration skills
  • Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed
Job Responsibility
Job Responsibility
  • Support multiple areas of GMP production, and lead most operations as needed
  • Establish and maintain strong relationships at the site and cross-functionally
  • Manages and maintains training qualifications for assigned operations, operates as lead trainer on most operations
  • Identifies and revises manufacturing documents (Equipment SOPs) as required
  • Drafts change controls as required and manages small projects for area
  • Performs limited CQV required tasks when needed for any new plant expansions or upgrades
  • Operate in up to an ISO 5/Grade B environment
  • Fulltime
Read More
Arrow Right

Senior Associate Manufacturing - Bulk Drug Substance Downstream

Let’s do this. Let’s change the world. In this dynamic role, you will be a Senio...
Location
Location
United States , Holly Springs
Salary
Salary:
86048.05 - 116417.95 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR Master's Degree
Job Responsibility
Job Responsibility
  • Execute on-the-floor operations within manufacturing in accordance with cGMP practices
  • Complete work in accordance with established cGMP procedures and policies with strict adherence to safety and compliance
  • Initiate quality non-conformance (NC) reports
  • Assure proper gowning and aseptic techniques are always followed
  • Perform hands-on downstream biotech operations including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area
  • Run and monitor critical process tasks per assigned procedures
  • Perform in-process sampling, operate analytical equipment, and complete process documentation
  • Complete washroom activities
  • Initiate and own manufacturing related process deviations
  • Identify, recommend, and implement innovative process improvements and optimizations
  • Fulltime
Read More
Arrow Right

Senior Associate Manufacturing - Continuous Improvement Lead

Join Amgen’s Mission of Serving Patients. In this vital role you will have the o...
Location
Location
United States , Holly Springs
Salary
Salary:
86048.05 - 116417.95 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma / GED and 4 years of Manufacturing or Operations experience
  • Associate’s degree and 2 years of Manufacturing or Operations experience
  • Bachelor’s degree and 6 months of Manufacturing or Operations experience
  • Masters degree
  • Educational background in Life Sciences, Chemistry, Biochemistry, Industrial Biotechnology, and/or Engineering
  • Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
  • Proficient technical writing and presentation skills
  • Ability to lead small and large cross-functional meetings efficiently
  • Knowledge of process improvement or lean fundamentals
  • Collaborate with staff at all levels in the organization
Job Responsibility
Job Responsibility
  • Support the start-up of the Amgen North Carolina (ANC) manufacturing facility
  • Have ownership and oversight of operational readiness activities in manufacturing areas
  • Support Standard Operating Procedure (SOP) creation, review, and approval
  • Specification and purchasing of required equipment and supplies
  • Design of job aids and work instructions
  • Advancement of digital tools to support manufacturing operations
  • Training of staff
  • Manage and lead the CI program for MFG when plant transitions to operations
  • Provide technical support and subject matter expertise for manufacturing area
  • Oversee support and ongoing development of all the manufacturing systems including SOP, TRNQ, MES, QMS records
What we offer
What we offer
  • Competitive and comprehensive Total Rewards Plans aligned with local industry standards
  • Fulltime
Read More
Arrow Right