Senior Associate Manufacturing

Senior Associate Manufacturing, Drug Product

At Amgen, our mission—to serve patients—drives everything we do. As a Sr Associa...

Location

United States , Thousand Oaks

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

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

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

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

Senior Associate, Manufacturing

The Senior Associate reports to the Manager Manufacturing. The ideal candidate w...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

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

Senior Associate Manufacturing, Upstream - Days

Join Amgen’s Mission of Serving Patients. Be part of Amgen's newest and most adv...

Location

United States , Holly Springs

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

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
Completion of NC BioWork Certificate Program
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Basic understanding of Upstream operation (Vial Thaw, Inoculation/Cell Expansion, Single Use Bioreactor, Production Bioreactor, ATF, Harvest Centrifuge, Depth Filtration)
Excellent verbal and written communication (technical) skills
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

Job Responsibility

Execute on-the-floor operations within manufacturing in accordance with cGMP practices
Work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime
Complete work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
Initiate Quality observations (Discrepancies, Deviations, Testing Results Analysis (TRA), etc.) as well as support or lead evaluations and investigations into quality observations
Interact with regulatory agencies as needed and guided
Assure proper gowning and aseptic techniques are always followed
Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment of 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

What we offer

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

Fulltime

As part of Amgen’s Operations organization, Manufacturing continuously strives t...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Educated to pass Leaving Certificate standard or equivalent
A third level qualification in a relevant subject area would be an advantage
Relevant experience of operations of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment
Aseptic experience preferred
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

Job Responsibility

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)
Proactively identify training needs and facilitate completion of training to meet the area resource and cross training models
Assist, plan and implement continuous improvement initiatives using lean principles
Proactively identify and resolve process issues (including escalation and follow up) to minimize production disruptions
Support and assist with corporate, FDA, HPRA and other regulatory bodies during company audits

What we offer

Comprehensive employee benefits package, including 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

Senior Manager / Associate Director, Manufacturing

Beam is looking for a highly energetic Sr Manager/Associate Director, Manufactur...

Location

United States , Durham, NC

Salary:

155000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree preferably with a science or engineering focus and a minimum of 10 years of Manufacturing and Operations experience
At least 2 years experience leading and developing people in a GMP setting
Experience working cross-functionally building and maintaining strong relationships
Autologous cell therapy experience strongly preferred

Job Responsibility

Cultivate Beam’s culture and our values-driven organization focused on people
Execute against the mission, vision, and strategy for Beam internal cGMP Manufacturing
Ensure safety, compliance, efficiency, and sustainability throughout cGMP operations
Lead and coordinate resources to ensure quality standards are met and products are delivered on time and within budget
Champion development of a learning culture that embraces innovation and continuous improvement
Prepare and maintain departmental budget and workforce model in partnership with the Director of Manufacturing
Support establishment of long range and business continuity plans
Manage and support up to but not limited to multiple areas of GMP production as needed
Develop and implement metrics/KPIs to monitor operational health, inform strategic decisions
Build collaborative and empowered teams that put patients first

Fulltime

New

Senior Associate Quality Assurance

The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance ...

Location

United States , Thousand Oaks

Salary:

82081.95 - 111052.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years of GMP experience OR Associate’s + 2 years of GMP experience OR Bachelor’s + 6 months of GMP experience OR Master's
Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field
Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
Experience managing projects through to completion meeting timelines
Ability to evaluate documentation and operations according to company procedures
Experience working with Quality Systems
Strong organizational skills and ability to manage multiple tasks at one time
Effective communication skills (both written and verbal)
Demonstrated ability to work as both a team player and independently
Display leadership attributes and drive improvement initiatives

Job Responsibility

Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual
Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments
Electronic batch review
GMP Document (SOPs/FORMs) revision review/approval
Review and approval of electronic Maintenance documentation Work Order/Job Plans
Quality support and approval of minor deviations
Electronic Batch Record (MES) documentation revisions and approvals
Evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion
Flexibility with shift work (including weekends) and comfortable with gowning requirements to support 24/7 production in a Grade 8 (Clean Room) Drug Product filling facility

What we offer

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
time-off plans
flexible work models

Fulltime

New

Senior Associate Quality Assurance

The Senior Associate QA will be required to perform 12-hour shift (rotational ni...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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
Preferred 5+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical / biologics industry and understanding of GMP pharmaceutical production, biological drug substance experience and operation
Experience with batch record review, and quality record support
Experience in pharmaceutical equipment operation, design and control including GMP change control
Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
Understanding of equipment log review and continuous monitoring requirements
Good communication skills (technical writing and verbal communication/presentation)
Interacts effectively with variety of communication and working styles
Experience with regulatory audits and inspections
Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality

Job Responsibility

Conduct Quality Assurance activities related to quality floor support for solution and equipment preparation, cell culture and product purification & Drug Substance Filling operations
Support of electronic batch record review and approval, change control, investigations and product release
Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply
Role may include participation in new product introductions, additional equipment, installation commissioning, qualification
Support continuous improving initiatives

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

Snr Associate Manufacturing

As part of Amgen’s Operations organization, Manufacturing continuously strives t...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Working knowledge of aseptic or GMP manufacturing operations
Typically, 2 – 5 years’ experience in a GMP environment
Bachelor’s degree in relevant science or engineering related discipline
Be a results-oriented person with excellent organizational, communicational and team development skills
Demonstrated ability to deliver to team, site and personal objectives
Demonstrated understanding and use of RFT techniques and lean manufacturing concepts
Strong ability to lead, challenge and positively influence in an interactive team environment
Strong computer skills - knowledge of Electronic Batch Records, PAS-X, Lims, etc.

Job Responsibility

Ensuring Safety, Quality and Compliance
Takes a proactive approach to safety, quality and compliance
Contribute to and assist with Corporate, FDA, HPRA and other regulatory bodies during GMP audits
Accountable for ensuring that all staff maintains necessary training qualifications and operate in compliance with SOP’s and to GMP standards
Review manufacturing batch documentation both paper and electronic in a RFT manner
Support deviation management and investigations at various levels
Supporting the shift teams by providing on the floor holiday/ absence cover, problem solving and project support
Supporting the creation of short and medium- schedules and being accountable for the on time in full execution against the plan
Ensuring that appropriate staff levels and trained resources are available at all times to meet the plan
Communicating issues and promptly escalating issues that may jeopardise manufacturing deliverables

What we offer

Total Rewards Plan designed to support your health, financial wellbeing, work/life balance, and long-term career growth
Comprehensive employee benefits package, including 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

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Senior Associate Manufacturing - Electronic Batch Record Support

Job Description

Job Responsibility

Requirements

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Senior Associate Manufacturing - Electronic Batch Record Support

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