Senior Associate Manufacturing

New

Senior Associate Manufacturing I

In this role you will be managing and leading all aspects of a device assembly &...

Location

United States , New Albany

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience
Or Associate’s + 2 years biotech or pharmaceutical manufacturing, process development or quality experience
Or Bachelor’s + 6 months biotech or pharmaceutical manufacturing, process development or quality experience
Or Master's

Job Responsibility

Managing and leading all aspects of a device assembly & packaging line
Maintaining production in full cGMP compliance
Assisting with supervising and developing technicians while overseeing production equipment to ensure production schedules are completed
Leading manufacturing operations on the production floor while helping to perform equipment setup, operation and troubleshooting
Maintaining machine uptime, perform any fault clearing and clear stoppages on automated equipment
Ensuring all safety and compliance procedures are followed at all times
Raising appropriate concerns to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk
Providing training to manufacturing staff on process and equipment
Providing troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor
Collaborating with Quality, Engineering and Manufacturing Support to resolve manufacturing events in a timely manner

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

Senior Manufacturing Associate

This position supports contamination control, inspection readiness and process s...

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
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

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

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

Senior Manufacturing Associate

This position supports contamination control, inspection readiness and process s...

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
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

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

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

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Thousand Oaks

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

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

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

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

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

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

Global Product Manufacturing Lead, Booking Services- SVP

The Global Core Trade Product Manufacturing sits within the Global Core Trade Pr...

Location

United Kingdom , London

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Experience: Extensive experience in Trade Finance, Transaction Banking, or a related product management/manufacturing role
Trade Knowledge: A strong understanding of core trade finance products, end-to-end operational processes, and associated systems. Familiarity with Citi's policies and procedures is highly advantageous
Project Management: Proven track record of managing and delivering large-scale, complex projects, including both technology and non-technology initiatives
Education: Bachelor's degree required. An MBA or other advanced degree is preferred.

Job Responsibility

Define the future operating model for Core Trade financial products to improve profitability and simplify customer demands
Identify opportunities to build new products and modernize infrastructure by standardizing complex processes
Drive strategic capital management objectives, including significant contributions to Risk-Weighted Asset (RWA) reduction
Measure performance against industry peers to ensure our offerings remain best-in-class
Define and implement Target Operating Models (TOM) for Core Trade products
Continuously drive productivity enhancements and improve operational efficiency ratios
Lead initiatives to streamline and automate processes, reducing manual touchpoints and operational risk
Drive Straight Through Processing (STP) initiatives for payments to increase speed and accuracy
Develop and implement advanced Auto-Reconciliation and Settlement capabilities
Integrate innovative FX solutions to enhance product offerings and client value

Fulltime

Select Country

Senior Associate Manufacturing - Continuous Improvement Lead

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?

Senior Associate Manufacturing - Continuous Improvement Lead

Senior Associate Manufacturing I

Senior Manufacturing Associate

Senior Manufacturing Associate

Senior Associate Manufacturing

Senior Associate, Manufacturing

Senior Associate Manufacturing, Upstream - Days

Senior Manager / Associate Director, Manufacturing

Global Product Manufacturing Lead, Booking Services- SVP

Our AI answers in your language