Senior Associate Manufacturing, Drug Product Job at Amgen (Thousand Oaks)

Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights

Location

United States , Holly Springs

Salary:

Not provided

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

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

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

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

United States , Holly Springs

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

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

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

Senior Associate Manufacturing

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

Quality Assurance Senior Associate, Drug Substance Plant

In this role as Senior Associate QA, you will be responsible for providing quali...

Location

United States , Thousand Oaks

Salary:

86928.00 - 106536.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years quality assurance work experience
Associate’s + 2 years quality assurance work experience
Bachelor’s + 6 months quality assurance work experience
Master's
Quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field
Ability to successfully manage workload to timelines
Familiarity with basic project management tools
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment

Job Responsibility

Provide daily guidance and support to Production staff on compliance with Standard Operating Procedures (SOPs) and Work Instructions
Maintain a strong presence in Drug Substance (DS) areas to oversee GMP operations and quality systems
Serve as the first point of contact for quality-related production queries during DS operations
Lead, mentor, and coach Operations and support personnel on quality matters, fostering a strong Quality culture at the site
Review and approve batch production records and other GMP documentation to support daily operations
Compile and review batch records for manufactured lots in preparation for batch disposition
Own, review, and approve controlled documents, including SOPs, Work Instructions, and Forms
Collaborate effectively within a team matrix environment
Work across a three shift rotation including night shift

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 – Single Use Systems (SUS)

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School/GED and 4 years of manufacturing or operations work experience
Associate’s Degree and 2 years of manufacturing or operations work experience
Bachelor’s Degree and 6 months of manufacturing or operations work experience
Master’s Degree
Experience with and understanding of Single-Use Systems
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

Job Responsibility

Support New Product introduction and projects through SUS mapping/drawing
Maintain and edit SUS Standard Operating Procedures (SOP)
Support manufacturing and quality through the SUS defect/leak triage process – perform troubleshooting on the floor, initiate investigations and bring leaks and defects to triage meetings
Initiate Event Notification (EN)/Supplier Investigation/Corrective Action (SICAR) records and follow process to conclusion, including collaborating with vendors on investigation
Maintain up-to-date EN/SICAR/Early Engagement (EE=new item) trackers and manage or lead small to medium projects
Provide input for ANC representative to SUS network for improvements and troubleshooting
Support Vendor Change Notification assessments
Understand single-use material capabilities and user requirements for new technologies through interaction with end users
Collaborate with Continuous Improvement (CI) leads to help SUS improvement projects and provide/lead use cases for continuous improvement projects. For example, improvements around tubing management, material kitting and flow

What we offer

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

Fulltime

Senior 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

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

Process Development Senior Associate

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States , Cambridge

Salary:

85306.00 - 103484.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree or (foreign equivalent) in Chemical Engineering, Bioengineering, Analytical Chemistry, Biochemistry or a related field & completion of a university-level course, research project, internship, thesis, or one year of experience in the following: 1. Analytical chemistry experience for small molecules, and completion of project deliverables including: designing and conducting targeted metabolomics experiments, extracting and analyzing results via dedicated software: ChemStation, MassHunter, or MassAnalyzer
2. Analytical method development (chromatography and mass spectrometry), related technologies and instrumentation including: U/HPLC, GC, or LC-MS
3. Method qualification and transfer for analytical instruments, along with data analysis and statistical evaluation of experimental results
4. Application analytical instrument troubleshooting across different platforms: Waters, Agilent, or Sciex, and problem solving of such technologies
5. Implementing Standard Operating Procedures in a laboratory environment in accordance with GLP standards
and 6. Maintaining a laboratory notebook.

Job Responsibility

Conduct experiments, analyze results, and implement process improvements to enhance efficiency and product quality
Design, develop, and optimize manufacturing processes
Collaborate closely with a team of analysts and scientists
Responsible for the technical aspects of developing analytical tools to gain understanding of quality attributes in product and process for late phase synthetic small molecule, synthetic peptide, and siRNA programs
Utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application
Develop, optimize, and execute analytical methods for synthetic small molecules, synthetic peptide, and SiRNA release testing and process characterization
Collaborate closely with drug substance process development team to achieve project objectives and provide analytical data to support drug substance product development.

What we offer

stock
retirement
medical
life and disability insurance
eligibility for an annual bonus
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

Fulltime

Select Country

Senior Associate Manufacturing, Drug Product

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?

Senior Associate Manufacturing, Drug Product

Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights

Senior Associate Manufacturing - Bulk Drug Substance Downstream

Senior Associate Manufacturing

Senior Associate, Manufacturing

Quality Assurance Senior Associate, Drug Substance Plant

Senior Manufacturing Associate – Single Use Systems (SUS)

Senior Associate Manufacturing

Process Development Senior Associate

Our AI answers in your language