What are the responsibilities and job description for the Associate Manufacturing - Bulk Drug Substance Upstream - Days position at BioSpace?
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Associate Manufacturing - Bulk Drug Substance Upstream - Days
Live
What you will do
Lets do this! Lets change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC)supporting the facility expansion program and facility startup. Thisessentialrole will be part of a team responsible for manufacturingcell cultureoperationsincluding seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation,while partnering across functions to ensure successful operational readiness, technology transfer, and rampup of manufacturing operations within the new facility.
This role may require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.During this phase of thestartup, you will be expected toworkaMonday Friday schedule from 8am 5pm.As the business moves from C&Q to manufacturing operations, this essential positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting our critical 24/7 manufacturing operations.As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, this role must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our operations.
During early phases, this role will focus on operational readiness, training, and startup execution. As the facility transitions to steadystate operations, the role will shift toward routine manufacturing execution and continuous improvement.
With general direction, the Associate will support all floor operations in accordance withcGMP practices.
Key Responsibilities
Compliance & Quality
Execute work in accordance with established cGMP procedures and policies, including SOPs, MPs, JHAs, and applicable CFRs
Ensure proper gowning and aseptic techniques are consistently followed
Initiate and document manufacturingrelated deviations and quality events as trained
Support investigations and corrective actions under guidance
Maintain a strong culture of safety, quality, and compliance
Operational Readiness & Facility Startup
Support operational readiness and facility startup activities as part of the expansion program
Participate in training, equipment familiarization, and procedure execution to enable startup
Execute assigned readiness tasks supporting commissioning, qualification, and early manufacturing operations
Follow defined workflows and procedures to support safe and compliant startup activities
Provide operational feedback and escalate issues observed during startup execution
Manufacturing Operations
Perform hands-on manufacturing operations including setup, operation, monitoring, cleaning, and sanitization of equipment and assigned areas
Run and monitor critical process tasks per approved procedures
Perform inprocess sampling, operate analytical equipment, and complete Electronic Batch Records (EBRs)
Complete washroom activities for small to largescale manufacturing equipment
Identify and escalate operational issues impacting safety, quality, or schedule
Maintain an organized, clean, and compliant manufacturing environment
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.
Basic Qualifications
High School/GED 2 years manufacturing and/or other regulated environment experience
Or
Associates Degree 6 months manufacturing and/or other regulated environment experience
Or
Bachelors Degree
Preferred Qualifications
Completion of NC BioWork / BioWorks Certification Program
Experience in a regulated industry such as biotechnology or pharmaceutical manufacturing
Basic understanding of cGMP manufacturing environments
Familiarity with EBR/MES, DeltaV, and electronic quality systems
Strong verbal and written communication skills
Demonstrated desire to learn, grow, and develop manufacturing skills
Ability to work effectively in a team-based manufacturing environment
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen Offers a Total Rewards Plan Comprising Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities Including
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
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
#AmgenNorthCarolina
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Associate Manufacturing - Bulk Drug Substance Upstream - Days
Live
What you will do
Lets do this! Lets change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC)supporting the facility expansion program and facility startup. Thisessentialrole will be part of a team responsible for manufacturingcell cultureoperationsincluding seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation,while partnering across functions to ensure successful operational readiness, technology transfer, and rampup of manufacturing operations within the new facility.
This role may require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.During this phase of thestartup, you will be expected toworkaMonday Friday schedule from 8am 5pm.As the business moves from C&Q to manufacturing operations, this essential positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting our critical 24/7 manufacturing operations.As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, this role must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our operations.
During early phases, this role will focus on operational readiness, training, and startup execution. As the facility transitions to steadystate operations, the role will shift toward routine manufacturing execution and continuous improvement.
With general direction, the Associate will support all floor operations in accordance withcGMP practices.
Key Responsibilities
Compliance & Quality
Execute work in accordance with established cGMP procedures and policies, including SOPs, MPs, JHAs, and applicable CFRs
Ensure proper gowning and aseptic techniques are consistently followed
Initiate and document manufacturingrelated deviations and quality events as trained
Support investigations and corrective actions under guidance
Maintain a strong culture of safety, quality, and compliance
Operational Readiness & Facility Startup
Support operational readiness and facility startup activities as part of the expansion program
Participate in training, equipment familiarization, and procedure execution to enable startup
Execute assigned readiness tasks supporting commissioning, qualification, and early manufacturing operations
Follow defined workflows and procedures to support safe and compliant startup activities
Provide operational feedback and escalate issues observed during startup execution
Manufacturing Operations
Perform hands-on manufacturing operations including setup, operation, monitoring, cleaning, and sanitization of equipment and assigned areas
Run and monitor critical process tasks per approved procedures
Perform inprocess sampling, operate analytical equipment, and complete Electronic Batch Records (EBRs)
Complete washroom activities for small to largescale manufacturing equipment
Identify and escalate operational issues impacting safety, quality, or schedule
Maintain an organized, clean, and compliant manufacturing environment
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.
Basic Qualifications
High School/GED 2 years manufacturing and/or other regulated environment experience
Or
Associates Degree 6 months manufacturing and/or other regulated environment experience
Or
Bachelors Degree
Preferred Qualifications
Completion of NC BioWork / BioWorks Certification Program
Experience in a regulated industry such as biotechnology or pharmaceutical manufacturing
Basic understanding of cGMP manufacturing environments
Familiarity with EBR/MES, DeltaV, and electronic quality systems
Strong verbal and written communication skills
Demonstrated desire to learn, grow, and develop manufacturing skills
Ability to work effectively in a team-based manufacturing environment
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen Offers a Total Rewards Plan Comprising Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities Including
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
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
#AmgenNorthCarolina
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.