Senior Associate - Bulk Drug Substance Manufacturing Services - Days
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Job summary
Amgen North Carolina is seeking a Senior Associate for Bulk Drug Substance Manufacturing Services to support the ANC2 facility expansion and startup. You will assist weigh and dispense of materials, media, buffers, and solution preparation, and help with equipment setup and process documentation in a cGMP environment.
You will collaborate across QA/QC, Facilities & Engineering, PPIC, Mfg., and Regulatory teams to enable readiness and continuous improvement.
Qualifications
- High School Diploma/GED + 4 years manufacturing or regulated environment experience.
- Associates Degree + 2 years manufacturing or regulated environment experience.
- Bachelor's Degree + 6 months manufacturing or regulated environment experience.
- Master's Degree (any related field).
Responsibilities
- Set up, clean, sanitize and monitor equipment and area.
- Run critical process tasks and document results in EBRs.
- Assist in startup, qualification and readiness activities.
- Support training and qualification of staff.
- Maintain compliance with cGMP and safety requirements.
Skills
Education
Tools
Job description
HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, if you feel like youre part of something bigger, its because you are. Our sharedmissionto servepatientslivingwithseriousillnessesdrivesallthatwe do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
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.
Lets do this. Lets change the world! In this dynamic role, you will be a Senior Associate in the Manufacturing organization at Amgen North Carolina (ANC), supporting the ANC2 facility expansion and startup program. This essential role will be part of the Services team responsible for enabling manufacturing operations through weigh and dispense of raw materials, material receiving and handling, media, buffer, and solution preparation, and component preparation activities, including parts washing and autoclave operations.
As a Senior Associate, you will provide technical and operational support to the Services area, help coordinate daily activities, support training and qualification of staff, and promote safe, compliant, and reliable execution. You will partner across functions to support successful operational readiness, technology transfer, facility startup, and the ramp-up of manufacturing operations within the new facility.
This role may require work outside standard business hours, including non-standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. During this phase of startup, you will be expected to work a Monday through Friday schedule from 8:00 a.m. to 5:00 p.m. As the business transitions from C&Q to manufacturing operations, this essential position will move to a 12-hour, 2-2-3 schedule from 5:45 a.m. to 6:15 p.m., supporting critical 24/7 manufacturing operations.
Because Amgen relies on the regular attendance of all staff members to meet legitimate business needs, individuals in this role must be able to work their assigned 12-hour shift, including during inclement weather, on some holidays, and during requested overtime in support of operations.
During the early phases of the project, this role will focus on operational readiness, training, procedure development, equipment and process familiarization, startup execution, and coordination of Services activities. As the facility transitions to steady-state operations, the role will shift toward routine manufacturing execution, oversight of daily floor activities, troubleshooting, coaching and development of staff, cGMP documentation, and continuous improvement.
With general direction, the Senior Associate will support and help lead Services floor operations in accordance with current Good Manufacturing Practices (cGMP), applicable procedures, safety requirements, and established production schedules.
- Completes 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 deviation reports
- 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 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
- Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions
- Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs)
- Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
- Responsible for recognizing and elevating problems during daily operations
- Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement
- Drive safety in all operations, and assist the manager in escalating concerns as needed
- Maintain an organized, clean, and workable space
- Draft and revise documents (SOPs, technical reports, and MPs)
- Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process
We are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seek is a team player with these qualifications.
- High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
- Or
- Associates Degree + 2 years manufacturing and/or other regulated environment experience
- Or
- Bachelors Degree + 6 months manufacturing and/or other regulated environment experience
- Or
- Master'sDegree
- Completion of NC BioWorks Certification Program
- Experience in biotechnology or pharmaceutical plant start up
- Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
- Strong understanding of solution preparation, equipment preparation, and inventory control operations
- 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
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.
- 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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