Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days

NCBioImpact; Holly Springs (NC); Hybrid; USD 86,000 - 116,000; Full time

Benefits offered by this job

Flexible work model

Job summary

Amgen North Carolina (ANC) is seeking a Senior Associate in Downstream Manufacturing for the day shift, with possible work-from-home arrangements. The role focuses on on-the-floor cGMP manufacturing of drug substance in Manufacturing Services and requires collaboration with QA/QC, F&E, PPIC, and other teams to ensure compliance and high-quality output.

The initial schedule is Monday–Friday, 8-hour days, with potential transition to 12-hour day or night shifts as needed to meet business demands.

Qualifications

• Excellent verbal and written communication (technical) skills.
• Proficient Microsoft Office skills; knowledge of EBR/MES, Delta V, and Electronic Quality Systems.

Responsibilities

• Complete SOPs, MPs and CFR-aligned tasks with strict safety/compliance.
• Initiate deviation reports and interact with regulatory guidance as needed.
• Assist in review of equipment logs, EBRs and related docs.
• Collaborate with QA/QC, Facilities & Engineering, PPIC, Mfg., PD and Regulatory on production activities.
• Drive safety, identify issues, and contribute to CAPAs for continuous improvements.

Skills

Excellent verbal and written comms (te

Education

High School Diploma/GED

Associate’s Degree

Bachelor’s Degree

Master’s Degree

Tools

DeltaV

MS Office

Electronic Quality Systems

EBR/MES

Job description

Career Category

Manufacturing

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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.

Senior Associate Downstream Manufacturing (Day Shift)

What you will do

Let’s do this. Let’s change the world. In this dynamic role, you will be a Senior Associate in the manufacturing organization at Amgen North Carolina (ANC). The initial schedule will be Monday-Friday, 8-hour days, and may include work from home. The schedule will transition to a 12-hour day or night shift as business needs dictate. The Senior Associate will be executing operations on the floor in Manufacturing Services areas and is responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.

With general direction, the Senior Associate is responsible for executing on-the-floor operations within manufacturing in accordance with cGMP practices.

Responsibilities will include…

Compliance:

• 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

Process/Equipment/Facilities:

• 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

Administrative:

• 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

What we expect of you

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.

Basic Qualifications:

• 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

Preferred Qualifications:

• 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

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

Salary Range

86,048.05USD -116,417.95 USD