Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days

BioSpace; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen North Carolina seeks a Senior Associate Manufacturing - Bulk Drug Substance Downstream to support the facility startup and expansion. You will be hands-on with downstream purification operations including column chromatography, TFF, viral filtration, and activation, ensuring operational readiness and technology transfer.

The role requires coordination across QA/QC, Facilities & Engineering, and production functions, with shifts to support 24/7 manufacturing and startup activities.

Qualifications

• Experience in biotechnology or pharmaceutical plant startups and cGMP environments.
• Knowledge of downstream purification operations and related instrumentation.
• Excellent verbal and written communication (technical) skills.

Responsibilities

• Perform hands-on downstream purification operations and process support.
• Assist in readiness activities for facility expansion and startup.
• Support commissioning, qualification, and startup activities per training.
• Provide operational feedback for safe, compliant manufacturing and continuous improvement.
• Collaborate cross-functionally to ensure equipment, procedures, and workflows are ready.

Skills

column chromatography

TFF

viral filtration

viral inactivation

conjugation

operation readiness

Education

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience

Associates Degree + 2 years manufacturing and/or other regulated environment experience

Bachelors Degree + 6 months manufacturing and/or other regulated environment experience

Master's Degree

Tools

DeltaV

MES

Electronic Batch Records (EBR)

Job description

Join Amgens Mission of Serving Patients

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.

Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days

Live

What you will do

Lets do this! Lets change the world! In this dynamic role, you will be an Senior 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 manufacturingdownstream purification operations including column packing,columnchromatography, TFF,viralfiltration,viralinactivation, conjugation, and final fill,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.

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 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

Operational Readiness & Facility Startup

Support operational readiness activities for facility expansion and startup

Execute manufacturing readiness tasks including equipment preparation, procedure execution, and process walkthroughs

Participate in commissioning, qualification, and startup activities as trained and assigned

Provide operational feedback during startup activities to support safe, compliant, and efficient manufacturing

Support readiness planning through execution of training, procedures, workflows, and operational practices required for startup and rampup

Process/Equipment/Facilities

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

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, ESPs)

Collaborate cross-functionally (i.e., QA/QC, F&E (Facilities & Engineering), PPIC (Production Planning and Inventory Control), 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

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seekis a team player with these qualifications.

Basic 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'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
• Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
• 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

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

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.