Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days

Career Category Manufacturing

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll 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.

Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days

What you will do

Let’s do this! Let’s change the world! In this dynamic role, you will be a Sr Associate in the manufacturing organization at Amgen North Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45am to 6:15pm. Associates will be executing operations on the floor in our upstream area and will be responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substances.

With general direction, the Senior Associate is responsible for executing on-the-floor operations within manufacturing in accordance with cGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.

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

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

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 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

Preferred Qualifications:

• Completion of NC BioWork Certificate Program

• Experience in biotechnology or pharmaceutical plant start up

• Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment

• Basic understanding of Upstream operation (Vial Thaw, Inoculation/Cell Expansion, Single Use Bioreactor, Production Bioreactor, ATF, Harvest Centrifuge, Depth Filtration)

• 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 your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Salary Range