Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights

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   Manufacturing   -  Bulk Drug Substance Downstream   -   Nights Live 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 essential position, which supports our critical 24/7 manufacturing operations,  works  a 12-hour 2-2-3 schedule from 5:45 p m   to   6:15 a m. Associates will be executing operations on the floor   in our downstream          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.

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
• I nitiate quality non-conformance (NC) reports
• I nteract with regulatory agencies as   needed and   guided
• Assure proper gowning and aseptic techniques are   always followed Process/Equipment/Facilities:
• U nderstanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
• Perform hands-on   downstream biotech   operations   (Column Chromatography, T angential Flow Filtration , Viral Filtration, Viral Inactivation , Column Packing among others )   including set-up,   operation,   cleaning, sanitization,   monitoring   of equipment and assigned area
• Run   and   monitor   critical proces s tasks   per   assigned procedures
• Perform in-process sampling,   operate   analytical equipment, and   complete   process documentation   ( E lectronic   B atch   R ecords   [ EBR ])
• Complete   washroom activities :   cleaning equipment, small to large scale, used in production activities
• Initiate and own manufacturing related   process   deviations
• Identify , recommend, and implement innovat iv e 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   escalat ing   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   seek   is a   team player with these qualifications.

Basic Qualifications

• High   S chool   Diploma /GED + 4   years   m anufacturing and/or   other   regulated   environment   experience Or​
• Associate’s   Degree   + 2 years   m anufacturing and/or   other   regulated environment experience Or​
• Bachelor’s   Degree   + 6 months   m anufacturing 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
• U nderstanding 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 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. .

Salary Range 86,048.05USD -116,417.95 USD