Specialist - Manufacturing Investigations

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.

Specialist - Manufacturing Investigations Live What you will do Let’s   do this. Let’s   change the world. In this vital role, you will be a key member of the team that investigates   major   d eviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant.

You will communicate and interface between the GMP manufacturing teams and   stakeholder groups   including,   Process Development ,   Facilities &   Engineering,   Automation, EHS S, and   Quality . This position   is responsible for   ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

Responsibilities

include:

• Manage   Major   deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
• Drive improvements to the investigation process .
• Present investigations to regulatory inspectors, internal auditors, and management .
• Clearly communicate investigation progress to   impacted   areas and leadership .
• Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
• Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
• Build effective relationships across functions.
• Navigate through ambiguity and provide a structured problem-solving approach.
• Apply inductive and deductive reasoning in the investigation process
• Clear and concise technical writing
• Use   O perational   L earning   T eam strategies to   promote open collaboration with staff   to   maximiz e   investigation findings .
• Develop   tracking tools to ensure on-time closure and proactive   review   of deviation investigations. ​ Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we   seek   has a   biologics   Drug Substance manufacturing and   investigation s   background with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications

• Doctorate degree OR
• Master’s degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience or
• Bachelor’s degree and 5 years of biotechnology operations experience or
• Associate’s degree & 10 years of biotechnology operations experience or
• High school diploma / GED & 12 years of biotechnology operations experience

Preferred Qualifications

• 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
• Experience with compliance, problem-solving,   simple and complex   root cause analysis   tools (5-whys, fishbone, Kepner Tregoe   Problem   Analysis ®, Design of Experiment etc.)   critical thinking, project management, and quality systems.
• Degree in Science or Engineering
• Experience leading complex investigations
• Experience using   Veeva   QMS   for Deviation investigations and CAPAs
• Demonstrated project management ability
• Experience presenting to inspectors during regulatory inspections and internal audits.
• Excellent written and verbal communication skills
• Ability to work in a team matrix environment and build relationships with partners
• Strong interpersonal skills 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 annual base salary range for this opportunity in the U.S. is provided below. In addition to the base salary, 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 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. #AmgenNorthCarolina .

Salary Range 107,545.40USD -145,502.60 USD