Specialist Manufacturing Investigations

Career Category

Manufacturing

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like   you’re   part of something bigger,   it’s   because you are. 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. We are global collaborators who achieve together, researching, manufacturing, and delivering ever-better products that reach over   10 million patients   worldwide.   It’s   time for a career you can be proud of.

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 single use 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.

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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

O r

Master’s degree & 2 years of   directly related   experience

Or

Bachelor’s degree or & 4 years of   directly related   experience

Or

A ssociate’s   degree & 8 years of   directly related   experience

Or

High school diploma / GED & 10 years of   directly related   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 

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

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Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

. Salary Range

107,545.40USD -145,502.60 USD