Specialist Manufacturing – Investigations

Amgen SA; Holly Springs (NC); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models

Medical, dental, vision coverage

Retirement plan

Stock-based incentives

Time-off programs

Job summary

Amgen North Carolina is seeking a Specialist-Manufacturing Investigations to join the biologics operations team. You will investigate major deviations in the NC Biologics Drug Substance plant, interfacing with GMP manufacturing, Process Development, Facilities & Engineering, Automation, EHSS, and Quality to ensure investigations are thorough and well-documented.

The role requires extensive root-cause analysis, project management, and strong technical writing, with opportunities to present

Qualifications

• Biologics Drug Substance manufacturing and investigations background.
• Experience with compliance, problem-solving, root cause analysis tools.
• Experience presenting to inspectors during regulatory inspections.

Responsibilities

• Manage major deviation investigations, assemble teams, lead root cause analysis, develop CAPAs.
• Drive improvements to the investigation process and timing.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Communicate progress to leadership and impacted areas.
• Lead cross-functional teams through complex investigations and meet milestones.
• Communicate complex topics clearly to varied audiences.
• Build relationships across functions and navigate ambiguity.
• Apply inductive and deductive reasoning; write concise technical documents.
• Develop tools to track on-time closure and proactive review of investigations.

Skills

Biologics manufacturing

Root cause analysis

Project management

Cross-functional collaboration

Regulatory inspection experience

Technical writing

Communication skills

Teamwork in matrix environment

Education

Doctorate degree

Master’s degree + 3 yrs related experience

Bachelor’s degree + 5 yrs related experience

Associate’s degree + 10 yrs related experience

High school diploma + 12 yrs related experience

Tools

Veeva QMS

CAPA tools

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 deviations 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, EHSS, 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 Operational Learning Team strategies to promote open collaboration with staff to maximize 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 investigations background with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree & 3 years of directly related experience

Or

Bachelor’s degree or & 5 years of directly related experience

Or

Associate’s degree & 10 years of directly related experience

Or

High school diploma / GED & 12 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

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