Specialist - Manufacturing Investigations
About The Position
Amgen is seeking a Specialist - Manufacturing Investigations to join their newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This facility combines the latest disposable technologies with traditional stainless-steel equipment for maximum operational flexibility and integrates industry 4.0 capabilities and sustainability innovations. The role is crucial for investigating major deviations in the Biologics Drug Substance Manufacturing plant, ensuring successful and compliant documentation of investigations, and driving improvements in the investigation process. The Specialist will interface between GMP manufacturing teams and various stakeholder groups, including Process Development, Facilities & Engineering, Automation, EHSS, and Quality.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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.
Benefits
- 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
