Specialist Manufacturing – Investigations

Amgen • Holly Springs, NC

4d

About The Position

Amgen is hiring a Specialist Manufacturing – Investigations for its North Carolina Biologics Drug Substance Manufacturing plant, part of the FleX batch facility. The facility will combine single-use technologies and traditional stainless steel equipment, include embedded Industry 4.0 capabilities, and incorporate sustainability innovations intended to reduce carbon and waste.

In this role, you will investigate major deviations, working between GMP manufacturing teams and stakeholders in Process Development, Facilities & Engineering, Automation, EHSS, and Quality. You will ensure investigations are conducted and documented successfully, while improving the investigation process. The position requires leading cross-functional teams through complex investigations, communicating findings and progress to impacted groups and leadership, and supporting collaboration through Operational Learning Team strategies.

Requirements

• Doctorate degree; or a master's degree and 3 years of directly related experience; or a bachelor's degree and 5 years of directly related experience; or an associate's degree and 10 years of directly related experience; or a high school diploma/GED and 12 years of directly related experience.
• Background in biologics drug substance manufacturing and investigations.
• Strong cross-functional project management and communication skills.

Nice To Haves

• At least 5 years of related work experience in manufacturing, process development, or quality assurance in the biotech or pharmaceutical industry, with progressively increasing responsibility.
• Experience with compliance, problem-solving, simple and complex root cause analysis tools (including 5 Whys, fishbone, Kepner Tregoe Problem Analysis, and Design of Experiment), 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, developing CAPAs, and documenting findings compliantly.
• Drive improvements to the investigation process.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Communicate investigation progress clearly to impacted areas and leadership.
• Coordinate and lead cross-functional teams through complex investigations and complete milestones on schedule.
• Present complex topics to groups of varying sizes and levels, and understand and communicate complex issues clearly.
• Build effective relationships across functions.
• Navigate ambiguity and apply a structured problem-solving approach.
• Apply inductive and deductive reasoning in investigations.
• Produce clear and concise technical writing.
• Use Operational Learning Team strategies to promote open collaboration with staff and maximize investigation findings.
• Develop tracking tools to support 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.
• Discretionary annual bonus program.
• 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.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed