Specialist Manufacturing Drop Substance

Responsibilities

• Serve as a subject matter expert for manufacturing processes, equipment, systems, and CAPA management.
• Own and maintain SOPs, batch records, deviations, and technical documentation to ensure cGMP compliance.
• Lead troubleshooting efforts for complex process or equipment issues using root cause analysis.
• Monitor manufacturing data and KPIs to identify trends, risks, and opportunities for improvement.
• Drive continuous improvement by exploring new technologies and digital tools to enhance efficiency.
• Provide formal training and mentorship to team members on complex manufacturing processes and systems.
• Represent the manufacturing department in cross-functional meetings, audits, and investigations.
• Manage change controls and projects related to process optimization and quality standards.

Requirements

• Doctorate degree; OR Master’s degree and 2 years of Manufacturing/Quality Support experience; OR Bachelor’s degree and 4 years of experience; OR Associate’s degree and 8 years of experience; OR High school diploma/GED and 10 years of experience.
• Background in Life Sciences or Engineering.
• Proficiency in Good Documentation Practices (GDP) within a regulated environment.
• Strong technical writing and presentation skills.
• Ability to communicate effectively in English and Spanish.

Preferred Qualifications

• In-depth experience with bio-processing unit operations.
• Knowledge of Root Cause Analysis methodologies (e.g., Fishbone, 5 Whys, Kepner Tregoe).
• Familiarity with Lean Manufacturing practices.
• Experience with systems such as Trackwise, VEEVA, MES, Power BI, or Spotfire.

Benefits

• Comprehensive health, dental, and vision coverage.
• Retirement and Savings Plan with generous company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and an annual site shutdown.

About the Company

Amgen is a leading biotechnology company dedicated to discovering, developing, and manufacturing innovative human therapeutics. Since 1980, Amgen has focused on serving patients living with serious illnesses in therapeutic areas including Oncology, Inflammation, General Medicine, and Rare Disease.