Manager Manufacturing - GMP Drug Substance

About the role

Amgen is looking for a Manager Manufacturing to act as the on-shift front-line manager for day and night shifts (12-hour rotation). The role leads a team of experienced manufacturing associates responsible for producing GMP drug substance, champions a safe and compliant production environment through structured on-floor presence, and acts as an active participant and role model in Lean culture and continuous improvement.

Key responsibilities

• Lead on-floor operations and staff, supervising, coaching, hiring and developing them
• Define area objectives, identify improvement opportunities and lead change efforts to meet operational goals
• Ensure safe working conditions, cGMP and CFR compliance, and adherence to Amgen policies
• Evaluate operating procedures, recommend changes, and ensure change control procedures are followed with Regulatory and QA notified
• Interact with regulatory agencies and ensure proper gowning and aseptic techniques
• Work with cross-functional teams (QA/QC, F&E, PPIC, Mfg, PD, Regulatory) and resolve problems during operation
• Oversee setup and completion of critical manufacturing processes
• Manage staff performance, selection, training, evaluation and development, and maintain training programs
• Ensure adherence to production schedules and maintenance activities, audit and evaluate plant safety, and help plan budgets and department goals

Required profile

• Doctorate, or Master's degree with 2 years' experience in a pharmaceutical or GMP environment, or Bachelor's degree with 4 years' experience
• Diploma with 8 years' experience in a pharmaceutical or GMP environment
• 4+ years in GMP technical support, engineering or manufacturing support, with at least 3 years in pharmaceutical or biotechnology
• 5 years of process experience in a cGMP manufacturing facility
• 3+ years in a production area lead, specialist or manager role
• Previous direct people management or team leadership experience

Required skills

• Knowledge of cGMP and highly regulated environments
• Leadership, team building, coaching and mentoring
• Performance management, conflict resolution and analytical problem solving
• Project management and regulatory requirements
• Technical communication and computer skills with Microsoft, EBR/MES, Delta V and electronic quality systems