Manager Manufacturing (GMP Drug Substance)

About the role

Amgen is looking for a Manager Manufacturing to lead a team of experienced manufacturing associates responsible for producing GMP drug substance at its Singapore manufacturing site in Tuas. The role is an on-shift front-line manager covering day and night shifts on a 12-hour rotation, with responsibility for safe, compliant production and for championing Lean culture and continuous improvement.

Key responsibilities

• Lead floor operations and staff, supervising, coaching, hiring and developing them
• Ensure safe working conditions, cGMP and CFR compliance, and adherence to Amgen policies
• Evaluate operating procedures, recommend improvements, and ensure change control and regulatory notification before changes
• Interact with regulatory agencies and oversee gowning and aseptic techniques
• Work with cross-functional teams (QA/QC, F&E, PPIC, PD, Regulatory) and resolve operational problems
• Supervise staff performance, training, and adherence to production schedules and maintenance
• Take part in budgeting and departmental goal setting

Required profile

• Doctorate, or Master's degree with 2 years' experience in a pharma or GMP environment, or Bachelor's degree with 4 years' experience
• Diploma with 8 years' experience in a pharma or GMP environment
• 4+ years in GMP technical support, engineering or manufacturing support, with at least 3 years in pharma or biotechnology
• Previous managerial experience leading people, teams or projects
• 5 years of process experience in a cGMP manufacturing facility and 3+ years in a production area lead, specialist or manager role

Required skills

• Basic understanding of engineering, biological or chemical processing in a cGMP environment
• Leadership, team building, conflict resolution and analytical problem solving
• Performance management and project management skills
• Technical communication and computer skills with Microsoft, EBR/MES, Delta V and electronic quality systems