Manager, Sterile Fill Manufacturing - 3rd Shift

Responsibilities

• Develops information and produces reports concerning scheduling, production goals, equipment and maintenance problems and other studies or reports as requested.
• Provides manufacturing information by compiling, initiating, sorting, and analyzing production related records and data to key stakeholders within Alcami.
• Safeguards all manufacturing discrepancies by capturing them with appropriate documentation and collaborating with appropriate personnel to facilitate client communication per quality agreements.
• Ensures the accurate and timely completion of all department investigation reports and CAPA implementations and follow-up.
• Guarantees the accurate and timely completion of all manufacturing processes and documentation (batch records) and "first time right" performance goals.
• Administers the department budget to include forecasting resources for future periods.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.

Qualifications

• Bachelor’s degree required and a minimum of 8 years of related experience required.
• A minimum of 4 years of supervisory experience is required.
• Prior pharmaceutical experience, CMO or CDMO experience required.
• Aseptic filling experience required.
• Expert knowledge of reviewing/approving manufacturing investigations ensuring they are completed in a timely manner with appropriate root cause analysis and effective corrective/preventative action identified required.
• Expert knowledge of supporting the development of new or revised manufacturing instructions preferred.
• Knowledge of operational procedures for equipment preparation, formulation, filing, capping and lyophilization activities within their respective cGMP guidance/procedures required.
• Knowledge of leading manufacturing teams to maintain adherence to a demanding production schedule required.
• Strong computer skills.