Director, Manufacturing Sterile Operations

Responsibilities

• Directs and leads the Manufacturing team to deliver on the schedule of four aseptic isolator fill lines and visual inspection to meet company and client demand.
• Leads manufacturing and cross functional support teams with Lean Six Sigma / continuous improvement mindset and principals to achieve higher quality, compliance, and productivity goals.
• 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.
• Accurately and timely completes all department investigation reports and the effective and timely corrective/preventative action (CAPA) implementations and follow-up.
• Accurately and timely completes all manufacturing processes and documentation (Manufacturing Batch Records and Quality Records) and "Right First Time" performance goals.
• Sets strategic direction and administration of Manufacturing.
• 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.
• Other duties as assigned.

Qualifications

• Bachelor’s degree required (Science or Engineering related preferred).
• 10+ years of CDMO or pharmaceutical experience required, 6+ years of management experience required.
• Prior pharmaceutical experience in sterile aseptic filling and visual inspection is required; prior CDMO experience preferred.
• Strong knowledge of pharmaceutical regulatory requirements and cGMP required.
• Knowledge of quality systems and processes, change control, CAPA and data integrity required.
• Knowledge of aseptic processing of commercial or clinical parenteral products.
• Prior experience with final product release, major equipment validation, validation protocol review, process validation protocol review, 21 CFR Part 4/ISO 13485 and APRs preferred.