Overview
The Director of Manufacturing Operations organizes, manages, and continuously improves the manufacturing operations and process for the manufacturing site. This individual is directly responsible for the operational teams that support clinical or commercial manufacturing as a value stream. This individual guides and oversees the process and production, ensuring material is made safely and compliant and meeting company targets. The Director is also responsible for developing a strategy to accommodate needs within the operations space as a growing organization.
Day shift: Monday to Friday from 7:30am-4:00pm
Essential Functions and Responsibilities
• Coordinate the initial production plan for clinical or commercial material on an annual basis that meets strategic objects and is compliant with cGMPs and safety regulations.
• Help develop schedules for manufacturing that meet monthly and quarterly targets. Ensure manpower resources are adequate to complete operations and fully optimized from an operational excellence perspective.
• Lead critical level investigations as related to the manufacturing and initial validation steps. Approve deviations, non-conformances, and CAPAs as required. Partner with Quality to and MSAT to address these issues effectively and compliantly.
• Participate in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.
• Develop and provide monthly manufacturing metrics and “Health of the Operations”
• Identify and implement continuous improvement opportunities for process and production related items. Expertise level in visual management, KPIs, huddle boards etc.
• Ensure the effective application of internal control systems and procedures applicable to each functional area of responsibility by providing management direction to operations personnel.
• Provide leadership to ensure the organization attracts, trains, develops and retains the best people and fosters an environment which motivates a diverse team to fully use its capabilities in achieving the desired business results
• Must adhere to core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
• Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
• At least 12 years of relevant operations experience for clinical and commercial production in the life sciences industry.
• A minimum of 10 years in a supervisory role, with increasing responsibility. Ability to manage and influence large teams within the manufacturing environment (potentially 50+ employees)
• Solid knowledge of FDA regulations and GMP systems.
• Solid knowledge of human error reduction strategies, right-first time execution, and just culture.
• Demonstrated technical knowledge aseptic processing in cleanroom environments a must.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Project management skill set with experience in strategic/tactical planning, team building and meeting budgets.
Preferred Education, Skills, and Knowledge
• Cell and gene therapy experience is preferred.
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