Director, Manufacturing Operations

Overview

The Director of Manufacturing Operations organizes, manages, and continuously improves the manufacturing operations and processes for the manufacturing site in Philadelphia, PA. This position is directly responsible for the operational teams that support clinical or commercial manufacturing as a value stream. The Director of Manufacturing Operations guides and oversees the process and production, ensuring material is made safely and compliant and meets company targets. The Director is also responsible for developing a strategy to accommodate the company’s needs within the operations space as a growing organization.

Essential Functions and Responsibilities:

• Coordinate the initial production plan for clinical or commercial material annually that meets strategic objectives and complies with cGMPs and safety regulations.
• Help develop schedules for manufacturing that meet monthly and quarterly targets. Ensure workforce resources are adequate to complete operations and fully optimized from an operational excellence perspective.
• Lead critical-level investigations related to the manufacturing and initial validation steps. Approve deviations, non-conformances, and CAPAs as required. Partner with Quality 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.
• 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 that motivates a diverse team to fully use its capabilities in achieving the desired business results.
• Must adhere to Company’s Biotherapeutics’ 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. in biochemistry, chemical engineering, bioengineering, 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 of aseptic processing in cleanroom environments is a must.
• Strong technical writing ability is required.
• Ability to motivate and mentor peers and staff and foster a culture of continuous improvement and operational excellence.
• Self-motivated and willing to accept temporary responsibilities outside the 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.
• Expert level in visual management, KPIs, huddle boards, etc.

Preferred Education, Skills, and Knowledge:

• Cell and gene therapy experience is preferred.