Investigations Manager

Investigations Manager

Requirements

• A minimum of a bachelor’s degree in science or related field or equivalent experience required. Advanced degree preferred.
• A minimum of 10 years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years of people leader experience. Cell/Gene Therapy cGMP manufacturing experience preferred.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
• Clear and succinct verbal and written communication skills.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Basic project management skills, responsiveness to issues, and demonstrated passion for creating new medicines.
• Experience with Operational Excellence and/or Lean Manufacturing.
• Experience in Pharmaceutical Manufacturing operations and effectively leading a team.
• Experience in Aseptic Manufacturing or CAR-T manufacturing operations is a plus.

Responsibilities

• Individual will lead a team to support manufacturing investigations, capacity planning, hiring, development, and performance management of its direct reports.
• Monitor day to day execution of investigations, maintain investigations metrics and take necessary actions to sustain metrics targets. Reports to management on trending and status as requested. Identify and implement process improvements related to investigations cycle time, closures, quality, and compliance.
• Develop strategies to increase investigations output while maintaining investigations quality. As needed, review investigations to ensure consistent quality standards are maintained.
• Responsible to meet investigations batch release metrics targets. Drive batch impacted investigations to root cause to meet critical release windows. Provide technical expertise to help identify true root cause of investigations and assess product quality impact.
• Work closely with cross-functional teams to improve/streamline investigations process, manage escalations, assess compliance risks due to investigations observations, and findings related to manufacturing activities of the site.
• Recommend/Implement corrective and preventative measures aimed at improving compliance and reducing repeat occurrences. Follow up to determine if corrective actions adequately addressed root cause of NC event.
• Identify potential compliance issues and opportunities for process improvement. Partner with all operations work-cells to implement process improvements. Assure regulatory compliance and technical feasibility of proposed changes.
• Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
• Responsible to maintain permanent inspection readiness and actively support regulatory inspections. Hands-on in computerized systems such as Comet, Learning management, Electronic Batch Record, and support implementation of any necessary updates.
• Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization.

Preferred Qualifications

• Cell/Gene Therapy cGMP manufacturing experience preferred.
• Experience in Aseptic Manufacturing or CAR-T manufacturing operations is a plus.