Cell Therapy Manufacturing Associate Director

RoslinCT; Hopkinton (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Educational assistance

401(k) program

Professional development resources

Job summary

RoslinCT is seeking an Associate Director of Manufacturing to lead cell therapy production, ensure cGMP compliance, and build a high-performing team. You will partner with scheduling, quality, and supply chain to optimize production and drive continuous improvement across the manufacturing organization.

The role emphasizes leadership, project management, and delivering compliant manufacturing operations in a fast-paced, high-growth environment within RoslinCT.

Qualifications

• Bachelor's degree in sciences or engineering with 10–15 years of industry experience, or a master's degree with 8–10 years.
• 8–10 years in managing direct reports or project teams.
• 5 years of direct experience in cell therapy GMP manufacturing facilities.
• Experience in GMP documentation and compliance.
• Ability to operate and thrive in a fast-paced, high-growth environment.
• Strong skills in change management.
• Excellent communication skills.

Responsibilities

• Ensure safety of manufacturing areas and work practices in alignment with site Health, Safety, and Environmental programs.
• Lead and develop a high-performing team to execute departmental objectives; ensure effective resource utilization through performance management and employee development.
• Provide leadership and direction to staff in alignment with cGMP requirements, and department goals.
• Partner with Scheduling and Supply Chain to support development and execution of production schedules and drive adherence within the functional area.
• Establish and monitor key performance indicators aligned with departmental goals; track and communicate performance metrics.
• Oversee staff training and qualifications to perform assigned responsibilities.
• Oversee timely completion of deviations, investigations, CAPAs, and Change Controls within the department.
• Utilize quality and operational metrics to monitor performance and identify improvement opportunities.
• Partner with Quality Assurance to support “right first time” execution and real-time process review.
• Maintain inspection readiness within assigned manufacturing areas.
• Review and approve manufacturing documentation and support implementation of process or documentation changes.
• Participate in regulatory inspections and client audits as a manufacturing subject matter expert.
• Identify and implement opportunities to improve manufacturing processes, efficiency, and compliance.
• Partner with cross-functional teams to troubleshoot operational issues and support timely resolution.
• Lead departmental projects and contribute to cross-functional initiatives, ensuring appropriate controls and follow-through.
• RoslinCT leaders motivate, inspire, build, and retain highly effective manufacturing team while managing for high performance and developing others.

Skills

Organized work style

Attention to accuracy

Microsoft Office proficiency

Problem-solving

Communication skills

Education

Bachelor's degree in sciences or engineering

Master’s degree in sciences or engineering

Job description

RoslinCT is seeking an Associate Director of Manufacturing to lead cell therapy production, ensure cGMP compliance, and build a high-performing team. You will partner with scheduling, quality, and supply chain to optimize production and drive continuous improvement across the manufacturing organization.

The role emphasizes leadership, project management, and delivering compliant manufacturing operations in a fast-paced, high-growth environment within RoslinCT.