Associate Director, Manufacturing

RoslinCT US•Hopkinton, MA

11d•$140,000 - $200,000

About The Position

The Associate Director of Manufacturing is responsible for leadership and oversight of cell therapy manufacturing. This role involves ensuring the safety of manufacturing areas and work practices, leading and developing a high-performing team, providing leadership and direction in alignment with cGMP requirements, and partnering with Scheduling and Supply Chain to support production schedules. The position also involves establishing and monitoring key performance indicators, overseeing staff training and qualifications, ensuring manufacturing instructions and batch records are up-to-date, and managing deviations, investigations, CAPAs, and Change Controls. A key aspect of the role is partnering with Quality Assurance for "right first time" execution, maintaining inspection readiness, reviewing and approving manufacturing documentation, and participating in regulatory inspections and client audits as a subject matter expert. Continuous improvement is also a focus, involving identifying and implementing opportunities to enhance manufacturing processes, efficiency, and compliance, troubleshooting operational issues, and leading departmental projects. RoslinCT leaders are expected to motivate, inspire, build, and retain effective teams, manage people processes, act as role models, and build a culture based on company values.

Requirements

Bachelor's degree in sciences or engineering discipline with a minimum of 10-15 years of industry experience or a master’s degree with a minimum of 8-10 years of industry experience.
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.
A highly organized work style that ensures timely execution of tasks.
A mindset that ensures accurate results.
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
Effective problem-solving capabilities.
Strong oral and written 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.
Ensure staff are appropriately trained and qualified to perform assigned responsibilities.
Oversee execution of the departmental training plan and ensure training materials are accurate and up to date.
Ensure manufacturing instructions and batch records reflect current practices and are aligned with cGMP and company standards.
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.
Motivate, inspire, build, and retain highly effective manufacturing team while managing for high performance and developing others.
Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire team to achieve goals in the immediate and longer term.
Manage and administer people processes including selection, hiring, promotion, and compensation and provide training of personnel on company and department policies systems and processes.
Act as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Build a culture based on company values.