Associate Director, Manufacturing

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

Who We Are

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

Who We Are

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

The Associate Director of Manufacturing is responsible for leadership and oversight of cell therapy manufacturing.

How You Will Make an Impact

• 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.

Compliance/Training/Deviations

• 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.

Quality & Regulatory Partnership

• 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.

Continuous Improvement

• 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.

Leadership

• RoslinCT leaders motivate, inspire, build, and retain highly effective manufacturing team while managing for high performance and developing others. They are versatile learners and courageous decision makers.
• 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.
• Acting 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.

What You Will Bring

• 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.

Qualifications

• 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.

Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.

At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career.

Benefits include:

• medical, dental, and vision insurance
• educational assistance
• a 401(k) program
• a variety of additional resources to help you thrive both personally and professionally

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.