Associate Director, Manufacturing Operations

Manufacturing & Operations at EyePoint ensures the safe, compliant, and reliable production of innovative therapies for patients with serious retinal diseases. This team oversees end-to-end manufacturing, supply chain, and facilities with a strong focus on regulatory compliance, patient safety, and product integrity. Manufacturing & Operations strives to maintain rigorous standards and efficient processes with the goal of delivering safe, high-quality therapies to patients. The Associate Director, Manufacturing is responsible for the leadership, strategic planning, and operational execution of manufacturing activities supporting the production of GMP-regulated combination products. This role supports manufacturing personnel, production scheduling, resource planning, process performance, and compliance activities to ensure the safe, efficient, and compliant manufacture of commercial and clinical products. The Associate Director serves as a key member of the Operations leadership team and partners closely with Quality, Engineering, Supply Chain, Regulatory, and Product Development functions to drive operational excellence, maintain inspection readiness, and support company growth objectives. This position will report to Sr. Director, Manufacturing & Technical Operations and will be onsite at our Northbridge, MA facility. Primary responsibilities include, but are not limited to, the following: Individual Responsibilities Lead all day-to-day manufacturing operations to ensure product quality, compliance, on-time delivery, and operational efficiency. Develop and execute manufacturing strategies aligned with company objectives, production forecasts, and business goals. Manage and develop a team of managers, senior manufacturing associates, and manufacturing personnel across multiple shifts. Establish departmental goals, objectives, staffing plans, and performance metrics. Drive a culture of quality, safety, accountability, and continuous improvement throughout Manufacturing Operations. Ensure manufacturing activities are conducted in accordance with cGMP requirements, approved procedures, quality systems, and regulatory expectations. Partner with Supply Chain and Planning functions to ensure production schedules, material availability, and capacity requirements are achieved. Monitor manufacturing performance metrics and implement improvements to increase throughput, efficiency, quality, and cost effectiveness. Oversee manufacturing investigations, deviations, nonconformances, and CAPA activities to ensure timely and effective resolution. Provide leadership and support for regulatory inspections, customer audits, and internal audits. Collaborate with Quality Assurance to maintain inspection readiness and support ongoing compliance initiatives. Lead manufacturing readiness activities for new product introductions, process transfers, scale-up efforts, and commercialization projects. Support process validation, equipment qualification, facility expansion, and technology transfer initiatives. Develop and manage departmental budgets, capital expenditures, and operating expenses. Partner with Engineering functions to identify and implement equipment, automation, and process improvements. Assess manufacturing capacity and develop workforce and infrastructure strategies to support business growth. Review and approve manufacturing procedures, training programs, and production documentation as appropriate. Establish succession planning and talent development strategies for manufacturing personnel. Provide leadership for cross-functional initiatives and operational excellence programs. Ensure compliance with company safety programs, environmental requirements, and workplace health standards. Primary skills and knowledge required include, but are not limited to the following: Advanced knowledge of cGMP regulations, FDA requirements, and quality system principles. Strong understanding of combination product manufacturing operations. Demonstrated expertise in manufacturing planning, scheduling, and capacity management. Proven leadership and people management skills. Strong understanding of lean manufacturing, continuous improvement, and operational excellence methodologies. Experience leading investigations, CAPAs, and quality system activities. Knowledge of manufacturing validation, equipment qualification, and technology transfer processes. Budget management experience. Excellent organizational, analytical, and decision-making skills. Ability to effectively influence cross-functional teams and stakeholders. Outstanding written and verbal communication skills. Proficiency with electronic quality systems and manufacturing reporting tools. Level of Education Required: Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Operations Management, or a related technical discipline required. Advanced degree (MBA, MS, or similar) preferred. Number of Years of Experience in the Function and in the Industry: 8–12 years of experience in GMP-regulated manufacturing environments. Minimum of 3–5 years of progressive manufacturing leadership experience. Experience in combination products, medical devices, pharmaceuticals, biotechnology, or other regulated industries required. Demonstrated experience leading manufacturing teams through commercial production, scale-up activities, inspections, and operational improvements. Experience supporting regulatory inspections and quality system compliance activities preferred. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below: Salary Range

$150,000 - $190,207 USD

Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. #J-18808-Ljbffr Initial Therapeutics, Inc.