Manufacturing Specialist

BioSpace; Northbridge (MA); On-site; USD 4,968,000 - 6,480,000; Full time

Job summary

EyePoint Pharmaceuticals is seeking a Senior Manufacturing Associate to lead and execute complex manufacturing, assembly, packaging, labeling, and inspection for combination products in a GMP environment. You will serve as SME, train staff, and drive process improvements while ensuring compliance and product quality.

This role requires 5+ years in regulated manufacturing and a strong background in device/biopharma production, with a focus on documentation, problem-solving, and cross-functional

Qualifications

• 5+ years in regulated manufacturing environment.
• Experience in medical device, pharmaceutical, biotechnology, or combination product manufacturing.
• Experience supporting investigations, process improvements, equipment troubleshooting, and training.
• Prior experience as lead operator, trainer, or SME preferred.

Responsibilities

• Independently perform complex manufacturing, assembly, packaging, labeling, and inspection operations.
• Serve as a subject matter expert (SME) for assigned manufacturing processes, equipment, and production activities.
• Set up, operate, troubleshoot, and perform advanced process adjustments on manufacturing equipment.
• Review batch records, device history records, logbooks, and production documentation for accuracy and completeness.
• Identify, investigate, and resolve manufacturing issues while ensuring compliance with procedures and quality requirements.
• Lead or support deviation investigations, nonconformance investigations, root cause analyses, CAPAs, and other quality activities.
• Support process validation, equipment qualification, engineering studies, and technology transfer.
• Develop, revise, and improve manufacturing procedures, work instructions, forms, and training materials.
• Train, mentor, and qualify manufacturing personnel while supporting onboarding and development programs.
• Partner with Quality, Engineering, Supply Chain, and Regulatory teams to support objectives and compliance initiatives.
• Drive continuous improvement initiatives focused on productivity, quality, cost reduction, safety, and efficiency.
• Monitor manufacturing metrics and recommend process improvements based on data analysis.
• Assist leadership in capacity planning, production readiness, and scheduling support.
• Maintain production areas in a state of inspection readiness.
• Promote a culture of safety, quality, accountability, and continuous improvement.

Skills

cGMP knowledge

GDP basics

Quality systems

Manufacturing expertise

Root cause analysis

Training & mentoring

Equipment troubleshooting

Documentation practices

Education

High School Diploma or GED

Associate's or Bachelor's degree in Engineering/Life Sciences/Manufacturing

Tools

Electronic Quality Management System

Job description

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 Senior Manufacturing Associate is an advanced manufacturing professional responsible for leading and executing complex manufacturing, assembly, packaging, inspection, and production support activities for combination products in a GMP-regulated environment. This role serves as a subject matter expert (SME) for manufacturing processes, equipment, and documentation practices while providing technical leadership, training, and operational support to the manufacturing team. The Senior Manufacturing Associate drives operational excellence through process improvements, troubleshooting, investigation support, and cross-functional collaboration to ensure the consistent production of safe, effective, and high-quality products.

Responsibilities

• Independently perform complex manufacturing, assembly, packaging, labeling, and inspection operations.
• Serve as a subject matter expert (SME) for assigned manufacturing processes, equipment, and production activities.
• Set up, operate, troubleshoot, and perform advanced process adjustments on manufacturing equipment.
• Review batch records, device history records, logbooks, and production documentation for accuracy and completeness.
• Identify, investigate, and resolve manufacturing issues while ensuring compliance with approved procedures and quality requirements.
• Lead or support deviation investigations, nonconformance investigations, root cause analyses, CAPAs, and other quality system activities.
• Support process validation, equipment qualification, engineering studies, and technology transfer activities.
• Develop, revise, and improve manufacturing procedures, work instructions, forms, and training materials.
• Train, mentor, and qualify manufacturing personnel while supporting onboarding and development programs.
• Partner with Quality, Engineering, Supply Chain, and Regulatory teams to support manufacturing objectives and compliance initiatives.
• Drive continuous improvement initiatives focused on productivity, quality, cost reduction, safety, and operational efficiency.
• Monitor manufacturing metrics and recommend process improvements based on performance trends and data analysis.
• Assist leadership in capacity planning, production readiness activities, and scheduling support.
• Maintain production areas in a state of inspection readiness.
• Promote a culture of safety, quality, accountability, and continuous improvement.

Required Skills/Knowledge

• Advanced knowledge of cGMP regulations, Good Documentation Practices (GDP), and quality system requirements.
• Strong understanding of combination product manufacturing and regulated production environments.
• Expertise in manufacturing documentation, batch record execution, and production processes.
• Advanced troubleshooting and problem-solving skills.
• Ability to lead investigations and identify root causes of manufacturing and quality issues.
• Strong technical aptitude with manufacturing equipment and automated systems.
• Experience with electronic quality management systems preferred.
• Excellent organizational, communication, and interpersonal skills.
• Ability to train, mentor, and develop manufacturing personnel.
• Demonstrated ability to lead projects and drive process improvements.
• Ability to work independently and exercise sound judgment in a dynamic manufacturing environment.
• Ability to lift up to 25lbs.
• Ability to wear personal protective equipment (PPE), including cleanroom gowning.
• Ability to stand, walk, bend, reach, and perform repetitive motions for extended periods.
• This position requires an eye exam.

Experience

• 5+ years of experience in a regulated manufacturing environment.
• Significant experience in medical device, pharmaceutical, biotechnology, or combination product manufacturing required.
• Demonstrated experience supporting investigations, process improvements, equipment troubleshooting, and training activities.
• Prior experience serving as a lead operator, trainer, or subject matter expert preferred.

Education

• High School Diploma or GED required.
• Associate's or Bachelor's degree in Engineering, Life Sciences, Manufacturing, or a related technical discipline 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

$36.06 - $47.04 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.