Manufacturing Associate II

Initial Therapeutics, Inc.; Watertown (MA); On-site; USD 44,372 - 57,528; Full time

Job summary

EyePoint is seeking a Manufacturing Associate II to execute manufacturing, assembly, labeling, packaging, and inspection for combination products in a GMP-regulated environment. This role requires proficiency in manufacturing operations, GMP documentation, and equipment operation, serving as a trained operator who can work with minimal supervision.

Based in Watertown, MA, the position supports process improvements, training of junior associates, and adherence to quality and compliance objectives

Qualifications

• 2–5 years of experience in a regulated manufacturing environment.
• Experience in medical device, pharmaceutical, biotechnology, or combination product manufacturing.
• GMP documentation and equipment operation experience.

Responsibilities

• Perform manufacturing, assembly, labeling, packaging, and inspection per approved procedures and schedules.
• Operate and troubleshoot manufacturing equipment with minimal supervision.
• Complete batch records and production documentation accurately and contemporaneously.
• Set up line changes, perform product changeovers, and assist with material handling and reconciliation.
• Identify deviations, assist with CAPAs, and support deviation investigations.

Skills

GMP compliance

GDP documentation

Batch records

Equipment operation

Quality awareness

Training junior staff

Problem solving

Communication

Safety & PPE

Education

High School Diploma or GED

Associate degree or technical certification (preferred)

Job description

Manufacturing & Operations at EyePoint ensures the safe, compliant, andreliable production of innovative therapies for patients with serious retinal diseases. This teamoversees end-to-end manufacturing, supply chain, and facilities with a strong focus onregulatory compliance, patient safety, and product integrity. Manufacturing & Operations strivesto maintain rigorous standards and efficient processes with the goal of delivering safe, high-quality therapies to patients.

The Manufacturing Associate II is responsible for executing manufacturing, assembly, packaging, inspection, and related production activities for combination products in a GMP-regulated environment. This role requires demonstrated proficiency in manufacturing operations, GMP documentation, and equipment operation. The Manufacturing Associate II serves as a fully trained operator who can work with minimal supervision, support process improvements, assist with training of junior associates, and contribute to achieving production, quality, and compliance objectives.

Responsibilities:

• Perform manufacturing, assembly, labeling, packaging, and inspection, activities in accordance with approved procedures and production schedules.
• Independently execute manufacturing operations while ensuring compliance with GMP, GDP, and company standards.
• Complete batch records, logbooks, and other production documentation accurately and contemporaneously.
• Set up, operate, troubleshoot, and perform basic maintenance on manufacturing equipment.
• Conduct in-process inspections and verify product quality throughout manufacturing operations.
• Perform line clearances, room preparation, product changeovers, and equipment setup activities.
• Assist with material handling activities, including staging, issuing, and reconciliation of in-process materials and finished goods.
• Identify and elevate process deviations, equipment issues, quality concerns, and safety risks.
• Support deviation investigations, nonconformance activities, corrective and preventive actions (CAPAs), and root cause analyses.
• Participate in process validation, equipment qualification, and manufacturing engineering activities as required.
• Train and mentor junior personnel on procedures, equipment operation, documentation practices, and GMP expectations.
• Support continuous improvement initiatives focused on quality, efficiency, productivity, and compliance.
• Collaborate effectively with Quality Assurance, Quality Control, Engineering, Supply Chain, and other functional teams.
• Maintain production areas and equipment in a state of inspection readiness.
• Comply with all company safety policies, GMP regulations, and training requirements.

Required Skills/Knowledge:

• Working knowledge of cGMP regulations, Good Documentation Practices (GDP), and quality system requirements.
• Proficiency in manufacturing documentation and batch record execution.
• Ability to operate and troubleshoot manufacturing and packaging equipment.
• Strong attention to detail and commitment to product quality.
• Ability to identify process issues and recommend practical solutions.
• Effective organizational and problem-solving skills.
• Strong verbal and written communication skills.
• Basic proficiency with electronic quality management systems preferred.
• Ability to train others and effectively transfer knowledge.
• Demonstrated ability to work independently with limited supervision.
• 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:

• 2–5 years of experience in a regulated manufacturing environment.
• Experience in medical device, pharmaceutical, biotechnology, or combination product manufacturing required.
• Experience operating production equipment and documenting manufacturing activities in a GMP environment preferred.

Education:

• High School Diploma or GED required.
• Associate degree, technical certification, or coursework in manufacturing, engineering, life sciences, or a related discipline preferred.

EyePoint is committed to fair andequitablecompensation practices.The salaryoffer iscommensuratewithEyePoint’scompensation philosophy and considers factors including but notlimited 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

$32.21 - $41.76 USD

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed topreventing blindnessby 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.