Manufacturing Specialist

EyePoint Pharmaceuticals; Watertown (MA); On-site; USD 55,000 - 80,000; Full time

Job summary

A leading pharmaceuticals company in Massachusetts is seeking a Manufacturing Specialist to oversee production activities, maintain compliance with cGMP regulations, and ensure quality in a dynamic team environment. This role requires substantial experience in pharmaceutical manufacturing processes and strong communication skills, with a commitment to excellence and collaboration.

Benefits

Excellent Compensation Package

Comprehensive Benefits

Equity Options

Qualifications

• 5+ years of experience in a cGMP environment.
• Knowledge of cGMP regulations and FDA guidance.
• Experience with ISO7 cleanrooms and aseptic techniques.

Responsibilities

• Lead manufacturing activities in controlled ISO 7 cleanrooms.
• Maintain production documentation and quality records.
• Support manufacturing related deviations and investigations.

Skills

Communication

Collaboration

Problem-solving

Quality awareness

Education

High School Diploma or equivalent

Job description

Overview

Be Seen and Heard at EyePoint

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

We See You.

• Your wellbeing
• Your professional worth
• Your future at EyePoint

EyePoint offers robust total rewards in ascience-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career.There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

The Manufacturing Specialist will work with the production teams to manufacture product and ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. As a subject matter expert for product and process knowledge, the specialist role will be the on the floor lead for product and process related issues. This position requires experience with cGMP manufacturing. Excellent hand/eye coordination required for the handling & related process operations required for manufacture of small ophthalmic inserts. The Manufacturing Specialist role will report directly to the Manufacturing Supervisor and will be located at our Watertown, MA site.

Excellent Compensation Package, including Equity and Comprehensive Benefits upon hire.

Responsibilities

Primary responsibilities include, but are not limited to, the following:

Individual responsibilities

• Perform and lead manufacturing activities in controlled classified ISO 7 cleanrooms adhering to current good manufacturing practices (GMP’s), governmental guidelines and company procedures.
• Maintain on the floor production documentation and quality records including Master Batch Records, applicable SOPs, training materials and other documentation.
• Partner with manufacturing management to schedule and plan manufacturing activities in a team environment.
• Facilitate a “speak up” culture to ensure all cGMP compliance activities are followed.
• Ensure processes remain inspection ready at all times.
• Support manufacturing related Deviations, Temporary Change Requests and Investigations per applicable SOP’s.
• Support process efficiency and production optimization efforts.
• Ensure that work environment is maintained clean, safe and organized.
• Monitor and maintain the accuracy and movement of raw materials used in manufacturing utilizing ERP system (NetSuite).
• Initiation and closure of work orders, material requests and transfer orders.
• Monitor, maintain and assist with daily cleaning activities and logs for manufacturing areas and equipment.
• Guide and train other manufacturing associates on procedures and processes when needed.
• Work with all departments at EyePoint.
• Other tasks as assigned.

Qualifications

Primary skills and knowledge required include, but are not limited to the following:

• Experience with production of pharmaceutical products in an ISO7 cleanroom environment including knowledge of gowning practices, cleanroom behaviors and aseptic techniques.
• Knowledge of cGMP regulations and FDA guidance applicable to drug product manufacturing.

• Previous experience working with medical device packaging and microscope assembly work.

• Strong communication skills, collaborative teammate, motivated and passionate about finding solutions.

• Strong awareness of quality issues. Compliance investigation experience preferred.

• Previous experience using semi-automated systems would be a plus.
• Ability to lift or carry up to 35 pounds.

Level of Education Required:

• High School Diploma or equivalent.

Number of Years of Experience in the Function and in the Industry:

• 5+ years of experience working in a cGMP environment in the pharmaceutical/biopharmaceutical or medical device industry.

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology companycommitted 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.

EyePointis proud to bean 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.

#LI-Onsite