Manufacturing Associate Job at NEUROTECH U S A in Cumberland

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI and Needham, MA, within the realm of Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary drug delivery platform for treatment of a variety of retinal disorders. Our drug delivery platform - Encapsulated Cell Technology (ECT) - is designed to deliver genetically modified therapeutics to slow the progression of chronic retinal diseases. Our most advanced program is delivering a neurotrophic factor to treat the orphan disease Macular Telangiectasia Type 2 (MacTel).

The Manufacturing Associate plays a vital role in day-to-day manufacturing operations, while also preparing for Neurotech’s commercial launch. The incumbent will be an independent thinker to monitor and troubleshoot critical processes and regularly draft and revise documents such as Batch Records, SOPs, and technical reports, such as Deviations, CAPAs and Change Controls. In addition, the Manufacturing Associate will identify, recommend, and implement improvements related to routine floor operations.

This is an onsite role in Cumberland, RI. This is not a hybrid or remote opportunity.

Please note, this role is not eligible for agency recruiting support. Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.

Job Requirements

• Perform basic to complex aseptic operations within an ISO 5 environment according to Batch Records and SOPs.
• Document all activities in Batch Records, Logbooks, Forms, etc. using Good Documentation Practices.
• Follow verbal and written procedures in operating production equipment and to monitor/perform process steps while being able to identify subtle variances or escalating events that are non-routine in nature.
• Perform in-process testing and other tasks as assigned that ensure sustainable right-first-time performance.
• May be required to prepare, sanitize, and disinfect equipment to prevent microbial contamination.
• Assist with Manufacturing materials management.
• Support Quality and Validation activities as needed.

Education & Experience

• BS in biology, biotechnology, or related field with a minimum of 3 years’ experience with aseptic upstream biologic production or aseptic fill/finish processes in a cGMP environment, or
• High School Diploma/Associate’s with a minimum of 6 years’ experience with aseptic upstream biologic production or aseptic fill/finish processes in a cGMP environment.
• Experience with automated manufacturing systems and electronic batch reporting is a plus.

Knowledge, Skills & Abilities

• Must have cGMP manufacturing experience with the ability to interpret and apply GMP knowledge.
• Must have Cell Culture experience and technical understanding of adherent cell culture processes.
• Must be detail-oriented with strong organization and planning skills.
• Must be proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint)
• Ability to demonstrate technical writing capability.
• Experience with and basic troubleshooting skill on manufacturing and lab equipment.
• Must possess a positive attitude and willingness to perform hands-on daily operations.
• Must be able to work independently day-to-day and collaboratively on a project team.

Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.