Manufacturing Associate II/III

Neurotech Pharmaceuticals, Inc. is a private biotech 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, our focus has been on developing and commercializing transformative therapies for chronic eye diseases. The core platform technology, Encapsulated Cell Therapy (ECT), is a first-in-class drug delivery platform designed to slow the progression of chronic eye diseases. Neurotech's first commercial product, ENCELTO TM (revakinagene taroretcel-lwey), is approved in the United States for the treatment of adults with idiopathic Macular Telangiectasia Type 2 (MacTel). Encapsulated cell-based gene therapy is designed to provide long-term, sustained delivery of therapeutic proteins for the treatment of chronic eye diseases.

We are currently seeking to add a
Manufacturing Associate
who will play a vital role in day-to-day, hands-on cGMP manufacturing operations. The Manufacturing Associate will be an independent thinker to monitor and troubleshoot critical processes and regularly draft and revise documents such as Batch Records and SOPs. S/he will also provide peer review of 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.

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.
• Lead project(s) from creation of tasks through execution and closure.
• Create batch records and SOPs for newly defined processes
• Assist with manufacturing material management.
• Assist with and Own quality systems.
• May be required to prepare, sanitize, and disinfect equipment to prevent microbial contamination

Education And Experience

• Bachelor's degree in Science with a minimum of 2 years' experience with aseptic upstream biologic production or aseptic fill/finish processes in a GMP environment or
• High School Diploma/Associate's with a minimum of 4 years' experience with aseptic upstream biologic production or aseptic fill/finish processes in a GMP environment.

Knowledge, Skills, And 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 organization and planning skills
• Must be proficient in Microsoft Office (Word, Outlook, Excel, Powerpoint)
• Ability to demonstrate technical writing capability
• Experience with and Basic troubleshooting skills on Manufacturing and lab equipment
• Support Quality and Validation activities/documentation as needed
• 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 project team
• Experience with manufacturing automated systems and electronic batch reporting a plus.

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.