QC Scientist

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.

The QC Scientist Technical Services (QCTS) is responsible for the planning, coordination, and technical oversight of Neurotech’s QCTS group. This role will lead the scheduling and execution of activities supporting both Quality Control Analytical operations and cross-functional initiatives with Commercialization Sciences. The incumbent will ensure the consistent availability, integrity, and traceability of all reference standards, assay controls, reagents, and other critical testing materials.

This role combines technical leadership and hands-on scientific support to enable method development, method transfer, and continuous improvement initiatives across the QC and R&D interface.

Job Requirements

• Oversee daily scheduling, prioritization, and execution of QCTS activities supporting QC Analytical operations.
• Lead the creation, qualification, and maintenance of reference standards, assay controls, and test reagents in compliance with GMP requirements.
• Ensure appropriate documentation, lifecycle management, and traceability of all QCTS materials.
• Collaborate closely with the QC Analytical, Commercial Sciences, and Process Development teams to support method development, method optimization, and transfer activities.
• Support new product development and characterization testing through technical expertise and resource management.
• Author, review, and approve technical documents including SOPs, protocols, reports, and investigations.
• Serve as a subject matter expert (SME) for analytical reagents, control systems, and reference material management.
• Train and mentor QCTS staff to ensure consistent performance, technical competency, and adherence to cGMP and GDP practices.
• Partner with Quality Assurance to ensure inspection readiness and continuous improvement of laboratory systems.
• Drive operational excellence by identifying and implementing process improvements in material management, documentation, and testing workflows.
  
  

Education & Experience

• Bachelor’s or Master’s degree in Biology, Biochemistry, Biotechnology, or related scientific discipline.
• 6–10 years of progressive laboratory experience within Quality Control or Analytical Development, preferably in a biologics, cell therapy, or gene therapy environment.
• Demonstrated expertise in bioassay execution, analytical reagent management, and method lifecycle support.
• Proven leadership experience, with the ability to coordinate multidisciplinary teams and projects.
• Strong understanding of GMP, GLP, and data integrity requirements.
• Excellent technical writing, organizational, and communication skills.
• Experience with method development, transfer, and validation activities highly desirable.
• Prior supervisory or team lead experience preferred.
  
  

Knowledge, Skills & Abilities

• Technical and Analytical Rigor
• Leadership and Team Development
• Problem Solving and Decision Making
• Cross-functional Collaboration
• cGMP Compliance and Documentation Excellence