What are the responsibilities and job description for the QC Raw Materials Supervisor position at NEUROTECH U S A?
Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI and Needham, MA, within 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) platform 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) For over two decades, we have pioneered the development of our proprietary Encapsulated Cell Therapy (ECT) platform, designed to address chronic retinal diseases. Our lead program focuses on Macular Telangiectasia Type 2 (MacTel), a rare retinal disorder, leveraging ECT's innovative approach to provide sustained, targeted treatment directly to the eye.
We’re looking for a highly driven and detail-oriented QC Raw Materials Supervisor with 6–8 years of pharmaceutical industry experience to take full ownership of the raw materials release process. This role is key in ensuring that all incoming raw materials meet FDA, EU Annex, and internal quality requirements before they’re released for production. This position will managing a small team of QC analysts, overseeing the day-to-day testing and review activities, and leading strategic initiatives to improve efficiency and compliance.
Job Requirements
- Supervise and mentor a small team of analysts responsible for raw material testing, data review, and documentation.
- Act as SME for Raw Material testing methods including physical and chemical testing methods including pH, FTIR, tensile strength, and Raman.
- Perform laboratory testing to support Raw Material release.
- Own the raw material release process end-to-end, including coordination with sampling, warehouse, purchasing, and manufacturing.
- Ensure raw material testing and documentation complies with FDA cGMPs, ICH guidelines, and EU Annex 1/13 requirements.
- Continue to develop, implement, and manage QC raw materials programs—tracking KPIs, initiating continuous improvements, and maintaining robust quality systems.
- Provide technical oversight for analytical testing and support troubleshooting and investigations.
- Review and approve laboratory documentation, deviations, change controls, and OOS investigations related to raw materials.
- Prepare and support internal and external audits by ensuring inspection readiness at all times.
- Work closely with Quality Assurance, Regulatory Affairs, Supply Chain, and Manufacturing teams.
Education & Experience
- Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or related field.
- 6–8 years of experience in Quality Control within a cGMP pharmaceutical environment.
- At least 2 years of leadership/supervisory experience preferred.
- Strong working knowledge of FDA, ICH, and EU Annex requirements related to raw materials.
- Experience with compendial testing methods (USP, EP, JP) and LIMS/empower systems.
- Proven ability to lead and develop high-performing teams.
- Excellent organizational and communication skills.
Knowledge, Skills & Abilities
- Experience with sterile manufacturing environments or biologics.
- Familiarity with SAP or other ERP systems.
- Proven track record in scheduling workflows, reviewing documentation, and managing assay-related operations.
- Strong attention to detail, organizational skills, and ability to handle multiple projects simultaneously.
- Excellent written and verbal communication skills to effectively share data and results.
- Familiarity with lab software and digital documentation systems a plus.
- Adapts to organizational change and to changes in job demands.
- Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.
- Pursues tasks with energy, drive, and initiative, even in the face of adversity; comfortable in a results-driven, highly accountable environment where you can make an impact.
- Strong ability to work collaboratively across departments.
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.
Salary : $80,000 - $100,000