Analytical Testing Quality Control Laboratory Manager

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. 

The Analytical Testing QC Lab Manager leads and oversees all operations within our commercial pharmaceutical analytical testing laboratory to ensure product quality and regulatory compliance. This role emphasizes building and guiding a high-performing lab team, implementing robust testing protocols, and fostering an environment of continuous improvement. The ideal candidate is an inspirational leader who sets clear goals, empowers team members, and delivers results per schedule.  

Job Requirements

• Plan, organize, and prioritize lab activities to meet production deadlines and quality goals.
• Work closely with Development, Production, Supply Chain, and other departments to address product issues, provide data insights, and drive overall quality improvements.
• Providing oversight and approval to department specific quality records including CAPAs and Change Controls
• Regularly share data, insights, and progress updates across the organization, fostering transparency and preventing siloed decision-making.
• Coordinates and facilitates laboratory activities to meet batch release commitments on-time
• Ensures assay readiness with adequate inventory of qualified reagents and trained analysts.
• Maintains QC lab in audit ready state with an eye on continuous improvement.
• Leads coordination and review of method transfers and equipment qualification/requalification
• Authors, review, and/or approves data, SOPs, COAs, analytical methods, protocols and reports
• Monitor, track and own lab metrics.
• Will be required to lead OOS/OOT investigations/deviations and to identify corrective actions to prevent re-occurrence.   

Education & Experience

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Microbiology, or a related scientific field.
• 5-7 years of experience in an analytical testing laboratory, including at least 2 years in a leadership or managerial role.
• Proven ability to manage high-performing teams, continually provide hands on mentorship, and foster a collaborative environment.
• Strong command of analytical testing methodologies, instrumentation (e.g., bioassay, cell cuture, Elisa, Western Blot, etc.), and relevant FDA and cGMP standards.
• Adept at identifying process improvements, troubleshooting complex issues, and driving data-based decisions.
• Excellent verbal and written communication skills; able to engage stakeholders at all levels.
• Skilled at managing multiple projects, meeting deadlines, and adapting to changing priorities.

Knowledge, Skills & Abilities

• The ability to adapt to working effectively within a variety of situations.
• Adapts to rapid organizational growth 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.
• Embedding discipline and thoroughness in our approaches.
• 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.