Director of Manufacturing

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 Director of Manufacturing (Cell Therapy) provides leadership and guidance across the Manufacturing Operations Teams and to direct GMP readiness activities. This role is responsible for providing operational and technical oversight to the team, as well as working with a multidisciplinary group within the organization to ensure the seamless execution of manufacturing operations. The incumbent is experienced in cell and gene therapy (allogeneic) processes and cGMP operations, and is comfortable working in a fast-paced, entrepreneurial environment with broad responsibilities and opportunities. The Director collaborates effectively with cross-functional teams including Process Development, Engineering, Facilities, Supply Chain, Quality Control, Quality Assurance and Validation to accomplish deliverables for GMP readiness.

Job Requirements

• Develop and improve internal manufacturing operations strategy and procedures in collaboration with all departments.
• Produce GMP material on time, according to the manufacturing timelines and demand plan.
• Develop strategic plans for cell and gene therapy manufacturing, including resource allocation, budgeting, and performance metrics.
• Establish a program for cross-functional planning meetings and maintain/manage the manufacturing schedule in collaboration with support groups through the planning meetings to ensure operational coordination.
• Ensure trained manpower resources are adequate to complete operations in a cGMP compliant manner. Ensure compliance with all applicable GMP regulations and SOPs.
• Lead investigations related to the manufacturing process. Author deviations, nonconformances, CAPAs and change controls, as required. Partner with Quality to address issues effectively and compliantly.
• Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
• Manage on-time establishment of process batch records and equipment processes to ensure GMP operational readiness and performance.

Education & Experience

• Bachelor’s or Master’s in a related field.
• 7 years in cell and gene therapy manufacturing and leadership

Knowledge, Skills & Abilities

• Strong quality and compliance background in a cGMP biopharmaceutical operations (Manufacturing and Quality) environment; sound working knowledge of health authority regulations.
• Strong technical background in cell and genetic therapy related manufacturing operations, ideally allogeneic cell therapy and adherent cell line experience.
• Solid experience in equipment and facility qualification and validation.
• Strong technical background in aseptic manufacturing operations.
• Solid project management skills and experience managing complex projects.
• Strong verbal and written communication skills: ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Proven leadership skills with a focus on team development, innovation, and continuous learning.
• Ability to work calmly and make sound decisions in a fast-paced environment where priorities can change quickly.
• Ability to provide hands-on support to floor operations as needed.

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 : $175,000 - $200,000