Director/Senior Director of Manufacturing

Company Overview: Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients. Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits. Today, Strand has established three platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts with an additional site based in Watertown, Massachusetts. Job Summary: Strand is looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work in a matrix-based environment and be a part of the future strategy of the company. We are looking for a highly motivated and enthusiastic leader for the role of Director/Senior Director of Manufacturing. Reporting to the Vice President of Technical Operations, the Director/Senior Director will be responsible for leading all manufacturing activities including but not limited to oversight of process scale up through clinical supply. This individual will be a strategic thinker that brings a leadership presence and enthusiasm for Strand along with a desire to conquer new challenges. Primary Responsibilities: Serve as the primary lead for all tech transfer activities including collaboration with the technical lead of the tech transfer. Provide leadership oversight and management of third party vendors such as CMOs and ensure deliverables are timely and compliant with FDA and cGMP regulations. Serve as the operational lead to optimize all GMP production-related activities and technical processes across the company. Manage all CMC documentation and deliverables essential for regulatory interactions, application filings, briefing books etc. Collaborate closely with internal leadership within Quality, Regulatory Sciences, Analytical Development and Process Development as well as the Executive Leadership Team. Oversee and manage supply chain operations. Support ongoing initiatives to identify next generation manufacturing strategies along with the Vice President of Technical Operations. Qualifications: B.S. with 10-12+ years or an advanced degree with 7-8+ years of working experience in CMC in biotech; Experience working in a startup or smaller company setting highly preferred. Extensive experience in external manufacturing required. Experience working in gene and/or cell therapies required. In depth understanding of FDA guidelines and GMP/ICH regulations. Technical writing experience writing CMC sections for regulatory filings required. Prior experience interacting and supporting functions including but not limited to process development, and regulatory aspects of mRNA LNP products. Expertise with fill/finish and label pack activities for biologics required. Prior working experience leading a team or managing multiple direct reports. Ability to quickly adapt to change and thrive in a dynamic and entrepreneurial early-stage environment. A strong team player with excellent oral and written communication skills and a demonstrated ability to work independently. Strand offers a fast-paced, entrepreneurial, team-focused work environment. We also offer a top-notch benefits package (health, dental, life, vacation, 401k, and commuter) and work/life integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet the company goals. Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates. Job Type: Full-time Salary: Commensurate with role and experience #J-18808-Ljbffr

Created: 2024-11-05