Director of Quality Control

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 multiple programmable mRNA 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.

Become the next standout single strand!

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 innovative candidate for the role of Director of Quality Control. Reporting to the Vice President of Quality, this individual will lead the design, implementation, and oversight of QC processes to support programs from early-stage research through all aspects of development into commercial readiness. The individual will collaborate closely with Quality Assurance, Technical Operations and R&D to ensure compliance of DS/DP with FDA and other global regulatory standards.

Primary Responsibilities:

• Serve as Head of Quality Control and build an internal QC function under the direction of the Vice President of Quality, including resource planning, development of processes and procedures, oversight of all QC-related data, evaluation of computerized system needs and timing related to the development lifecycle.
• Provide QC leadership and ownership for GMP Stability, Specifications, batch data review, COA generation, OOS investigation, and Reference Standards.
• Ensure QC readiness for internal and external audits as well as inspections, prepare required documentation, and champion data integrity across systems.
• Partner with External Contract Labs and Strand Technical Operations (including analytical development, manufacturing and clinical supply chain) to optimize release workflows and minimize deviations.
• Provide leadership to drive late phase analytical method validation strategies.
• Manage QC budgetary needs including but not limited to external resources such as consultants, vendor relationships etc.
• Partner with Quality Assurance Operations and Quality Systems as the QC subject matter expert to ensure cohesiveness amongst systems and workflows.
• Collaborate with Regulatory Sciences to complement the regulatory strategies for all program needs.

Qualifications:

• B.S. or advanced degree in Life Sciences, Chemistry, Biology or similar field.
• 10-15+ years of QC experience working in biotech, pharma or a similar space required.
• Extensive QC experience within the gene/cell therapies space and experience with mRNA LNP therapies is required.
• Exceptional project management skills and proven track record of generating deliverables in a timely manner.
• Experience with FDA, GMP and regulatory standards required.
• Knowledge and/or experience in leveraging AI to build efficiencies into QC processes.
• Experience with health authority inspections is required.
• Prior experience building an internal QC function and infrastructure preferred.
• 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 small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and 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 Strand’s 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