Manager/Senior Manager, MSAT

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 to build a team that understands the value of working at a start-up.  Joining Strand now places you alongside the founding executive team and world-leading advisors. We are 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 closely with the founding team and be a part of the growth strategy of the company.

We are seeking a highly innovative and self-motivated candidate for the role of Manager/Senior Manager of MSAT in our growing Technical Operations department. The ideal candidate will have experience in late-stage process validation and manufacturing, spanning from technology transfer through to commercial launch. Reporting to the Director of Manufacturing, the successful candidate will be a strategic thinker who brings relevant experience, strong leadership presence, and enthusiasm for Strand's mission. They will also possess deep knowledge of biologics manufacturing operations and cGMP documentation, playing a pivotal role within the Technical Operations team.

Primary Responsibilities:

• Serve as a CMC documentation expert for technical reports and regulatory filings (e.g., INDs, CTAs, BLAs, PIPs), and oversee the overall documentation plan.
• Act as the primary point of contact for CDMOs, including facilitation of Joint Manufacturing Steering Committees with key strategic vendors.
• Perform as person-in-plant (PIP) to facilitate a smooth tech transfer and provide on-site support.
• Manage long-term strategic supplier relationships and be accountable for supplier relationship management with each CDMO.
• Drive external execution of the manufacturing plan at CDMOs—from purchase order through material delivery—with a comprehensive understanding of the supply chain.
• Collaborate with the Clinical Supply Chain team to ensure a thorough and cohesive understanding of logistics and supply chain processes.
• Lead technology transfers to external CDMOs by performing risk assessments, generating/reviewing development reports, reviewing master batch records, and providing necessary technical support.
• Partner with Program Management and senior leadership to develop a long-term manufacturing and commercialization strategy for a novel mRNA/LNP product.

Qualifications:

• B.S. with 8–10+ years, M.S. with 7–8+ years, or Ph.D. with 4+ years of directly related experience.
  • Preferred degree fields: Biochemistry, Chemical Engineering, Molecular Biology, Bioengineering, Molecular Medicine, or related disciplines.
• Prior manufacturing or quality experience, including documentation initiation and review, technical writing, etc.
• Proven track record of successfully delivering late-stage CMC initiatives, programs, and business objectives.
• In-depth understanding of CMC, particularly for mRNA and LNP, including process characterization and validation.
  • A demonstrated track record of purifying multiple drug modalities is strongly preferred.
• Experience with technology transfer of manufacturing processes and vendor selection for facility fit and organizational requirements.
• Knowledge of nucleic acid chemistry, enzymatic and chemical reactions, PCR, plasmid processing, and standard analytical techniques for mRNA.
• Ability to support multiple programs at various stages of development concurrently.
• Demonstrated experience working with and holding vendors accountable.
• Willingness and ability to travel as needed, both domestically and internationally.
• Strong track record of completing deliverables within specified timelines.
• Knowledge of GMP, ICH, and FDA regulations is required.
• Independently motivated, detail-oriented, with strong problem-solving abilities.
• Excellent organizational skills.
• Ability to multi-task and thrive in a fast-paced environment with shifting priorities.

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