Associate Director/Director, Quality Assurance Operations

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.

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 enthusiastic leader for the role of Associate Director/Director of Quality Assurance Operations. Reporting to the Vice President of Quality, the Associate Director/Director of Quality Assurance Operations will manage and streamline all GMP quality operations across the organization. This individual will collaborate and partner closely with various CMC departments to ensure day-to-day activities maintain compliance with regulations.

Primary Responsibilities:

• Lead the Quality Operations function and build out team and systems to support a risk-based approach to product quality oversight.
• Ensure Quality oversight of all contract manufacturing and contract test organizations and Develop partnerships with CMOs and test laboratories.
• Disposition of Clinical Trial Materials / GMP Materials.
• Review and Approval of material/product specifications, master batch records, executed batch records, stability protocols, stability reports, etc.
• Provide quality oversight for internal and external deviations, CAPAs, change controls, product complaints, shipping excursions, and laboratory OOS or OOT as needed.
• Manage the review and approval of tech transfers, characterizations, method qualifications, validation and verification protocols and reports.
• Perform audits and on-site oversight of suppliers and service providers as needed.
• Escalate quality issues to Head of Quality.
• Collaborate with the Head of Quality on the execution of quality strategy.
• Support the review of regulatory filings.
• Other quality projects as determined appropriate by Head of Quality.

Qualifications:

• 10+ years of quality operations experience in biotech; Experience working in a smaller, fast paced environment along with plant experience highly preferred.
• Working experience and knowledge of GXP regulations and guidelines required.
• Prior experience with establishing and maintaining partnerships with CMOs highly preferred.
• Experience with the review of regulatory submission documentation
• Collaborative, hands-on mindset with strong interpersonal skills with the ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization.
• Strong organizational and time management skills.

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