Our Purpose: EMPOWER CELLS TO CHANGE LIVES
At SQZ Biotechnologies we believe that our cell therapies will revolutionize the way we treat diseases. Our unique capabilities enable us to engineer almost any function into any cell type, breaking down the barriers in the field, and creating the possibility for cell therapies that could not have been previously envisioned.
- Patients are the Purpose: We strive to transform patient quality of life so they can focus on living.
- Squeeze Together: We are one team with one goal. Only through the sum of our strengths can we achieve our shared purpose.
- Own the Outcome: We are what we do. Integrity and accountability are fundamental.
- Challenge the Now: We fearlessly drive innovation by questioning what is possible, fostering creativity, and executing on our ideas.
SQZ Biotechnologies is seeking an experienced industry expert as a Manager/Senior Manager to join the Quality Assurance (QA) team at SQZ Biotechnology. The successful candidate will assist with the propagation and implementation of the SQZ biotechnology Good Manufacturing Practices (GMP) Quality processes. The candidate will provide hands-on support for QA activities related to clinical supply of cell therapy product(s). The candidate will work cross-functionally across the internal CMC (Chemical, Manufacturing and Control), Clinical, Regulatory teams and with external counterparts within the contract organizations and the clinical site. The candidate will start out as an individual contributor with the potential to lead a team.
- Review batch records, packaging, labeling, and analytical records for raw materials and clinical materials
- Conduct batch disposition and manage all on-demand shipment of clinical materials
- Manage chain-of-Identity and chain-of-custody of all clinical materials, including starting materials
- Manage all change control processes and implementation
- Conduct investigations ensuring effective root cause analysis and assigning of appropriate CAPAs
- Convene material review boards and generate product impact assessments
- Develop quality metrics and provide status reports metrics to department and management
- Support regulatory audits at external cGMP facilities and support regulatory submission documentation
- Build a culture of right first time for autologous clinical trial material manufacture
- Be flexible to meet the QA needs for on-demand clinical trial material manufacture
- Independently and collaboratively multitask in a dynamic multifunctional environment
- Be capable of analyzing a wide variety of data and managing potential compliance risks
- Have a fundamental grasp of the biopharmaceutical drug development processes and scientific methods
- Demonstrate strong leadership skills and experience working with all levels of management
- Fulfill primarily office-based position requiring 0-20% domestic and international travel
- BS in scientific field (Chemistry, Biology, Biochemistry, Chemical Engineering) with 7+ years of increasing QA responsibilities in GMP regulated biotech, pharmaceutical, or CMO organization
- Outstanding communication skills (interpersonal, verbal and written)
- Keen understanding and application of regional regulatory requirements specific to GMPs
- Proficiency in MS Office applications (Word, Excel, Power point, Project) and Quality System Databases
- Experience working in the cell therapy industry
- Experience working directly with the FDA and external regulatory authorities
- Special knowledge and/or licenses or certifications.
SQZ Biotechnologies is proud to be an equal opportunity employer and to provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, SQZ complies with applicable state and local laws governing nondiscrimination in employment. SQZ does not support relocation for this role.