SQZ Biotechnologies is seeking a highly-motivated, independently-thinking, Manager/Associate Director to join the process development and manufacturing team. The successful candidate will support the process development efforts for novel cell therapy products. The successful candidate will support the manufacturing function at the company, and lead the technology transfers at different CMO’s to enable cGMP production of clinical products. The successful candidate will develop strong relationships with CMOs, monitor and manage all manufacturing or technical issues and deviations as they arise. Close collaboration with research, assay development and regulatory teams isnecessary.
At SQZ, we're proud of our culture and always look to grow our team with people who share our values. We:
- Squeeze Together: We value teamwork, trust, and transparency as critical components for achieving our mission and exceeding our goals
- Question Boundaries: We’re committed to questioning the status quo and changing the world through our people and our science
- Zap Obstacles: We strive to be pioneers. We’re resilient when it comes to navigating challenges, anticipated or not, scientific and otherwise
- Establish (together with senior management) and manage overall process development and manufacturing strategy for cell-based products
- Oversee all CMO activities, including providing RFPs, obtaining, and selecting bids, contracting, and site performance management
- Oversee the transfer of research-based processes into process development and develop cGMP processes to ensure robust manufacturing at scale
- Develop robust processes to ensure quality and implement ‘in-process controls’ for product development and regulatory requirements
- Ensure appropriate and timely product supply and supply chain management as needed for all preclinical GLP toxicology and clinical studies
- Provide content and generate reports for regulatory filings as needed.
- Manage CMC activities required to ensure successful regulatory filing including process development & manufacturing, analytical characterization, formulation/stability, or other activities as required
- Ensure adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of process data
- BS/MS in biochemical or chemical engineering with a minimum of 5 years of experience in the biotechnology or pharmaceutical industry
- Demonstrated experience in process development and manufacturing functions for cGMP production of cell therapy products
- Experience with aseptic manufacturing
- Prior success with process development and technology transfer to manufacturing for a cell therapy product
- Provide oversight and write documents to support regulatory filings.
- Effective communicator of ideas, project goals and results both internally and externally
- Strong organizational skills and the ability to successfully manage multiple technical projects and priorities at the same time
- Travel up to 25%
- Direct experience overseeing or implementing Quality in the process development and manufacturing fields
- Overseen manufacturing process troubleshooting to ensure continued delivery of high-quality products
- Addressed production issues in collaboration with quality and regulatory teams. Conduct investigations in support of manufacturing issues
- Conducted process validation at scale, from writing protocols through execution across the drug substance manufacturing network
- Provided oversight and support for technical investigations and change controls.
- Defined relevant operational/technical standards and practices for manufacturing sites
- Defined raw material and consumable specifications and standards for manufacturing
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.
Location/Region: Watertown, MA