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 a highly-motivated, independently-thinking, Senior Manager to join the process development and manufacturing team. The primary role of the successful candidate will be to support the development of the manufacturing process and the technology transfer of autologous cell therapies to different CMO’s to enable cGMP production of clinical drug product. The successful candidate will develop strong relationships with CMOs, monitor and manage all manufacturing activities and drive teams to achieve clarity on technical issues and deviations as they arise.
- Actively manage SQZ relationship with different Contract Manufacturing Organizations (CMOs) and act as person in plant (PIP) to provide technical oversight and troubleshoot manufacturing issues as they arise
- Responsible for supporting CMC as a functional team representative and assisting in manufacturing clinical deviations and change controls
- Author and review technical documents including standard operating procedures, testing protocols, technical reports, SOP’s, work instructions, master batch records, and technical transfer documents for SQZ and CMOs
- The candidate must develop and maintain detailed project plans, effectively communicate progress and key deliverables across both organizations
- The successful candidate will support authoring relevant CMC sections for IND submissions.
- Support the scale up and development of research-based processes in accordance to regulatory and cGMP guidelines for cell therapies
- Up to 20% domestic travel is required.
- Bachelor’s degree with 9+ years of experience or MS degree with 7+ years of experience in chemical engineering or related technical field or Ph.D. with 5+ years of experience.
- Previous tech transfer experience is required.
- Previous experience managing / mentoring scientists or engineers in a laboratory setting is required.
- Must have a minimum of 5 years’ experience in a cGMP environment.
- Hands on experience with relevant cell therapy equipment.
- Technical understanding and experience in cell therapy process manufacturing operations in an industrial cGMP environment.
- Strong scientific and technical mastery, which includes demonstration of strong technical writing and presentations skills.
- Independently motivated, detail oriented and good problem-solving ability
- Excellent communications skills, mentoring skills, and ability to work effectively in a collaborative team environment
- Excellent organizational skills with an ability to embrace change and multi-task in a fast-paced environment, meet tight deadlines, and prioritize multiple projects
- Direct experience in managing vendors including technical audits, timeline management, cGMP documentation, deviations, CAPA’s, and change controls
- Demonstrate a strong understanding of manufacturing principles, cGMP guidelines, and QBD principles.
- Adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of process data
- Prior work on multi-functional teams and the ability to drive decision-making
- Previous experience working in the cell therapy industry is a plus
- Previous experience in management of cell therapy CMOs is a plus
- Experience with drug product is a plus
- Previous experience with process development and manufacturing support for pre-clinical and clinical phase programs
- Experience supporting manufacturing deviations and change controls as a SME is a plus
- Good understanding of regulations and standards for processing of cellular therapy products and platforms is a plus
- Familiarity and experience working in and overseeing cell therapy manufacturing facilities is preferred
- Capable of addressing production issues in collaboration with quality and regulatory teams
- Direct experience authoring risk assessments, process characterization and process characterization summary / justification reports is highly preferred.
- Conduct investigations in support of manufacturing issues and provide technical oversight for investigations, change control, equipment qualification, and aseptic process validations
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.