Manager, Process Development

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. 
 
Our Values: 
  • 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. 

The Role:
SQZ Biotechnologies is seeking two highly-motivated, independently-thinking Managers to join the Process Development and Manufacturing team. Reporting to the Associate Director and Senior Manager, the successful candidates will 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 candidates 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. 
 
Responsibilities:
  • Actively manage SQZ relationship with different CMOs and act as person in plant (PIP) to provide technical oversight and troubleshoot manufacturing issues as they arise
  • 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 Contract Manufacturing Organizations (CMOs)
  • Develop and maintain detailed project plans, effectively communicating progress and key deliverables across both organizations
  • Support authoring parts of the 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
  • Ability to design complex and multi-component experiments and DOEs in support of various process development activities for novel cell therapies

Minimum Qualifications:
  • Bachelor’s Degree in chemical engineering or related technical field with at least 5 years of experience or MS degree with at least 3 years of experience field or Ph.D. with at least 1 year of experience
  • Previous tech transfer experience is required. Experience with drug product is a plus
  • Must have previous a minimum of 2 years of experience in a cGMP environment
  • Demonstrates 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.
  • Outstanding communication skills (interpersonal, verbal, and written)
  • Prior work on multi-functional teams and the ability to drive decision-making
  • Up to 25% domestic travel is required

Preferred Qualifications
  • Previous experience working in the cell therapy industry is a plus
  • Previous experience in the management of cell therapy CMOs is a plus
  • Previous experience with process development and manufacturing support for pre-clinical and clinical phase programs
  • Capable of addressing production issues in collaboration with quality and regulatory teams
  • 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.  

Want to apply later?

Type your email address below to receive a reminder

Apply to Job

ErrorRequired field
ErrorRequired field
ErrorRequired field
Error
Error
insert_drive_file
insert_drive_file