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Manager, QA Operations

5 months ago

Waltham, United States TScan Therapeutics Full time
Job DescriptionJob Description

Position Summary:

TScan Therapeutics is a startup biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Quality Assurance (QA) professional to join our team as QA Operations Manager supporting our internal GMP Cell therapy manufacturing. This position will be based in our cGMP Manufacturing site in Waltham, MA and will directly support cGMP Clinical Cell Therapy manufacturing and commercialization activities.

The Manager is a hands-on manager that provide quality support of manufacturing, Quality Control, Supply Chain Material Receipts and Inventory Management and Facilities, with a focus on supporting real-time triaging and documentation review. The ideal candidate will have experience working in a GMP Manufacturing facility, experience with cell and gene therapy, and enjoy a fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.

This position may include 20-30% of weekend work (either Saturday or Sunday) to support Clinical Manufacturing.

Responsibilities:

Responsibilities include but are not limited to:

  • Manages, coaches, and develops the growing team of QA Specialists
  • Provide QA oversight of production, QC, and supply chain operations through review/approval of test records for batch release, SOPs, C of As (as applicable), CAPAs, Deviations, change controls, and on the floor oversight. Provides the production, QC, MSAT, and supply chain teams with QA/Compliance guidance and decisions
  • Review and approval of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation/qualification related matters.
  • Review and approve actions related to facility, computerized systems, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted. Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC remediation work.
  • Review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans related to manufacturing operations, as needed. Contribute to generation of Annual Product Reviews for production, QC and supply chain.
  • Support training program for QA operations specialists which include training curricula, raw material dispositions, batch issuance, and batch record review and release training curriculum as well as operational quality systems and compliance.
  • Drive continuous quality improvement program for manufacturing operations and partner with the production, QC, and supply chain teams to implement/optimizes to improve efficiency (right the first time) and monitor/escalate as needed.
  • Actively drive high quality deliverables at the site by promoting a high standard of Quality Culture. Helps build and drive a culture of compliance throughout the organization.
  • Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
  • Act as a Deputy to Quality Assurance Operations Head.

Requirements:

  • BS degree in a relevant scientific discipline required, at a minimum.
  • 8-10+ years of relevant biotech/pharma industry experience, with at least 3 years combined of relevant experience in Aseptic GMP manufacturing Operations and Quality Assurance covering GMP manufacturing operations.
  • Experience with supervising/managing direct reports
  • Proven track record and practical experience in supporting a GMP Manufacturing Operations unit and operating in full compliance with global cGMP requirements. Successfully managed inspections by major Health Authorities (e.g., US FDA, EMA).
  • In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH regulations. In depth knowledge of QC regulations.
  • Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity.
  • Strong data tracking, trending, and analysis skills.
  • Strong communications skills, a team player who can lead, mentor, and inspire others
  • Gene or cell therapy product experience preferred
  • Demonstrated success in delivery of key milestones against tight timelines
  • Ability to prioritize, manage time well, multitask, troubleshoot

About TScan:

TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan’s discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.

Do YOU have the anatomy of a TScanner?

Our talented, compassionate and intelligent team is what makes TScan a great place to work. Our brand new offices with approximately 40,000 square feet of premium lab and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today