Job details
Job type full-time
Full job description
At tcr² therapeutics inc, our inclusive and diverse team is passionate about curing cancerWe are a clinical-stage immunotherapy company pioneering the development of novel t cell therapiesOur two lead cell product candidates are being studied in phase 1/2 trials: tc-210 for solid tumors and tc-110 for hematological malignanciesOur research efforts focus on broadening our pipeline with a series of next-generation enhancements that may further improve clinical outcomesWe are headquartered in cambridge, massachusetts, have a clinical manufacturing facility in stevenage, uk, and are building out a new multi-phase manufacturing facility in rockville, mdThis is a global role and will be based in/out of cambridge, ma- opportunity to work remote with travel as required or relocation to boston area.
We are looking for a director/srDirector of quality control to be responsible for building and leading our global quality control (qc) function for clinical-stage cell therapy programsThis will include leadership of internal and external manufacturing qc operations responsible for qc testing of lentiviral vectors and cellular drug product, environmental monitoring, raw materials specifications, and raw material control; ownership of lims and instrument-specific it systems; and the global analytical testing strategyIn addition, this person will work closely with the rockville, md facility design team to establish requirements for the qc testing labs, including appointing and supporting the designated site qc leadership teamYou will report to the vp of quality and be a member of the quality leadership teamThis is a unique opportunity to build an optimized global function and high-performing team!
Responsibilities:
As a member of the quality leadership team (qlt), set goals for both site and function
Develop and implement organization design to support all direct, dotted-line, and cross-functional areas of accountability; including qc testing, environmental monitoring, raw materials control, and laboratory systems
Partner with analytical development to drive the transfer and qualification/validation of qc methods at internal and external sites to ensure harmonization across our manufacturing/testing network, and champion continuous improvement
Partner with analytical development for selection of analytical equipment
Develop and write phase-appropriate global qc policies and proceduresEnsure site accountability for oos, lab and protocol deviations; and implement corrective action plans when necessaryProvide updates as indicated
Ensure effective lab investigations and change control across the tcr2 network
Assist in the preparation of dossiers and data packages, including authorship and review, for interactions between tcr2 and regulatory agencies
Other duties as assigned
Requirements:
Phd molecular biology or biochemist with 7+ years of qc experience, or ms preferred with 10+ years qc management experience, or similar
Proven strong and visible global leadership with the ability and influence other functions within the organization
Demonstrated experience in bioanalytical methods and experience in managing a network of quality control laboratories under gmp compliance.
Proven experience in various analytical techniques including cell-based methods, flow cytometry, elisas, qpcr/ddpcr and other applicable methods to the testing of cellular therapy products.
Experience with technology transfer to internal and external analytical labs and management of method qualification and validation at external sitesKnowledgeable regarding the requirements for analytical testing and phase appropriate qualifications and validations at each stage of clinical development and product approval.
Proven experience in applying gmp in qc lab in conformance to u.s., eu, and row standards, including interfacing with health authority investigators and auditors
Experience in conducting lab investigations, writing deviations, implementing capa and
Initiating change control
Preferred experience: recent industry experience in quality control supporting cell and gene therapy products
Experience building organizations from scratch, including development of organizational design, and hiring of personnel
Experience designing and implementing business processes to meet departmental and corporate needs
Ability to work multifunctionally across a customer-centric organization
Desire to work in a fast-paced growing company!
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