Manager, External Manufacturing
At TCR Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access. We are headquartered in Cambridge, Massachusetts with an internal manufacturing facility in Rockville, MD. We have a broad Contract Manufacturing Organization (CMO) network throughout the United States. This role can be located in Rockville, MD, or Boston, MA. We are looking for a Manager, External Manufacturing to provide operational and technical support on the oversight of Contract Manufacturing Organizations (CMOs) within our growing external manufacturing network. This person will be accountable for supporting the management of our CMOs on a day to day basis. The Manager, External Manufacturing will work closely with Process Development, Clinical Operations, Quality, and Strategic Sourcing to assure supply of product to our patients.
Responsibilities:
Assist in leading matrixed teams internally and with CMOs to support GMP production, including all production of plasmid DNA, viral vector, and cell drug product. Utilize established business processes and cross-functional relationships with internal/external partners. Maintain internal datasheet that is used to drive internal and external metrics Ensuring that all contractual obligations with our CMOs are met to TCR2 Quality standards, including on-time manufacturing, QC testing, QMS record closure and batch disposition. Authoring and/ or review of Quality System documentation, including technical reports, deviations and change controls. Provide support for process or equipment related issues at the CMO and ensure cross-functional engagement internally. Lead or help drive the resolution of major and critical deviation investigations. Partner with Process Development and Quality to tech transfer and qualify/ validate manufacturing processes and QC methods. Other duties as assigned. Requirements:
Bachelors' Degree in Engineering, Life Sciences or related field. Graduate degree a plus. 5
years relevant experience in life sciences manufacturing, process development, or similar and experience in managing external partners. Experience in biologics or cell/gene therapy preferred. Knowledge of GMP regulations and a commitment to operational excellence. Strong project management, organizational, collaboration, and conflict resolution skills and experience. Experience with technology transfer, technical support, and process characterization/validation preferred. Proven strong and visible leadership with the ability and influence other functions within the organization Experience building organizations from scratch, including development of organizational design, and hiring of personnel is highly desired Experience designing and implementing business processes to meet departmental and corporate needs Ability to work multifunctionally across a customer-centric organization 10% domestic travel anticipated Desire to work in a fast-paced growing company!
Salary Range:
$80K -- $100K
Minimum Qualification
Industrial Engineering, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Assist in leading matrixed teams internally and with CMOs to support GMP production, including all production of plasmid DNA, viral vector, and cell drug product. Utilize established business processes and cross-functional relationships with internal/external partners. Maintain internal datasheet that is used to drive internal and external metrics Ensuring that all contractual obligations with our CMOs are met to TCR2 Quality standards, including on-time manufacturing, QC testing, QMS record closure and batch disposition. Authoring and/ or review of Quality System documentation, including technical reports, deviations and change controls. Provide support for process or equipment related issues at the CMO and ensure cross-functional engagement internally. Lead or help drive the resolution of major and critical deviation investigations. Partner with Process Development and Quality to tech transfer and qualify/ validate manufacturing processes and QC methods. Other duties as assigned. Requirements:
Bachelors' Degree in Engineering, Life Sciences or related field. Graduate degree a plus. 5
years relevant experience in life sciences manufacturing, process development, or similar and experience in managing external partners. Experience in biologics or cell/gene therapy preferred. Knowledge of GMP regulations and a commitment to operational excellence. Strong project management, organizational, collaboration, and conflict resolution skills and experience. Experience with technology transfer, technical support, and process characterization/validation preferred. Proven strong and visible leadership with the ability and influence other functions within the organization Experience building organizations from scratch, including development of organizational design, and hiring of personnel is highly desired Experience designing and implementing business processes to meet departmental and corporate needs Ability to work multifunctionally across a customer-centric organization 10% domestic travel anticipated Desire to work in a fast-paced growing company!
Salary Range:
$80K -- $100K
Minimum Qualification
Industrial Engineering, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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