Unique opportunity to join an exciting, mid-stage biotechnology company
Job Title: Director, Manufacturing Operations
Location: Louisville, KY
Talaris Therapeutics, Inc.(“Talaris”) is developing a breakthrough, one-time cell therapy to enable patients who receive a living donor kidney transplant to no longer require lifelong immunosuppression, without rejecting their donated organ. Achieving durable, drug-free immune tolerance to a donated organ has been referred to as a “Holy Grail” of organ transplant. In a ground-breaking, phase 2 study conducted between 2008 – 2016, our lead therapy, FCR001, enabled 70% of patients to be weaned off all immunosuppression within 12 months of their kidney transplant. No tolerized patient has had to resume immunosuppression. We have followed these patients for an average of almost five years since their transplant, and the longest for over ten years. Our single-dose cell therapy has also shown the potential to induce durable remission of certain types of severe auto-immune diseases, and to benefit other solid organ transplant patients. Talaris recently closed a $100M private financing from leading life sciences investors. We will be initiating a Phase 3 pivotal trial of our therapy in living donor kidney transplant patients later in 2019. We will also be initiating two Phase 2 trials of our therapy in additional indications in 2020. Our cell processing facility and most of our operations are based in Louisville, KY, and we also have a corporate office in Boston, MA.
This newly created role, based in Louisville, KY, will report to Senior Vice President of Technical Operations. Talaris offers competitive compensation, benefits and stock options, as well as relocation compensation.
The Director of Manufacturing Operations is responsible for the management of aseptic cell processing operations, including production, supply chain, and inventory management, conducted within the Talaris manufacturing facility. The facility is a state-of-the-art, GMP and GTP compliant, controlled clean room facility designed for the production of novel regenerative medicine products. The Director is also responsible for planning manufacturing operations and for managing a team of production professionals conducting cell processing in a reproducible manner to meet clinical demand, and established criteria for safety and quality. The position requires an exceptional technical leader with a thorough understanding of cell-based methodologies, a solutions-oriented approach to problem solving, and outstanding team management skills.
- Plan and manage manufacturing operations conducted within the Talaris facility in a manner that assures reproducibility and compliance with 21 CFR 210, 211 (Good Manufacturing Practices) and 21 CFR 1271 (Good Tissue Practices); serve as responsible head of manufacturing operations
- Develop departmental strategic plans in line with company objectives and prioritize projects with an emphasis on compliance, execution, adherence to detail, and continuous quality improvement
- Develop a strong team of highly skilled professionals responsible for conducting aseptic processing operations; define roles, establish expectations, support career development, and manage performance
- Coordinate manufacturing operations with Quality Assurance, Quality Control teams and administration to assure seamless integration of operations, timely batch record review, and product release
- Lead the development of process characterization and validation strategies and execution in preparation for Food and Drug Administration (FDA) Biological License Applications.
- Collaborate with R&D scientists at Talaris to coordinate research processes and integrate operations to prepare for production of cell therapy products for new indications
- Work closely with Regulatory and Quality staff within and outside of Talaris to build consensus on approaches to assure compliance with regulatory requirements.
- Represent Talaris during third party inspections, including Food and Drug Administration inspections
- Analyze manufacturing capacity and develop recommendations for team structure, manufacturing timelines, and operational improvements necessary to meet clinical demand
- Manage manufacturing activities in accordance with available budget, resources and personnel
- Play significant role in interviewing, hiring and training manufacturing staff
- Conduct root cause analysis of deviations from normal operations and implement corrective actions where required
- Review and approve technical and regulatory reports, new SOP’s and significant SOP revisions
- Review vendor contracts on behalf of Talaris; ensure vendors meet terms of negotiated contracts
- Maintain substantial current technical knowledge related to all procedures relevant to cell processing and analysis, aseptic processing operations, regenerative medicine product manufacturing and other relevant fields
- Perform additional job-related duties as required
- A PhD or equivalent job experience in biologic sciences with 10+ years of experience in cell therapy, gene therapy, blood or cell processing, or related field.
- Previous experience leading and managing manufacturing processes within a cGMP/cGTP compliant biotech, cell processing (i.e., somatic cell or bone marrow processing), or tissue bank facility
- Thorough understanding of the field of cell therapy processing and cryopreservation, and applicable statistical techniques, Design of Experiment, and data analysis.
- Thorough understanding of applicable regulations and standards for processing of cellular therapy products for Phase I, II, and III trials (GMP, GTP, AABB, FACT) and experience with regulatory inspections
- Strong technical writing skills, including preparation of validation and qualification studies, batch records
- Relevant experience with process transfers and validation of cell therapy technology preferred
- Experience with regulatory fillings for INDs and BLAs preferred
- Demonstrated ability to effectively manage performance, set and prioritize departmental goals
- Excellent time management and organizational skills, demonstrated ability to manage multiple projects and meet deadlines
- Background in flow cytometry and familiarity with common cell processing equipment and techniques including use of CliniMACS, preparation of sterile media, and aseptic technique is a plus
- Ability to work effectively in a fast-paced, rapidly changing environment
- Excellent people skills, with demonstrated ability to manage a diverse team and communicate effectively across functional groups
- High level presentation and writing skills, with experience reporting to senior leadership
- Experience working in both academic and corporate settings a plus
- Willing to have a flexible schedule when needed and travel domestically and internationally on occasion
Apply: Please submit resume or CV and cover letter to hiring@Talaristx.com
Talaris is an equal opportunity employer and prohibits unlawful discrimination.