Director, Analytical Development
The Director, Analytical Development will be responsible for building and leading a team for analytical and platform development for Talaris cell therapy products. Responsibilities include establishing and managing work plans to achieve goals for analytical method development across the portfolio, including application of methods to stability and comparability protocols. The Director will assure lot release and characterization assays are developed and implemented in compliance with FDA regulations and feedback, will assure appropriate method qualification and transfer to QC, and support validation. The Director will author and/or review method sections of CMC regulatory submissions and communications and represent the analytical function in regulatory interactions. The role requires breadth of experience across analytical functions and a history of regulatory interactions regarding parenteral product development. Importantly, the Director will have experience developing assays to quantify strength, purity, and potency for cell therapy products. The successful candidate must have successfully demonstrated leadership, technical proficiency, scientific creativity, initiative, and collaboration with others.
Duties and Responsibilities:
- Serves as the technical and strategic expert for method development for strength, purity and potency attributes of cell therapy products for purposes of lot release and characterization in association with a GMP manufacturing environment
- Provide leadership to the Analytical Development team, including, hiring, mentoring, developing and day-to-day staff management.
- Directs the development of required plans, protocols, and studies to be in place to support the successful optimization and technical transfer of developed methods to internal/external facilities and teams for implementation .
- Ensure that the assays are developed in compliance with phase appropriate GMP expectations: from an early stage through the late-stage requiring the establishment of qualified/validated methods with appropriate controls and well developed control strategy
- Hands-on design and execution of analytical development studies to develop a thorough understanding of operating and performance parameters using QbD approaches.
- Benchmarks to best practices in industry to provide robust, compliant, scalable, and efficient, cost-effective methods for product release
- Represents the analytical development function for authoring, reviewing, and approval of GMP and regulatory documents as appropriate, including SOPs, protocols, reports, specifications, QTPPs, risk and impact assessments, and IND/BLA filing sections
- Collaborates with Talaris Process Development, Manufacturing, Quality and Regulatory functions as well as functional leads to maintain alignment of goals and to navigate project obstacles
- Performs other duties as assigned.
Minimum Education, Training, and Experience Required:
- Ph.D. in a biological science with 8+ years of experience or equivalent
- Hands on experience in biologics development including cell therapy development and late-stage product development
- Breadth of knowledge in cell biology, immunology, cell culture, cell-based assays as applied to development, validation, cGMP, Quality Systems and regulatory requirements for cell therapy
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Experience authoring methods and characterization sections of CMC regulatory documents
- Exceptional teamwork, leadership, and communication skills, with ability to effectively influence others
- Advanced, hands-on analytical skills including the following techniques: automated cell counting, multicolor flow cytometry, cell-based bioassays, etc.
- Experience in QbD including statistical analyses of data
- Experience with data analysis and statistical software, including GraphPad Prism, FlowJo, JMP, etc
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift 15 pounds at times.
- Must be able to access and navigate each department at the organization’s facilities.
- Medical / Dental / Vision Insurance
- Company Paid Long & Short Term Disability
- 25 Days Paid Time Off + 11 Paid Company Holiday’s
- 401k with Employer Contribution
- Paid Parental Leave
- Employee Stock Purchase Plan (ESPP)
- Generous Professional Development Policy for Job-Related External Learning Opportunities
- Employee Assistance Program (EAP)
Talaris Therapeutics requires that all employees be fully vaccinated for COVID-19. Proof of vaccination or sincerely held religious belief and/or medical exemption is required upon hire. Talaris Therapeutics will engage in an interactive dialogue process with employees who have documented medical conditions and/or sincerely held religious beliefs that would prevent them from getting vaccinated, in accordance with all applicable laws.
About Us: Talaris Therapeutics, Inc. (“Talaris”) is a late-clinical stage, publicly traded (Nasdaq Global Market: TALS), biotechnology company that is developing an innovative method of allogenic hematopoietic stem cell transplantation that we believe has the potential to transform the standard of care in sold organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant immune and metabolic disorders. In a ground-breaking, phase 2 study, our lead therapy, FCR001, enabled 70% of living donor kidney transplant recipients to be weaned off all immunosuppression within 12 months of their kidney transplant without rejecting their donated organ. We have followed these patients for an average of over six years since their transplant, and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. We are currently enrolling patients in FREEDOM-1, a randomized, controlled, open-label Phase 3 registration trial in the United States of FCR001 in 120 adult living donor kidney transplant (LDKT) recipients, and in the second half of 2021 we will be initiating FREEDOM-2, in which we will evaluate the potential of FCR001 to induce durable immune tolerance in patients who have previously received a kidney from a living donor, as well as FREEDOM-3 in which we will evaluate the safety and efficacy of FCR001 in adults with a severe form of scleroderma, a debilitating autoimmune disease. We currently have approximately 100 employees and have a corporate office in Boston, MA in addition to our cell processing facility in Louisville, KY.
Equal Employment Opportunity: Talaris Therapeutics is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by emailing us at firstname.lastname@example.org. When emailing, please include a description of your requested accommodation, your name and contact information.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: email@example.com.