Materials Science & Technology (MSAT) Technician

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Job description

Primary roles include collaborating in Technology Transfer from Process Development (PD), Process Characterization and Process Improvement (PI) into GMP Manufacturing. This position will also maintain secondary responsibilities for operations related to clinical cell therapy manufacturing in a GMP and GTP compliant ISO 7 classified cleanroom facility.

Duties and Responsibilities:

• Assist in scale-up analysis of PD/PI scale projects to GMP manufacturing scale
• Assist in development of PD/PI lab protocols, batch records, SOPs, and reports.
• Assist in development and execution of Technology Transfer documents

• Assist in training Manufacturing personnel on subsequent changes to current GMP manufacturing processes.

• Assist in evaluating the PD/PI potential of new technologies, assays and clinical research protocols
• Optimize tissue extraction/processing parameters to improve quality and quantity of harvested cells
• Assist in conducting data analysis and preparing reports
• Demonstrates strong aseptic technique
• Participate in clinical manufacturing of FCR001
• Participate in the design and implementation of validation and qualification studies
• Participate in programmatic organization activities such as equipment maintenance, inventory management, ordering of supplies
• Responsible for maintaining training requirements up to date
• Completion of Non-conformances and investigations
• Experience with GMP equipment to troubleshoot
• Assist in the training of new personnel
• Coordinate with Material Management to maintain inventory levels for PD/PI processes
• Performs other duties as assigned.

Minimum Education, Training, and Experience Required:

• A bachelor's degree in the science field or equivalent combination of education and training, with 1-3 years of experience within cell therapy, gene therapy, or cell processing
• Experience in cell culturing, cell processing, blood banking, or transfusion service preferred
• General understanding of hematology and immunology concepts
• An equivalent combination of education, training, and/or professional experience may be considered in substitute for requirements listed
• Working knowledge of Good Manufacturing Practices (GMP), Good Tissue Practices (GTP), or American Association of Blood Banks (AABB) standards

Additional Qualifications

• Ability to work effectively in a fast-paced, rapidly changing environment
• Flexibility and dedication: Position will require "off-standard hours" and "on-call" hours as related to specific clinical trials, including some nighttime hours during manufacturing; may require overtime
• This position requires a general occupational health screening performed by an approved occupational health unit to work with the "open product" in the bone marrow processing cGMP facility. These examinations are necessary to protect the "open product" during the bone marrow processing. Applicants who intend to work with open product shall not submit to a health screen until after an offer of employment has been made

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift 50 pounds at times
• Ability to gown to work in a cleanroom environment (ISO 8, 7, 5)
• Must be able to access and navigate each department at the organization's facilities
• Ability to work some irregular hours, including evenings or weekends, depending on workload

Benefits:

• 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 . 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: .