Logistics Specialist

Job description

The Logistics Specialist is responsible for the coordination and planning of the vein-to-vein logistics of shipping and receiving patient-specific allogenic cell therapy starting material and drug product at Talaris Therapeutics. The Specialist is knowledgeable of biological tissue and sample collection, logistics and transportation of samples, various courier services, clinical research operations and a general understanding of patient care and treatment scheduling and management.

Duties and Responsibilities:

• Coordinate logistics, shipping and receiving, for patient-specific allogenic cell therapy starting material and drug product in compliance with Talaris procedures and GxP regulation including 21CFR Parts 11, 210, 211, 312, 600, and 1271
• Communicates study requirement while ensuring adherence to the cell journey process
• Responsible for identifying refinement and improvement of the cell journey process and proactively identifies potential study issues/risks and recommends/implements solutions
• Identify potential logistics issues and risks that may impact patient safety
• Ensure timely product release and on-time shipments of Drug Product (DP) to clinical study sites
• Coordinate Starting Material, Drug Substance (DS) and Drug Product (DP) shipments
• Responsible for maintaining courier and clinical site relationships
• Responsible for daily monitoring, input, and coordination of vein-to-vein logistics systems
• Collaborate with internal and external parties to establish and maintain consistent, timely and accurate reporting of clinical material using the vein-to-vein platform
• Resolve shipping and logistics delays and other challenges
• Provide support to the planning and scheduling of products and starting materials
• Works closely with couriers to ensure that shipments are processed in a manner that is compliant with global customs regulations, including but not limited to the proper coding of clinical material, generation of customs documents, and application for import and export permits, as necessary
• Responsible for completing deviations, performing investigations, CAPA implementation and continuous improvement of logistics SOPs
• Support non-clinical and R&D work as it relates to managing and facilitating the cell journey processes
• Proactively communicates with site research staff, vendors, and manufacturing to facilitate the 'cell journey' activities as well as initiation and completion of study treatment and subsequent patient visits
• Performs other duties as assigned.

Minimum Education, Training, and Experience Required:

• Bachelor's Degree in business, supply chain, or related discipline with 3-4+ years of relevant experience
• Knowledgeable of the Code of Federal Regulations (CFR) and Current Good Manufacturing Practices (cGMPs)
• Excellent written and verbal communication skills
• Ability to build and maintain relationships and rapport
• Excellent time management and organizational skills with a demonstrated ability to meet deadlines
• Experience working with complex schedules and priorities in dynamic environments
• Must be able to work on off-shift hours
• Ability to travel as necessary

Additional Qualifications

• Ability to work effectively in a fast-paced, rapidly changing environment
• Experience with both paper-based and electronic systems
• Ability to multitask on a daily basis and maintain multiple projects in parallel
• Willing to have a flexible schedule when needed
• Excellent people skills, with demonstrated ability to communicate effectively across functional groups and manage relationships
• High level presentation and writing skills, with experience presenting to functional teams
• Excellent time management and organizational skills, demonstrated ability to manage multiple projects and meet deadlines
• Experience with electronic systems (ERP and QMS)
• Self-motivated with a strong sense of ownership in area of responsibility

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift 50 pounds at times.
• Must be able to access and navigate each department at the organization's facilities.

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: .