- Job Type: Full-Time
- Function: Manufacturing
- Industry: Therapeutics
- Post Date: 09/18/2022
- Email: firstname.lastname@example.org
- Website: talaristx.com
- Company Address: 570 S. Preston St, Suite 400, Louisville, KY, 40202
About Talaris TherapeuticsTalaris Therapeutics, Inc. is a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders.
The Process Development Associate will be responsible for performing laboratory activities to support process development and process characterization of Talaris’ allogenic HSCT products. They will be responsible for supporting cell processing, process engineering scale-up/scale-down, process parameter design space studies, assessment of novel technologies, cryopreservation, and laboratory maintenance. With supervision, the individual will be expected to design and perform experiments, organize and carefully document results, analyze and interpret results, and communicate findings. This role represents an exciting opportunity for technical, career, and personal growth for the motivated individual.
Duties and Responsibilities:
- Contribute to the development of manufacturing processes for HSCT therapy products, including allogenic cell products from different starting sources (apheresis, bone marrow, solid tissues).
- Support the design and execution of process development studies to develop a thorough understanding of operating and performance parameters (design space) and improve the manufacturability of the cell therapy product.
- Document laboratory procedures/experiments with attention to detail in an electronic laboratory notebook.
- Assist in the development and writing of PD lab protocols, batch records, SOPs, and reports.
- Participate in formal and informal tech transfer/knowledge transfer activities with colleagues in research, development, tech transfer, and manufacturing.
- Support evaluations, sourcing, and implementation of more automated solutions.
- Support day-to-day operations of a process development laboratory including ordering of supplies and maintenance of laboratory equipment.
- Performs other duties as assigned.
Minimum Education, Training, and Experience Required:
- Bachelor’s degree with 1+ years of relevant experience; Master’s Degree with 0+ years of relevant experience
- Exceptional teamwork and communication skills
- Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Demonstrated ability to maintain lab execution records and perform data analysis.
- Highly preferred to have aseptic technique experience and experience working in the Biological Safety Cabinet.
- Experience with common equipment used in cell therapy manufacturing such as CliniMACs Plus, CliniMACS Prodigy, NC-202, Controlled Rate Freezer, etc.
- Knowledge and experience in mammalian cell culture / biotechnology related development (aseptic operations, cell biology, biochemistry, immunology)
- Basic data analysis and statistical software, including GraphPad Prism, FlowJo, JMP, etc.
- Flexibility and dedication: Position will require “off-standard hours” including weekends and “on-call” hours as related to specific clinical trials
- 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.
- Competitive compensation including bonus opportunity and equity participation
- Medical / Dental / Vision Insurance
- Company Paid Long & Short Term Disability
- 25 Days Paid Time Off + 10 Paid Company Holiday’s
- 401k with Employer Contribution
- Stock Options and Restricted Stock Units (RSUs)
- Paid Parental and Organ Donor 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.
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 are currently conducting 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, as well as two additional Phase 2 clinical trials: FREEDOM-2, in which we are evaluating the potential of FCR001 to induce durable immune tolerance in patients who have previously received a kidney from a living donor, and FREEDOM-3 in which we are evaluating the safety and efficacy of FCR001 in adults with a severe form of scleroderma, a debilitating autoimmune disease. We currently have approximately 120 employees. We maintain corporate offices in Boston, MA in addition to our cell processing facility in Louisville, KY and our process and analytical development labs in Houston, TX.
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 email@example.com. 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.