Associate Scientist/Senior Associate Scientist, Large-scale Cellular Process Development, closed system manufacturing
bluebird bio is developing potentially transformative, one-time gene therapies for severe genetic and orphan diseases. At the heart of bluebird bio’s product creation efforts is its broadly applicable gene therapy platform for the development of new treatments for diseases with few or no clinical options. bluebird bio has two clinical stage product candidates in development, one for childhood cerebral adrenoleukodystrophy (CCALD) and one for beta-thalassemia major/sickle cell disease, and an early stage oncology program in partnership with Celgene Corporation.
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. The focus of this position is to provide support for the development, qualification and characterization of the stem cell transduction and manufacturing process including the establishment of critical process parameters and controls for manufacturing. We are looking for an innovative scientist with the breadth of experience and drive to implement our vision for this function.
- Executing and optimizing scale-up, and control of autologous/allogeneic stem cell or T-cell therapies for the treatment of a variety of indications within the realm of rare genetic diseases, hematological malignancies and other cancers.
- Assist in designing and testing large scale, closed system manufacturing procedures for therapeutic cell and/or gene therapy products from whole blood, apheresis, or bone marrow.
- Assist in designing and testing methods for the large scale isolation and enrichment of human HSC, ES, iPS, CD4 or CD8 T-cells, and other sub- populations such as TIL’s and or Tregs for therapeutic purposes.
- Responsible for technology transfer from development to GMP contract manufacturing.
- Responsible for drafting process development SOP’s, and working with CMO to draft batch records for drug product manufacturing.
- BS/MS with 3-5 years of experience in translational research , pre-clinical development, or cGMP manufacturing of Phase I/II cellular and gene therapies.
- Have a strong understanding of Immunology and experience with FACS staining and operating various types of flow cytometers.
- Experience with separation techniques using the Miltenyi AutoMACS and CliniMACS automated systems is desirable.
- Experience with common cellular therapy equipment including but not limited to the following, Wave Bioreactors, Haemonetics Cell Saver 5, Elutra, controlled rate freezers, COBE Cell Processors.
- Must be willing to have a flexible schedule based on experimental and company needs (including travel to support technology transfer activities).
- Well versed in a variety of cell based methods have a strong understanding of tissue culture, cell biology, immunoassays, and general laboratory techniques, as well as pertinent experience in the transfer and application of technology in a cGMP environment.
- Prior cGMP cell or gene therapy manufacturing experience for clinical-stage products is highly favorable.
- Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals.
- Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Independently motivated, detail oriented and good problem solving ability.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Willingness to work with lentiviral vector and human biological samples (viral vector biology experience a plus).
- Working knowledge of various computer software, hardware, and standard office sufficient to record scientific data and results, and prepare reports.
- Good understanding of applicable regulations and standards (GMP, GTP and AABB).
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.
This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular. bluebird bio is a well-funded, privately-held, entrepreneurial company backed by prominent investors and recently named to the 2012 FierceBiotech Fierce 15. We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.
To be considered for this exciting career opportunity, please apply through our website. www.bluebirdbio.com
bluebird bio, 840 Memorial Drive, Cambridge, MA 02139
bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.
MassBio is a not-for-profit organization committed to advancing the development of critical new science, technology and medicines that benefit people worldwide.
Founded in 1985, MassBio represents over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.
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