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                    Scientist/Senior Scientist, Shipping & Transportation

                    Voyager Therapeutics
                    Cambridge, MA 02138
                    Full-time, Part-time
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                    Job Description

                    Voyager is looking for exceptional individuals who share our passion for developing life-changing gene therapies for severe neurological diseases.

                    Current Openings

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                    Note to Employment Agencies: Please do not forward agency resumes. Voyager Therapeutics is not responsible for any fees related to resumes that are unsolicited and out of executed contracts.

                    Voyager Therapeutics will only accept job applications from candidates who are properly documented with authorization to work in the United States.

                    Scientist/Senior Scientist, Shipping & Transportation

                    Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV gene therapy through innovation and investment in vector engineering and optimization, manufacturing and dosing and delivery techniques. Voyager's pipeline focuses on severe neurological diseases in need of effective new therapies, including Parkinson's disease, a monogenic form of ALS called SOD1, Huntington's disease, Friedreich's ataxia, neurodegenerative diseases related to defective or excess aggregation of tau protein in the brain including Alzheimer's disease and other tauopathies, neurodegenerative diseases related to defective or excess aggregation of alpha-synuclein protein in the brain including Parkinson's disease and other synucleinopathies, and severe, chronic pain. Voyager has strategic collaborations with AbbVie and Neurocrine Biosciences. Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager Therapeutics is headquartered in Cambridge, Massachusetts.

                    Voyager is seeking a highly motivated Scientist/Senior Scientist to join the Drug Product Sciences group within the Technical Operations organization with a focus on cryogenics and transportation processes for late-stage gene therapy products. The qualified candidate will be a Subject Matter Expert within the group with a strong expertise in drug product manufacturing of biologics and will provide support for drug substance/product packaging/shipping across the Voyager network. This individual will be a member of the Drug Product Sciences group within the Biopharmaceutical Development organization based in Cambridge, MA

                    Responsibilities

                    • Serve as a subject matter expert for cryogenics and transportation processes of commercial and late stage biologics drug substance/product across Voyager's network and contract storage/manufacturing sites for drug substance/product packaging/shipping.
                    • Select, develop, and implement packaging concepts and technologies for new and existing products with specific focus on packaging systems for active and passive cold chain distribution.
                    • Collaborate with third parties for planning/execution of outsourced shipping studies. Participate in design and execution of shipping validation studies (IQ/OQ/PQ) for transportation of bulk drug substance, drug product vials and analytical samples across different sites and contract manufacturing organizations. These studies will include conducting risk assessment(s), authoring study protocols, executing shipments, compiling, and analyzing data, and authoring technical report(s). Appropriate GLP/GMP procedures must be followed.
                    • Support cryogenics and transportation related site investigations, impact assessments, change controls, health authority inspections, and continuous improvement of cold-chain processes at Voyager and contract manufacturing organization partners.

                    Qualifications

                    • A minimum of a BS, MS, or PhD degree in Biological or Chemical Sciences/Engineering, Packaging Engineering, Pharmaceutical Sciences, or related disciplines is required. A BS with 8 plus years of related experience, a MS with 6 plus years of related experience, or PhD with 2 plus years of related experience is required.
                    • Demonstration of expertise in heat transfer fundamentals is required.
                    • Knowledge of shipping qualification, transportation and packaging design is preferred.
                    • Knowledge of protein dynamics and stability, especially the effects of freezing and thawing on protein stability, is desirable.
                    • Knowledge of common protein analytical tools and demonstrated experimental skills for lab work is required.
                    • Excellent verbal & written communications skills are desired
                    Are you legally authorized to work in the United States?  *
                    --

                    Will you now or in the future require sponsorship for employment visa status (e.g., H-1B visa status)?  *
                    --

                    If you answered 'Yes' to the previous question, what is the specific Visa and how long is your authorization to work?  *

                    Posting ID: 566864008Posted: 2020-08-09