Senior Engineer I, Gene Therapy - Formulation and Drug Product Development

Biogen
Full time Full day
Cambridge, MA

Job Description




Biogen's Gene Therapy Department is searching for a Senior Engineer I to be a technical leader in its Gene Therapy Drug Product development.  The candidate will be expected to collaborate with other groups within the Gene Therapy, Research Departments, and external collaborators to support new programs and technologies.  Success in this position will require the candidate to enable successful AAV manufacturing through collaboration with partners, internal small-scale development, and provide support for regulatory submissions for early and late phase programs.


Essential Responsibilities:


1)      Independently design, execute and analyze laboratory studies to support GT programs and technology evaluation


2)      Work collaboratively to execute formulation/drug product development studies for AAV gene therapy programs.


3)      Independently manage technical projects to ensure milestones and timelines are met.  Openly communicate across functions and departments while maintaining good collaborative relationships. 


4)      Work collaboratively within the Gene Therapy Department and Program Asset management to drive process establishment as well as relevant documentation to support early and late phase regulatory filings.  Support technical transfer teams to ensure successful manufacturing campaigns at CMO facilities. 


5)      Engage in internal collaborations with other Gene Therapy or Technical Development groups to achieve objectives and implement scientific advancements in the Gene Therapy field.


6)      Provide technical expertise on topics pertaining to formulation/drug product processes.  Presents findings and/or results to senior management, external stakeholders, and industry peers at conferences.


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Qualifications




1)      Expert knowledge of therapeutic products formulation development; development of formulation of adeno-associated viral vector products is preferred.


2)      Demonstrated experience executing formulation, stability, and product characterization studies for late-stage biologics products


3)      Deep subject matter expertise in analytical methods such as AUC, SEC, DSC, and sub-visible particle characterization


4)      Demonstrated experience/expertise in drug product manufacturing process operations such as mixing, sterile filtration, and container filling/closing.


5)      Excellent communication skills and a proven track record of publications and presentations.



Education
Ph.D. and 0-3 years’ experience in Bioengineering, Biochemical Engineering, Chemical Engineering, Biochemistry, or related discipline. A combination of B.S. or M.S. degree with relevant industrial experience in Biopharmaceutical development will also be considered




Additional Information



Biogen's Gene Therapy Department is searching for a Senior Engineer I to be a technical leader in its Gene Therapy Drug Product development.  The candidate will be expected to collaborate with other groups within the Gene Therapy, Research Departments, and external collaborators to support new programs and technologies.  Success in this position will require the candidate to enable successful AAV manufacturing through collaboration with partners, internal small-scale development, and provide support for regulatory submissions for early and late phase programs.

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