PrincipalSenior Scientist Viral Based Gene Therapeutic Process Development
PrincipalSenior Scientist Viral Based Gene Therapeutic Process Development
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Your role:
MilliporeSigma is seeking a highly motivated and creative individual to be a part of a cuttingedge gene therapy process development team. As part of a dynamic organization and global leader in life sciences the successful candidate will work as a Process Development team member to develop upstream and downstream viral vector processes execute process characterization studies support process validation and execute analytical testing. You will also provide input for areas of innovation new product development and technical representation to advance the field of viral therapy.
- Primary lead and scientific resource for a wide variety of internal and clientdriven projects to develop cGMP compatible viral vector production processes.
- Responsible for understanding the scope of work generating all related documentation executing the studies developing and executing analytical assays analyzing results and writing development reports.
- Interface with clients prior to initiating programs to provide technical guidance as well as throughout the project to provide updates and troubleshooting when needed.
- Support technical process transfers internally and from 3rd party sites.
- Serve as technical subject matter expert with Business Development and Contracting to generate the scope of work for new projects as well as provide projected costing.
- Work crossfunctionally with the Tech Transfer and Manufacturing teams to facilitate the transfer of the processes from Process Development into GMP Manufacturing.
- Support Process Characterization and Process Validation studies.
- Provide technical support during client and regulatory agency site audits as needed.
- Communicate effectively with Technical Operations Leadership team internal and external network partners and the Product Teams.
Who you are:
Basic Qualifications:
- Bachelor of Science in Biology Biochemistry Chemistry Chemical Engineering or other Life Sciences with 15 years of Biotech Pharma Medical Device or Manufacturing work experience
OR
- Masters Degree in Biology Biochemistry Chemistry Chemical Engineering or other Life Sciences with 10 years of Biotech Pharma Medical Device or Manufacturing work experience
OR
- PhD in Biology Biochemistry Chemistry Chemical Engineering or other Life Sciences with 7 years of Biotech Pharma Medical Device or Manufacturing work experience
- 7 years handson experience in Upstream OR Downstream Bioprocessing unit operations and development of analytical assays
- 7 years in cGMP manufacturing and Quality Systems within an FDA regulated environment
Preferred Qualifications:
- Experience with viral vector production at the research and pilot scale mammalian cell culture processes (adherent and in bioreactors) and singleuse systems
- Analytical assay experience (ddPCR ELISA FACS HPLC SDS PAGE)
- Experience with downstream unit operations (clarification tangential flow filtration and chromatography)
- Ability to exercise significant judgment when analyzing complex projects and demonstrate a high level of scientific achievement and understanding
- Experience with JMP or similar software for experimental design and analysis
- Innovative approach to problemsolving and integrated view of business/scientific issues
- Ability to promote a culture of continuous improvement within Process Development; act as champion on initiatives and/or projects to drive improvement in client service
- Ability to lead by example offer scientific coaching and mentoring to other staff members (training and scientific support for ongoing projects)
RSRMS
Required Experience:
Senior IC
Employment Type
Full Time
