USA-Research Associate I (Scientific)
Position Overview/Department Description The Sanofi Genetic Medicine Unit CMC organization is responsible for the design and optimization of viral vector and cell therapy manufacturing processes and platforms.
A key function of this group is to establish operational excellence in the manufacturing of Sanofis emerging portfolio of gene therapy products supported by a diverse panel of analytical methods to provide process understanding and product characterization.
The BioProcess Analytics support group located in Waltham MA is responsible for execution of analytical methods to support manufacturing and development activities building process understanding and supporting life cycle management from early to late stage clinical entry.
The Research Associate Analytical Technician is responsible for executing test methods under control of established procedures.
We are looking for a candidate that has experience in an analytical setting that can independently manage and execute their testing schedule supportive of genomic medicines process development.
In addition they should possess the skills to interpret and communicate their data with the appropriate development teams.
The Position is primarily for 1 year with a high possibility for an extension for another year.
Key
Responsibilities:
Execute test methods following established procedures Life cycle management of established procedures Work with Process Development groups to design testing packages around studies targeting key information Manage testing and training deliverables against defined schedules Maintain all documentation and reports including assay documentation training folders and assay databases Contribute to assay investigations for out of expectation results or test failures working with manager and customers on root cause analysis and mitigation strategies Lead or support assay transfers as part of a cross functional team Support maintenance of facility infrastructure and management of inventories for assay supplies reagents controls and standards.
Perform data analyses and contribute to technical reports protocols and internal/external presentations Attendance at GMU and inter-departmental meetings and work streams as needed Potential for occasional weekend and holiday work to support ongoing lab activities Basic Qualifications BS in biological sciences or related field with 0-3 years of relevant experience biotechnology or pharmaceutical industry.
Experience in an analytical setting and executing assays relevant to qPCR and cell culture.
Excellent organization and documentation skills committed to internal documentation practices Preferred Qualifications Basic knowledge and practical experience in cellular molecular and chemistry analytical methodologies including but not limited to ddPCR Bioassay/Potency assays and others as applicable.
Practical experience in aseptic technique in a variety of cell line maintenance techniques is preferred Relevant knowledge of Gene Therapy analytics methods is preferred especially methods used to characterize Adenovirus and Adeno-Associated Virus vectors Experience with automation technology platforms is desired Experience and knowledge of working with biohazard infectious agents is preferred Recommended Skills Asepsis Biotechnology Clinical Works Data Analysis Databases Hardworking And Dedicated Estimated Salary: $20 to $28 per hour based on qualifications.
A key function of this group is to establish operational excellence in the manufacturing of Sanofis emerging portfolio of gene therapy products supported by a diverse panel of analytical methods to provide process understanding and product characterization.
The BioProcess Analytics support group located in Waltham MA is responsible for execution of analytical methods to support manufacturing and development activities building process understanding and supporting life cycle management from early to late stage clinical entry.
The Research Associate Analytical Technician is responsible for executing test methods under control of established procedures.
We are looking for a candidate that has experience in an analytical setting that can independently manage and execute their testing schedule supportive of genomic medicines process development.
In addition they should possess the skills to interpret and communicate their data with the appropriate development teams.
The Position is primarily for 1 year with a high possibility for an extension for another year.
Key
Responsibilities:
Execute test methods following established procedures Life cycle management of established procedures Work with Process Development groups to design testing packages around studies targeting key information Manage testing and training deliverables against defined schedules Maintain all documentation and reports including assay documentation training folders and assay databases Contribute to assay investigations for out of expectation results or test failures working with manager and customers on root cause analysis and mitigation strategies Lead or support assay transfers as part of a cross functional team Support maintenance of facility infrastructure and management of inventories for assay supplies reagents controls and standards.
Perform data analyses and contribute to technical reports protocols and internal/external presentations Attendance at GMU and inter-departmental meetings and work streams as needed Potential for occasional weekend and holiday work to support ongoing lab activities Basic Qualifications BS in biological sciences or related field with 0-3 years of relevant experience biotechnology or pharmaceutical industry.
Experience in an analytical setting and executing assays relevant to qPCR and cell culture.
Excellent organization and documentation skills committed to internal documentation practices Preferred Qualifications Basic knowledge and practical experience in cellular molecular and chemistry analytical methodologies including but not limited to ddPCR Bioassay/Potency assays and others as applicable.
Practical experience in aseptic technique in a variety of cell line maintenance techniques is preferred Relevant knowledge of Gene Therapy analytics methods is preferred especially methods used to characterize Adenovirus and Adeno-Associated Virus vectors Experience with automation technology platforms is desired Experience and knowledge of working with biohazard infectious agents is preferred Recommended Skills Asepsis Biotechnology Clinical Works Data Analysis Databases Hardworking And Dedicated Estimated Salary: $20 to $28 per hour based on qualifications.
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