Senior/Principal Scientist - AAV Analytics

Proclinical is currently recruiting for a Senior/Principal Scientist of AAV Analytics with a biotechnology company located in Cambridge, MA. Successful candidate will participate in the comparison of AAV vector products produced internally with those produced externally as well as the optimization and qualification of molecular and bioanalytical assays such as immunoassays and cell-based assays.

Job Responsibilities:

• Execute analytic strategy for release and characterization of AAV gene therapy vectors, efficiently and independently.
• Establish a team responsible for implementation of molecular and cell-based assay platforms to support rapid advancement of multiple programs.
• Accountable for the development of robust characterization assays for AAV process development and product release assays.
• Implementation of novel process analytical technologies, including automation and high-throughput screening.
• Effectively collaborate with a fully integrated team to facilitate the success of projects, as well as, assists other outside of own project with troubleshooting and methods development.
• Provides technical recommendations broadly within the company regarding own field and plays a key Project Role.
• Execute and optimize AAV-specific characterization assays, including vector genome quantification by qPCR and ddPCR, viral infectivity by TCID50 and viral vector potency.
• Contributes to the writing of technical reports, protocols and any other technical documentation necessary.
• Generates, manages, evaluates, and maintains critical data in a highly organized manner.
• Assists with technology transfer to contract manufacturing organizations by generating data and reports as well as providing on-site technical support.
• Identifies complex technical issues and implements solutions.
• Adept at conducting routine testing and able to conduct limited troubleshooting of multiple methods.
• Able to effectively manage and prioritize multiple parallel laboratory activities is essential.
• Able to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
• Experience working in Quality Control or understanding of GLP and GMP practices a plus.
• Familiarity of Electronic Lab Notebook (ELN) and Laboratory Information Management Systems (LIMS) a plus.
• Experience with method transfer to external testing organizations to support characterization and release of clinical stage products is preferred.
• Independently motivated, detail oriented and good problem-solving ability.

Skills and Responsibilities:

• PhD in Biochemistry, Cell & Molecular Biology, Genetics or related discipline and greater than 3 years' experience or Master's degree and 5+ years' experience will be considered.
• Hands-on experience with a variety of bioassays, including cell-based assays, ELISAs, TCID50 and qPCR preferred.
• Extensive practical knowledge of a broad range of analytic tools for quantification and characterization of AAV vectors.
• Experience contributing to CMC strategy through participation on global development team.
• Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team.
• Demonstrated ability in applying innovative approaches to solving complex biological problems.
• Experience with gene therapies using viral approaches is preferred but not required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Max Robinson at (+1) 929-388-1651 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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