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GENERAL SUMMARY OF POSITION:

The Process Development Associate I will be responsible for upstream cell culture process development and downstream biologic purification activities such as the design and execution of laboratory experiments and process optimization, scale-up and technical transfer to cGMP manufacturing for the production of vectored biologic therapies.

MAJOR RESPONSIBILITIES:

• Assists with mathematical modeling, experimental design and data analysis supporting biologic process development.
• Assists with analysis of data by statistical or DoE software, and graphical procedures in order to provide accurate, concise and pertinent summaries and data reports.
• Assists with the scale-up & technical transfer of cell culture and purification processes to GMP Manufacturing.
• Assists with troubleshooting, root cause analysis and identification of corrective actions to support Pharmaceutical Development or GMP Manufacturing equipment and process issues.
• Operation and maintenance of laboratory and pilot-scale cell culture and biologic purification systems.
• Perform analytical biochemistry and molecular biology assays as well as microscopy and other laboratory testing as required.
• Keep accurate records in notebooks, organize and report results.
• Prepare written and oral reports for presentation to the development group and senior staff.
• Maintain reagent inventories, order supplies, cleaning of laboratory areas, hoods, incubators and group equipment.
• Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project strategies. 
• Perform additional job related duties as required.

REQUIRED QUALIFICATIONS:

• Requires a Bachelors degree in Chemical Engineering, Chemistry, Biochemistry or related field with a minimum of 0 to 2 years relevant work experience.
• Prior experience with biologic purification or cell culture and aseptic techniques preferred.
• Excellent written and verbal communication skills
• Familiarity with Microsoft Office & JMP or similar statistical software
• Works on problems of moderate scope where analysis of situation or data requires a review of identifiable factors
• Exercises judgment within defined procedures and practices to determine appropriate action
• Normally receives general instructions on routine work, detailed instructions on new assignments
• Demonstrated ability to work both independently and as a member of a team