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GENERAL SUMMARY OF POSITION:

The VMC Associate II will evaluate, optimize, and execute processes to produce GMP vectored therapeutics. The VMC II is responsible for activities supporting the evaluation & selection of new process and analytical equipment. This position normally receives general instructions on routine work and detailed instructions on new assignments. 

MAJOR RESPONSIBILITIES:

• Designs and executes experiments and analysis supporting development and optimization of vector manufacturing processes
• Executes GMP manufacturing processes according to SOPs and batch records to produce clinical grade vector products
• Contributes to scale up and & technical transfer of bench scale and pilot 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.
• Responsible for the operation and maintenance of Pilot-Scale to GMP scale bioreactor systems.
• Operates and maintains standard laboratory equipment and departmental specific laboratory equipment.
• Perform analytical biochemistry and molecular biology assays as well as microscopy and other laboratory testing as required.
• Performs autoclaving, cleaning and sterilization operations as needed
• Keeps accurate records in notebooks, organizes and reports results.
• Prepares written and oral reports for presentation to the development group and senior staff.
• Completes manufacturing batch records for GMP processes.
• Maintains reagent inventories, orders supplies, cleans laboratory areas, hoods, incubators and group equipment.
• Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project strategies.
• Performs additional job related duties as required.

REQUIRED QUALIFICATIONS:

• Requires a bachelor’s degree in Biology, Chemistry, Biochemistry, Chemical Engineering or related field, with a minimum 2 years of relevant experience, or equivalent.
• Ability to follow instructions precisely , recognize deviations, and recommend corrective action within scope of training
• Prior experience in a cGxP regulated environment. Working knowledge of CFR 21
• Excellent written and verbal communication skills
• 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
• Demonstrated ability to work both independently and as a member of a team
• May require individual to work flexible or extended hours to meet business needs