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SUMMARY OF POSITION:

The Research Associate III, Process Development - Analytical is responsible for conduct of analytical assays that support Process Development and characterization of vaccines, gene therapy products and therapeutic monoclonal antibodies.  The incumbent will perform established assays and contribute to the development of new assays. This work also supports upstream and downstream process development for in-process control testing.  The R&D Associate III, Process Development - Analytical will establish stability programs for viral vectors, drug substance and drug product and develop liquid formulations of monoclonal antibodies.

MAJOR RESPONSIBILITIES:

• Performs wide range of analytical biochemistry assays and other laboratory testing as required. Techniques include HPLC/UPLC, qPCR, DLS, SDS-PAGE, CE, and ELISA.   
• Operates and maintains standard laboratory equipment and departmental specific equipment. Troubleshoots equipment within scope of experience.  
• Ensures timely and accurate documentation in accordance with cGMP and MassBiologics' SOPs.  Contributes to the development of improved documentation processes.  
• Analyzes data in Excel and DOE software, and provides accurate, concise data summaries
• Responsible to write protocols, project summaries and technical reports.
• Reviews laboratory notebooks and logbooks. 
• Responsible for training new employees on areas of technical expertise and compliance issues relevant to the lab setting. 
• Understands and applies principles of biosafety to maintain a safe workplace for self and others. 
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and MassBiologics Policies and Standard Operating Procedures. 
• Supports Collaboration and interactions with clients, vendors and external partners. 
• Prepares written and oral reports for presentation to the supervisor(s) and development group. 
• Maintains reagent and equipment inventories, orders supplies and cleans laboratory areas, hoods and common equipment.  
• Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project strategies within defined parameters.   
• Performs additional job-related duties as required.

REQUIRED QUALIFICATIONS:

• Requires a bachelor’s degree in Molecular Biology, Chemistry, Biochemistry, or related field with a minimum 5-7 years of relevant experience.  
• Hands on experience with qPCR, HPLC and Capillary Gel Electrophoresis is preferred.  
• Ability to follow instructions precisely, recognize deviations, and recommend corrective action within scope of training. 
• Ability to troubleshoot within scope of training.  
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems. 
• Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills.  
• Strong critical thinking, time management and organizational skills.  Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines.  
• Excellent written and verbal communication skills.  Ability to communicate effectively with others.  
• Ability to work effectively both independently and as a member of a team. 
• Occasionally projects require flexibility in work schedule to meet business needs.