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POSITION SUMMARY: 

The R&D Scientist I- Analytical is responsible for developing analytical methods and transferring them to QC laboratories in support of the development and characterization of therapeutic monoclonal antibodies.  This work also supports upstream and downstream process development for in-process control testing.  The R&D Scientist I- Analytical will establish stability programs for drug substance and drug product and develop liquid formulations of monoclonal antibodies.

ESSENTIAL FUNCTIONS:

• Responsible for developing analytical biochemistry assays and other laboratory testing as required.
• Establish stability programs for drug substance and drug product
• Develop liquid formulations of monoclonal antibodies
• Operate and maintain standard laboratory equipment and department-specific equipment. Troubleshoot equipment within scope of experience.
• Ensure that timely and accurate documentation is maintained per cGMP and MassBiologics' SOPs.  Contribute to the development of improved documentation processes.
• Use Excel and Word to analyze data and provide accurate, concise summaries and data reports.
• May contribute to protocols, project summaries and technical reports.
• Prepare written and oral reports for presentation to the supervisor(s) and development group.
• Maintains reagent and equipment inventories, order supplies and clean 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 of business and laboratory systems /processes to support core business activities.
• Responsible for activities required for successful operation of assigned project area including: Writing detailed experimental protocols and Batch Records, coordinating activities in the laboratory, developing Bill of Materials (BOM), executing and documenting experimental studies according to local Standard Operating Procedures (SOPs) or established practices, reviewing and reporting data, and contributing to 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.
• Collaborates and leads interactions with clients, vendors and external partners.

REQUIRED QUALIFICATIONS:

• Requires a PhD in a relevant scientific discipline such as Chemical Engineering, Chemistry, Biochemistry, or other relevant field and 0-2 years of relevant experience in protein purification and characterization. Experience with monoclonal antibody production and purification is preferred.
• Demonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thought. Solid knowledge on scientific principles and concepts.
• Detail orientated with the ability to maintain accurate records and excellent proofreading skills.
• Excellent time management and organizational skills to meet deadlines with minimal supervision.
• Experience with typical column and membrane chromatography, such as affinity, anion/cation exchange, hydrophobic interaction, and/or mixed mode is required
• Extensive experience with AKTA FPLCs.
• Knowledgeable in the principles of biochemical and biophysical analytical techniques such as SDS-PAGE, HPLC, western blotting, IEF, ELISA, differential scanning calorimetry (DSC), and dynamic light scattering (DLS) is preferred.
• Occasional travel is required.
• Unusual hours and weekend work may be required to meet business needs.