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POSITION SUMMARY: 

The R&D Scientist I - Downstream is responsible for the design and execution of experiments in cell clarification, chromatography, ultrafiltration/diafiltration, and filtration of protein therapeutics. The candidate is expected to develop and optimize purification processes, define process parameters, limits, and ranges, and troubleshoot manufacturing process. The R&D Scientist I - Downstream is also responsible for evaluating new process technologies for implementation in cGMP manufacturing.

ESSENTIAL FUNCTIONS:

• Designs, optimizes and characterizes protein isolation and purification processes. Defines purification procedures and operation specifications. Utilizes standard chromatography techniques and other appropriate unit operations as required.
• Supports process development for contract manufacturing and internal projects
• Ensures that all work is properly documented and suitable for regulatory submission.
• Drafts technical reports to support technology transfer, regulatory and intellectual property submissions.
• Maintains substantial knowledge of state-of-the-art principles in antibody purification, formulation and validation.
• Provides technical guidance and leadership to process development staff.
• Manage process development projects and supervise junior process development personnel
• Works on problems of moderate scope where analysis of situation or data requires a review of identifiable factors.  Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solution. Normally receives general instructions on routine work, detailed instructions on new assignments.
• Perform additional job-related duties as required.

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.