Research Associate, Process Development

Job Description

• Understands product requirements by studying and implementing oligonucleotide project objectives and targets related to engineering and chemical requirements.
• Leads project development by developing synthetic routes, methods, and techniques in preparing, separating, purifying, analyzing, quantifying and resolving oligonucleotide process components and objectives.
• Maintains process compliance integrity by adhering to standard operating procedures (SOP's) and current good manufacturing practices (cGMP) as appropriate.
• Documents analyses by completing experiment notebooks and records; implementing process chemistry applications and analyzing results of new oligonucleotide synthesis and purification methods and processes.
• Sets-up and operates laboratory equipment by following operating instructions; troubleshooting instrumentation and method issues. Applies laboratory experience in chemistry and separations to issues of process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing.
• Executes Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments to support design space understanding and process validation as they relate to oligonucleotide synthesis, process chromatography, and other purification and isolation techniques.
• Leads the preparation of milligram to gram quantities of active pharmaceutical ingredient (API) to support early-stage (Pre-clinical) development and toxicology studies.
• Prepares process descriptions and the writing of writes technical reports to support internal technology transfer into manufacturing and support in preparation of client CMC submissions.
• Improves job knowledge by understanding emerging trends in oligonucleotide analytical methods and synthesis development; reviewing professional and technical publications; establishing personal networks and benchmarking state-of-the-art practices.

Qualifications

• Bachelor’s or Master’s Degree in chemistry, chemical engineering, science or equivalent or a combination of education and or experience
• Post-graduate, certification, and/or license may be required.
• 4+ years relevant experience for entry to this level with preference to experience in a pharmaceutical environment.
• Previous knowledge of oligonucleotide synthesis, purification, ultrafiltration, conjugation, and lyophilization is preferred.
• Detail-oriented and can perform technical duties following standard operating procedures and general laboratory safety rules.
• Ability to work both independently and in a team setting on a variety of projects and use individual discretion to meet required project objectives and deadlines.
• Excellent math, documentation, communication and operational troubleshooting skills.
• Requires general proficiency with tools, systems and procedures to accomplish job.

Additional Details

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