Research Associate, Process Development

Agilent Technologies•Boulder, CO

1d•Onsite

About The Position

The candidate will be responsible for process chemistry and development activities that delivers milligram to gram quantities of active pharmaceutical ingredients (API) for oligonucleotide therapeutics. This includes assisting in developing synthetic routes, methods, and techniques in preparing, separating, purifying, analyzing, quantifying, and resolving oligonucleotide process components and objectives. Essential duties and responsibilities include but are not limited to : Studying and implementing oligonucleotide project objectives and targets related to engineering and chemical requirements to better understand requirements. Additionally, they will be encouraged to study emerging trends in oligonucleotide analytical methods and synthesis development, review professional and technical publications, establish personal networks, and benchmark state-of-the-art practices. Execute process development experiments and activities. Documents analyses by completing experiment notebooks and records; implementing process chemistry applications and analyzing results of new oligonucleotide synthesis and purification methods and processes. This includes preparing process descriptions and writing technical reports to support internal technology transfer into manufacturing and preparation of client CMC submissions. 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 while adhering to standard operating procedures (SOP's) and current good manufacturing practices to maintain compliance integrity (cGMP). 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.

Requirements

Bachelors, Masters, or University Degree in chemistry, chemical engineering, or science.
Equivalent or a combination of education and a minimum of 2 years of experience in a pharmaceutical environment.
Ability to work both independently and in a team setting on a variety of projects.
Ability to use individual discretion to meet required time-sensitive objectives for assigned projects.
Excellent math, documentation, communication and operational troubleshooting skills.
General proficiency with tools, systems, and procedures required to accomplish the job.
Knowledge of and skill in using computer software and hardware applications, including Microsoft products and the Internet.

Nice To Haves

Proven knowledge of oligonucleotide synthesis, purification, ultrafiltration, conjugation, and lyophilization is advantageous.

Responsibilities

Process chemistry and development activities for oligonucleotide therapeutics.
Assisting in developing synthetic routes, methods, and techniques for preparing, separating, purifying, analyzing, quantifying, and resolving oligonucleotide process components.
Studying and implementing oligonucleotide project objectives and targets related to engineering and chemical requirements.
Studying emerging trends in oligonucleotide analytical methods and synthesis development.
Reviewing professional and technical publications, establishing personal networks, and benchmarking state-of-the-art practices.
Executing process development experiments and activities.
Documenting analyses by completing experiment notebooks and records.
Implementing process chemistry applications and analyzing results of new oligonucleotide synthesis and purification methods and processes.
Preparing process descriptions and writing technical reports to support internal technology transfer into manufacturing and preparation of client CMC submissions.
Applying laboratory experience in chemistry and separations to process optimization, scale-up, and laboratory process transfer to mid and kilo scale GMP manufacturing.
Adhering to standard operating procedures (SOP's) and current good manufacturing practices (cGMP).
Executing Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments to support design space understanding and process validation.