Job Category: Clinical: Scientific
Job Number: 2685
The Analytical Research Associate II assists in the execution of analytical and characterization methods to support pharmaceutical formulation, process, and method development activities. This person will work with other members of the team in implementing analytical methods for therapeutic proteins, peptides and small molecule drug formulations targeting human disorders, including diabetes and epilepsy. This role will also support Quality Control and CMC with respect to establishing methods requiring transfer to contract labs, material qualification, method validations, and process validation support.
- Keeping the laboratory clean, organized and ensuring all the instruments are calibrated and functioning properly.
- Participating in laboratory meetings and planning sessions.
- Read literature applicable to research areas as required.
- Assist in the execution of analytical methods (KF, UV/Vis, HPLC, LC/MS etc.) for use in analytical testing and characterizing prototype pharmaceutical formulations.
- Read and interpret compendial monographs and procedures (USP, EU, etc.).
- Maintaining inventory of chemicals, reagents, and other laboratory supplies.
- Direct interaction with equipment/supply vendors and customer service agents.
- Perform the duties as required to support reference standard programs, instrument maintenance/calibration, method development, optimization, transfer, and stability studies.
- Configure and operate laboratory instruments, including HPLC, Karl Fischer Titrator, etc.
- Read and record instrument data, tabulate data, and keep detailed laboratory records.
- Draft Standard Operating Procedures (SOPs) for laboratory equipment and instrumentation.
- BS degree in biology, biochemistry, chemistry or related discipline with 2 to 5 years of relevant pharmaceutical industrial experience or MS degree in similar disciplines with 0-2 years of relevant pharmaceutical industrial experiences.
- Ability to learn complex tasks with general instructions and perform them independently and reliably.
- Ability to work independently as well as in a team.
- Self-starter, resourceful, flexible, responsive, detail oriented and possess a good work ethic.
- Must possess excellent written and verbal communication skills.
- Ability to draft routine reports and maintain accurate and detailed records of work performed.
- Previous experience in a quality control or other regulated testing laboratory a plus.
- Must be able to stand for extended periods of time.
- Must be able to lift 25 lbs. or more.
- Adequate vision (corrected or uncorrected) to read fine instruments such as caliper, instrument displays etc. and perform visual inspection for defects.
- Working knowledge of Microsoft Productivity software (Excel, Word etc.).
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