Research Associate, Analytical Development
San Diego, CA
The research associate position will primarily focus on performing routine analysis in support of release and stability of API and finished drug product. In addition, the candidate will perform analysis to support formulation and process development and assist senior staff to develop and qualify new testing methods.
The candidate will also work with our internal Quality Assurance team, to ensure that high quality standards are maintained and appropriate documentation such as laboratory notebook, controlled form, logbook, protocol and reports are completed in a timely manner and that standard operating procedures (SOP’s) are followed as written.
The ideal candidate will have shown proficiency in operation of various analytical instruments (HPLC, pH, osmometer, KF, disintegration, gel electrophoresis, spectroscopy, etc.) and the ability to troubleshoot instrument error.
- Comply with all safety rules, practice good housekeeping, and maintain safe workplace with minimal supervision.
- Assist in maintaining inventories of chemicals, reagents, and reference materials.
- Independently perform in-process, release, and stability testing following approved test methods and SOPs.
- Review analytical data summaries to support batch release and stability assessments for clinical material.
- Conduct and document analytical investigations following SOPs and regulatory guidelines; initiate and close deviations, CAPAs, and change request.
- Maintain accurate and complete laboratory notebooks, forms, and logs/logbooks in a timely manner.
- Perform routine maintenance and calibration of laboratory equipment and instrumentation.
- Maintain training record per GXP and company training requirements.
- Develop, qualify, validate, and transfer analytical test methods for testing drug substance and drug product with guidance from AD management.
- Present data to communicate findings to internal groups and management.
- A minimum of a BA/BS degree in chemistry, biochemistry, or related field.
- Associate level opportunity for recent graduates and entry level candidates with less than 2 years of related experience.
Technical Skills and Knowledge
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- Follow instruction to perform required procedures
- Detail-oriented, with excellent organizational and record-keeping skills
- Critical thinking, scientific reasoning and problem solving skills
- Basic computer skills, including MS Office
- Strong work ethic with ability to work on multiple tasks with efficient approach to complete the work on time with high accuracy
- Excellent communication skills; able to work in a team-oriented environment.
- Effectively collaborate across cross functional teams
- Good time management skill to work on multiple projects within deadlines
- Ability to effectively prioritize workload and manage changes in priorities