Role and Responsibilities
- Develop, validate, conduct, and troubleshoot UHPLC and LC-MS analytical methods to quantitate large molecules and metabolites in biological fluids
- Present/interpret data internally and/or externally as needed.
- Participate in interactions with clients and ensure overall customer satisfaction.
- Interacts with QA to ensure all audit findings are addressed in a timely fashion.
- Author and/or review key regulatory documents, laboratory data, and technical reports.
- Assist with the oversight of the laboratory and mentor junior staff.
- Assist in establishing and improving all policies, procedures and required SOP documentation.
- Understand and adhere to corporate standards regarding code of conduct, safety, and GLP/GCP/GDP compliance.
- Ensure and reviews lab maintenance activities and maintains a clean and safe lab environment
- Develop, write, and review protocols and SOPs.
- Participate in regulatory compliance activities
- Perform all other related duties as assigned
Qualifications and Education Requirements
- Ph.D., Master's, or Bachelor's degree in biology, immunology, chemistry, pharmacology, or other related scientific fields required.
- Requires a minimum 0-9 years of relevant experience in a CRO or drug-development environment.
- Ability to work independently and have good attention to details.
- Good knowledge of regulated bioanalysis. GLP/GCLP experience preferred.
- Ability to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients.
- Must be goal-oriented, quality-conscientious, and client-focused.
- Effective written and verbal communication skills.
- Experienced with LCMS or tandem Mass-Spec method development and validation for PK and/or biomarker analysis.
Preferred Skills
- Proficient in MS Office
- Watson LIMS
- Strong knowledge of GLP/GCLP regulations
Salary range is from $105,000 to 120,000
