Duties & Responsibilities:
- Independently designs and performs analytical methods to measure drug formulations by reverse-phase and size exclusion chromatography under Good Laboratory Practices (GLP) guidelines.
- Participate in the development, qualification, and validation of new analytical methods.
- Maintains an organized and detailed notebook according to Good Documentation Practices (GDP) guidelines.
- Reports and treats data with a high level of integrity and ethics. Present results responsibly at team meetings.
- Solid knowledge and understanding of applicable GLP regulations.
- Work in a collaborative manner with members of other departments.
- Review, approve, write, and revise Standard Operating Procedures (SOPs) and Technical Reports.
- Comply with applicable regulation, perform all work in a safe manner; Maintain proper records in accordance with SOPs and polices.
Requirements:
- Knowledge and experience in high performance liquid chromatography (HPLC) method development and validation for drug formulation analysis.
- Experience with HPLC related software, such as Empower, to execute experiments and analyze data.
- Ability to work independently in the lab to prepare reagents, pipette solutions accurately, and operate instruments.
- Prior experience working in a GxP environment is preferred.
- Strong laboratory skills with the ability to resolve and advise on technical issues of a moderate scope and develop new skills through on-the-job experiences.
- Clear and effective written and verbal communication skills.
- Proven problem solving ability.
Education:
- Master s Degree from an accredited institution in a related scientific discipline, OR Bachelor s Degree from an accredited institution with three plus (3+) years of experience in a related scientific discipline or equivalent experience in related field.