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Analytical Research Specialist II
2 months ago
Position Overview:
This role is crucial for conducting analytical evaluations, validation processes, and method transfers that support the development of pharmaceutical parenteral products. The primary focus will be on stability assessments, while also contributing to new product initiatives and ongoing product support.
Key Responsibilities:
- Execute essential chemical and physical analyses on stability samples of finished products. Additionally, support the evaluation of raw materials and various product samples throughout the manufacturing process.
- Review test data meticulously, ensuring adherence to documentation standards and practices within laboratory information management systems (LIMS) or similar computerized platforms.
- Utilize advanced laboratory instruments and software to gather and document data accurately. Responsibilities may include system ownership or validation tasks.
- Conduct sophisticated chemical assays that demand high-level analytical expertise and a solid grasp of chemical principles. Ensure timely completion of all testing, including special projects.
- Uphold data integrity and compliance with company standard operating procedures (SOPs), as well as regulatory requirements including FDA, cGxP, and QSR.
- Investigate any deviations and prepare exception documentation as necessary.
- Collaborate with cross-functional teams to enhance problem-solving, efficiency, and product quality.
- Maintain safety protocols in the laboratory, perform routine equipment maintenance and calibration, and address basic instrument issues.
Qualifications:
- Strong oral and written communication skills, along with exceptional analytical abilities and attention to detail.
- Proficiency in advanced wet chemistry, volumetric preparation techniques, and instrumental analysis methods.
- Demonstrated capability in training peers, exhibiting leadership, organizational skills, teamwork, and a results-oriented approach.
- Able to manage multiple tasks effectively and efficiently.
- Competent in both writing and computer skills.
- Ability to communicate technical information clearly to managers, colleagues, and subordinates.
- Skilled in interpreting data and providing recommendations to address technical challenges.
Physical Requirements:
- Capable of handwriting and utilizing computers for extended periods.
- Able to handle materials, mix solutions, and conduct laboratory tests.
- May require prolonged standing.
- Must be able to lift up to 10 pounds regularly.
- This position involves exposure to various hazards, including chemicals and biological materials.
Education and Experience:
- Bachelor's degree in a relevant scientific field (e.g., chemistry, pharmaceutical sciences) with coursework in analytical chemistry and a minimum of two years of experience.
- Experience with analytical chemistry instrumentation (e.g., HPLC, UPLC, UHPLC, pH, KF, titration).
- HPLC experience is essential; familiarity with Empower software is preferred.
- Experience with electronic lab notebooks is advantageous.
- Prior experience in a pharmaceutical GMP laboratory is preferred.
- Experience in executing and validating stability studies is a plus.
