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Scientific Research Associate II
2 months ago
Position Overview:
This role is pivotal in conducting analytical evaluations, validation, and transfer of testing methodologies that support pharmaceutical parenteral products. The primary focus will be on stability assessments, with additional responsibilities in new product development and sustaining product initiatives.
Key Responsibilities:
- Execute critical chemical and physical analyses on stability samples of finished products, while also supporting the testing of raw materials and various product samples.
- Review test data meticulously, ensuring compliance with documentation standards and utilizing systems such as LIMS.
- Employ advanced laboratory instruments and computerized systems for data collection and recording, potentially taking on system ownership or validation tasks.
- Conduct sophisticated chemical assays that require precise analytical skills and a solid understanding of chemistry principles, ensuring timely completion of all testing activities.
- Uphold data integrity and adhere to company SOPs, FDA regulations, cGxP, and QSR standards.
- Investigate deviations and prepare exception documentation as necessary.
- Collaborate with cross-functional teams to enhance efficiency, quality, and product support.
- Maintain laboratory safety protocols, perform equipment maintenance and calibration, and troubleshoot basic instrument issues.
Qualifications:
- Strong oral and written communication skills, along with robust analytical capabilities and attention to detail.
- Proficiency in advanced wet chemistry, volumetric preparation techniques, and instrumental analysis methods.
- Demonstrated ability to train others and exhibit leadership, organizational skills, teamwork, and results-oriented task completion.
- Ability to manage multiple tasks concurrently and efficiently.
- Competence in writing and computer skills is essential.
- Effective communication with managers, peers, and subordinates is crucial.
- Ability to interpret information and provide recommendations to address technical challenges.
Physical Requirements:
- Capability to handwrite and utilize computers for the majority of the workday.
- Ability to transfer materials, mix solutions, open products, and conduct laboratory testing.
- Potential requirement to stand for extended periods.
- Ability to lift up to 10 pounds regularly.
- This position may involve exposure to hazardous materials, including chemicals and biological agents.
Education and Experience:
- Bachelor's degree in a relevant scientific field (e.g., chemistry, pharmaceutical sciences) with analytical chemistry laboratory coursework and a minimum of 2 years of experience.
- Experience with analytical chemistry instrumentation (e.g., HPLC, UPLC, UHPLC, pH, KF, titration).
- HPLC experience is mandatory; familiarity with Empower software is preferred.
- Experience with Electronic Lab Notebooks is desirable.
- Prior experience in a pharmaceutical GMP laboratory is preferred.
- Experience in executing stability studies and validation processes is advantageous.
