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Analytical Research Scientist II
2 months ago
Position Title: Analytical Research Scientist II
Location: Round Lake, IL
Contract Duration: 12 months
Target Performance Rating: 30-35
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, while also contributing to new product innovations and ongoing product maintenance initiatives. The ideal candidate will:
- Provide substantial technical expertise across various projects within the relevant scientific field with minimal oversight.
- Exhibit a foundational understanding of interconnected scientific disciplines.
- Execute both routine and complex research and design experiments with limited guidance.
It is essential that the candidate is not allergic to Penicillin, Cephalosporin, or any related substances.
Key Responsibilities:
- Perform critical chemical and physical evaluations on stability samples of finished products. Additionally, support testing of raw materials and various product samples from manufacturing or departmental projects with minimal supervision.
- Review test data and ensure adherence to documentation standards. Conduct review functions in Laboratory Information Management Systems (LIMS) or similar computerized platforms.
- Utilize advanced laboratory instruments and software to gather and document data. May be required to oversee system operations or conduct validations.
- Conduct sophisticated chemical assays that necessitate precise analytical skills and a solid grasp of chemical principles. Ensure timely completion of all testing, including special project or protocol assessments, to align with project timelines.
- Maintain data integrity and ensure compliance with company Standard Operating Procedures (SOPs), FDA regulations, cGxP, and Quality System Regulations (QSR).
- Investigate discrepancies and prepare exception documentation.
- Collaborate with various departments to address challenges, enhance efficiency, improve quality, and provide product support.
- Adhere to laboratory safety protocols, perform equipment maintenance and calibration, and troubleshoot basic instrument issues.
Qualifications:
- Strong oral and written communication skills, coupled with robust analytical capabilities and attention to detail.
- Proficient in advanced wet chemistry, volumetric preparation techniques, and instrumental analytical methods.
- Demonstrated ability to train others, exhibit leadership, and foster teamwork and interpersonal relationships.
- Ability to manage multiple tasks concurrently and efficiently.
- Proficient in writing and computer skills.
- Effective communication with managers, peers, and subordinates is essential.
- Ability to interpret data and make informed recommendations to address technical challenges.
Physical Requirements:
- Ability to handwrite and utilize computers for the majority of the workday.
- Capability to transfer materials, mix solutions/products, open containers, and conduct laboratory tests.
- May require prolonged periods of standing.
- Ability to lift up to 10 pounds regularly.
- This position involves exposure to hazards, including chemicals, drug products, and biological agents, including Penicillin and Cephalosporin.
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 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 advantageous.
- Experience in a pharmaceutical GMP laboratory setting is preferred.
- Experience in executing and validating stability studies is desirable.