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Analytical Scientist I
2 months ago
Location: Raleigh/Durham, North Carolina
Company: SmaBio Labs
About Us: SmaBio Labs is a premier pharmaceutical organization committed to enhancing health and wellness through cutting-edge research and development. Our team prioritizes excellence and scientific integrity, delivering high-quality services to facilitate drug development and manufacturing.
Position Overview: We are looking for a dedicated and skilled Analytical Scientist I to contribute to our mission. The successful candidate will possess a robust background in analytical chemistry, particularly in pharmaceutical contexts. This position entails the development and validation of analytical methodologies, performing both quantitative and qualitative analyses, and ensuring adherence to regulatory standards.
Key Responsibilities:
- Design, validate, and refine analytical methods for pharmaceutical substances and products.
- Execute intricate quantitative and qualitative analyses utilizing techniques such as HPLC, GC, MS, and spectroscopy.
- Conduct evaluations of both sterile and non-sterile pharmaceutical products.
- Analyze and interpret analytical data, prepare comprehensive reports, and communicate findings to relevant stakeholders.
- Ensure compliance with regulatory guidelines and standards, including FDA and ICH requirements.
- Diagnose and resolve issues related to analytical instruments and methodologies.
- Collaborate with cross-functional teams, including R&D, quality control, and manufacturing, to support product development and troubleshooting efforts.
- Maintain laboratory equipment, ensuring proper calibration and upkeep.
- Stay informed about industry trends, emerging technologies, and best practices in analytical chemistry.
Qualifications:
- Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related discipline.
- 2 - 5 years of experience in analytical chemistry, ideally within the pharmaceutical or biotechnology sectors.
- Experience in method development and validation for pharmaceutical products.
- Proficiency in operating analytical instruments such as HPLC, GC, MS, and UV-Vis spectrophotometers.
- Strong understanding of regulatory requirements and good laboratory practices (GLP).
- Familiarity with quality management systems and documentation practices.
- Experience in testing sterile and non-sterile pharmaceutical products.
- Excellent problem-solving abilities and capacity to analyze complex data sets.
- Adherence to lab safety and environmental health and safety protocols.
- Strong written and verbal communication skills, with the ability to present technical information clearly.
- Ability to work independently as well as collaboratively in a fast-paced environment.
Preferred Skills:
- Advanced degree or certification in analytical chemistry is advantageous.
- Familiarity with MS Office Suite, LabSolutions, OpenLab, ChemDraw, EndNote.
What We Offer:
- Competitive salary and benefits package.
- Opportunities for professional growth and career advancement.
- A collaborative and dynamic work environment.
