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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 pioneering research and development. Our team prioritizes excellence and scientific integrity, delivering top-notch services to facilitate drug development and manufacturing.
Position Overview: We are in search of a proficient and enthusiastic Analytical Scientist I to contribute to our mission. The successful candidate will possess a robust foundation in analytical chemistry, particularly in pharmaceutical contexts. This position entails the development and validation of analytical methodologies, executing both quantitative and qualitative analyses, and ensuring adherence to regulatory standards.
Key Responsibilities:
- Design, validate, and refine analytical methods for drug substances and formulations.
- Conduct intricate quantitative and qualitative analyses utilizing techniques such as HPLC, GC, MS, and spectroscopy.
- Perform testing on both sterile and non-sterile pharmaceutical products.
- Interpret and evaluate analytical data, generate comprehensive reports, and communicate findings to relevant stakeholders.
- Ensure adherence to regulatory guidelines and standards, including FDA and ICH protocols.
- Diagnose and resolve challenges related to analytical instruments and methodologies.
- Collaborate with interdisciplinary teams including R&D, quality assurance, and manufacturing to aid in product development and troubleshooting.
- Maintain laboratory instruments and ensure proper calibration and upkeep.
- Stay informed about industry advancements, 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.
- Proficient 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 standards.
- Experience in testing sterile and non-sterile pharmaceutical products.
- Excellent analytical skills and the capability to interpret complex data sets.
- Adherence to laboratory safety and environmental health and safety protocols.
- Strong written and verbal communication skills, with the ability to convey technical information effectively.
- Ability to work autonomously 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 comprehensive benefits package.
- Opportunities for professional growth and career progression.
- A collaborative and dynamic workplace environment.
