Senior Scientist

6 days ago

Columbia, United States EPM Scientific Full time

(Senior) Scientist, Analytical Development

Columbia, South Carolina


Summary:

Seeking a highly experienced (Senior) Scientist to join a global leading Manufacturing Company.


Key Responsibilities:

  • Lead the development, validation, and optimization of analytical methods for small molecule drug products or nutraceuticals.
  • Apply advanced analytical techniques (e.g., HPLC, GC, LC-MS, NMR, etc.) for the characterization, stability, and quality control of small molecules.
  • Collaborate cross-functionally with teams including formulation development, quality assurance, regulatory affairs, and manufacturing to ensure robust analytical support throughout the product lifecycle.
  • Independently design and execute experiments for method development and troubleshooting.
  • Develop strategies to scale up methods from laboratory to clinical and commercial manufacturing.
  • Support regulatory submissions and respond to queries related to analytical testing and method validation.
  • Ensure compliance with cGMP, ICH, and other regulatory guidelines in all analytical work.
  • Mentor and guide junior scientists and staff in the laboratory, offering technical expertise and development opportunities.
  • Prepare technical reports, SOPs, and presentations for internal and external stakeholders.


Qualifications:

  • Ph.D. or Master’s degree (preferred) in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field.
  • 8-10 years of experience in analytical method development, with a focus on small molecule analysis in either pharmaceuticals or nutraceuticals.
  • Expert knowledge of various analytical techniques, including HPLC, GC, LC-MS, NMR, and other modern instrumental methods.
  • In-depth experience with method validation, method transfers, and troubleshooting of complex analytical challenges.
  • Strong knowledge of relevant regulatory guidelines (e.g., ICH, FDA, EMA) and experience with regulatory submissions.
  • Ability to lead projects and work independently with minimal supervision.
  • Excellent problem-solving skills and attention to detail.
  • Strong written and verbal communication skills.

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