Senior Scientist

(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.