EPM Scientific | Senior Scientist | columbia, mo
5 days ago
(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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columbia, United States EPM Scientific Full time(Senior) Scientist, Analytical DevelopmentColumbia, South CarolinaSummary: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.,...
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