Analytical Scientist

2 weeks ago

Gaithersburg, Maryland, United States Kaztronix Full time

Kaztronix is seeking a highly motivated and experienced Analytical Scientist to join our growing Quality Control team in Gaithersburg, MD.

In this role, you will play a crucial part in ensuring the quality and integrity of our products by providing technical expertise across various analytical processes.

Responsibilities:
  • Contribute to the development and implementation of robust Quality Control analytical lifecycle management programs.
  • Lead method transfers and validations, ensuring adherence to established protocols and regulatory guidelines.
  • Collaborate with Analytical Development teams on the introduction of new technologies and instrumentation, driving innovation within the QC environment.
  • Proactively troubleshoot and investigate analytical method performance trends, identifying root causes and implementing corrective actions.
  • Provide expert technical support for manufacturing deviations and out-of-specification (OOS) investigations, working closely with Manufacturing and Quality Assurance teams.
  • Serve as a key liaison between Quality Control and Analytical Development, fostering seamless communication and collaboration.
  • Contribute to cross-functional teams focused on resolving complex product and analytical challenges.
  • Author comprehensive documentation for deviations, investigations, and method transfer/validation reports.
  • Collaborate with development and manufacturing colleagues to implement robust analytical controls, ensuring the highest quality standards throughout the production process.
  • Prepare analytical source documentation for regulatory submissions (IND/BLA), demonstrating a deep understanding of CMC requirements and regulatory expectations.
  • Build and maintain strong relationships with internal stakeholders across Research & Development, Regulatory CMC, Quality, and external partners.
Qualifications:
  • Bachelor's degree in Biochemistry, Chemistry, or a related scientific discipline.
  • Minimum of 6 years of experience in the biopharmaceutical industry, with a proven track record in analytical method development and validation.
  • Strong scientific knowledge and practical experience in analytical methodologies used for large molecules.
  • Comprehensive understanding of global drug development regulations and current expectations (e.g., cGMPs/GLPs, ICH, FDA CMC Guidance Documents).
  • Experience with preparing CMC technical sections for regulatory submissions and effectively communicating with regulatory authorities.
  • Exceptional analytical and problem-solving skills, coupled with a collaborative and solution-oriented approach.
  • Excellent communication and interpersonal skills, both written and verbal.

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