Senior Analytical Scientist

We are seeking a highly skilled and dedicated Senior Analytical Scientist to join our industry-leading team. This role is crucial for advancing our scientific capabilities and ensuring the precision and accuracy of our pharmaceutical and nutraceutical validations. As a pivotal part of our company, you will lead the validation of analytical methods, support cross-departmental teams, and carry forward our commitment to quality and regulatory compliance. This position offers the opportunity to work on groundbreaking projects that impact the quality and efficacy of products on a global scale.

Salary: DOE per year

Essential Duties and Responsibilities:

  • Lead the validation of analytical methods for the analysis and prompt release of raw materials, finished products, and stability samples.
  • Design and implement method transfer protocols to enhance the operational efficiency of the QC department.
  • Utilize Empower Software and other relevant laboratory software for chromatographic, spectroscopic, and wet chemical methods.
  • Prepare, review, and approve technical documentation within agreed timelines to support project and regulatory needs.
  • Evaluate testing methodologies across diverse sample matrices and oversee contract laboratory compliance with agreed methods.
  • Keep abreast of technological advancements and integrate latest scientific findings into team practices; mentor colleagues in validation techniques and data interpretation.
  • Participate in routine testing activities as needed to support Quality Control.
  • Collaborate effectively with internal teams and participate in discussions to meet company goals and optimize scientific outcomes.
  • Ensure regular and punctual attendance as a member of the team.

Minimum Position Qualifications:

  • Proficient in laboratory instrument troubleshooting and deep knowledge in the operation of instruments like FTIR, HPLC, GC, UV-Vis.
  • Advanced understanding of analytical chemistry, biochemical processes, and chemical engineering relevant to pharmaceutical and nutraceutical industries.
  • Comprehensive knowledge of statistical analysis, data trend evaluation, and experimental design.
  • Expertise in regulatory compliance, familiar with FDA and ICH guidelines, and experience maintaining GLP/GMP standards in pharmaceutical environments.
  • Dynamic team player capable of working in fast-paced settings and adapt to evolving project demands.

Preferred Qualifications:

  • Master's degree in analytical chemistry, biochemistry, or related field with at least 3 years of technical experience, or Bachelor’s degree with significant experience.
  • Proven capability in high-level method validations and familiarity with international business regulatory requirements.
  • Leadership qualities with the ability to mentor and uplift technical capabilities within teams.

Skills:

  • Advanced proficiency with laboratory software including Empower and familiarity with Chromatographic and Spectroscopic methods.
  • Strong analytical skills with a methodical approach to problem-solving and troubleshooting in laboratory settings.
  • Excellent communication and interpersonal skills to foster cooperation and efficiency across functional units.
  • Detail-oriented with an overarching view on project outcomes and regulatory compliance.
Job Type
Full-Time Regular
Location
Lancaster SC
Industry
Pharmaceutical and Medicine Manufacturing
Max Pay
$0.00