Analytical Chemist

Blue Signal
Huntersville, NC
Full-time

Our client is a large-scale manufacturing company that works with Fortune 500 companies and household brands to develop winning products.

They’re seeking an Analytical Chemist to join their dynamic team.

The Analytical Chemist plays a crucial role in the development and validation of analytical methods, specification establishment, and pharmaceutical product testing.

This role demands a blend of creativity, analytical expertise, and collaborative spirit to ensure the success of projects within a regulated manufacturing environment.

This Role Offers :

  • Competitive salary package, inclusive of bonuses, comprehensive benefits (medical / dental / vision), 401(K) match, and more.
  • A culture characterized by high employee retention and minimal bureaucratic hurdles.
  • Stable financial positioning, with the company holding a significant market share.
  • A commitment to innovation, with dedicated operations for new product development and support for existing brands.
  • Unparalleled autonomy, allowing you to shape your career trajectory.

Focus :

  • Collaborate with Innovation, Production, and Marketing departments to lead project development, ensuring timely deliverables.
  • Conduct second reviews of analytical results and provide feedback as necessary.
  • Perform instrument troubleshooting, preventive maintenance, and operational qualification of laboratory equipment.
  • Lead analytical tasks associated with product development and communicate progress to relevant departments.
  • Draft specifications and standard operating procedures (SOPs) and generate protocols and reports.
  • Facilitate training sessions for laboratory analysts during method transfer.
  • Maintain a clean and organized laboratory environment to ensure compliance with regulatory standards.
  • Actively participate in cross-departmental meetings and contribute insights as required.
  • Review laboratory notebooks, provide constructive feedback, and ensure compliance with internal protocols.
  • Design method validation protocols and execute validation experiments for drug substances and dosage forms.
  • Analyze data, draw conclusions, and make recommendations based on experimental findings.
  • Participate in evaluating innovation capabilities and identifying opportunities for new product ideas.

Skill Set :

  • Bachelor’s, Master’s or PhD degree in Chemistry or a relevant science discipline.
  • Minimum of 5 years’ experience in a regulated manufacturing environment.
  • Experience in dissolution, drug impurity method development, and / or method validation preferred.
  • Knowledge of ICH guidelines for drug product analysis and familiarity with analytical data regulatory submission requirements and quality by design principles preferred.
  • Proficiency in chromatography techniques, including gas chromatography (GC) and high-performance liquid chromatography (HPLC).
  • Strong understanding of cGMPs and GLPs, with familiarity in solid analytical techniques.
  • Demonstrated ability to work independently and within a team environment with excellent written and verbal communication skills.
  • Exceptional creativity, innovation, and decision-making skills.
  • Proficiency in Microsoft Office suite and relevant software applications.
  • Flexibility to work flexible hours when necessary.
  • 30+ days ago
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