Lead Analytical Chemist

2 weeks ago

Irvine, California, United States LGM Pharma, LLC Full time
Position Overview

We are seeking a qualified Senior Quality Control Chemist to join our Quality Control Department. This role is essential in ensuring the integrity and quality of our products through rigorous testing and validation processes.

Key Responsibilities:

  • Conduct method validation, verification, and transfer for analytical testing of clinical submission materials, including raw materials and finished products.
  • Oversee the maintenance and troubleshooting of analytical instrumentation.
  • Document and perform laboratory investigations as required.
  • Review and validate data produced by fellow chemists and technicians.
  • Develop, validate, and troubleshoot analytical methodologies.
  • Facilitate method transfers from various facilities and departments.
  • Draft and maintain standard operating procedures and analytical methods.
  • Assist with equipment calibrations and qualifications.
  • Support laboratory management in training new employees.
  • Contribute to preparations for internal, customer, and regulatory audits.
  • Perform additional related duties as assigned.

Qualifications:

  • Bachelor's degree in Chemistry or a related field.
  • A minimum of 5 years of experience in a chemistry laboratory or a comparable combination of education and experience.
  • Extensive experience (5+ years) with analytical instruments such as HPLC, GC, CE, ICP, FTIR, and dissolution apparatus.
  • At least 2 years of experience in a GLP or GMP environment is preferred.
  • Proficient in following standard operating procedures.
  • Excellent written and verbal communication skills.
  • Strong organizational skills with the ability to prioritize and manage multiple tasks independently.
  • Meticulous attention to detail.

Employment Type: Full-Time

At LGM Pharma, we are committed to fostering a diverse and inclusive workplace. We are an equal opportunity employer, and all qualified candidates will be considered for employment based on objective work-related criteria without regard to age, disability, ethnic origin, gender, marital status, race, religion, sexual orientation, or gender identity, in accordance with applicable laws.

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