Senior QC Chemistry Analyst

2 weeks ago

Holly Springs, United States FUJIFILM Corporation Full time

Position Overview:

Discover Your Potential at FUJIFILM Corporation

At FUJIFILM, we are committed to making a significant impact in the life sciences sector. Our expansive growth and investment in state-of-the-art facilities are designed to enhance our capabilities in biopharmaceutical manufacturing. We are seeking dedicated professionals who are eager to contribute to groundbreaking advancements in healthcare.

About the Role:

The Senior QC Chemistry Analyst operates with a degree of autonomy to implement quality control analytical chemistry techniques essential for the production of biological products. This includes a variety of methodologies such as chromatography, spectroscopy, electrophoresis, and other analytical assessments. The role demands adherence to Good Manufacturing Practices (GMP) and regulatory standards to ensure the integrity of laboratory operations.

Key Responsibilities:

  • Conducts comprehensive physical and chemical analyses of biological products utilizing techniques such as GC, HPLC, UPLC, and various spectroscopic methods.
  • Ensures compliance with GMP regulations during the testing of in-process materials, drug substances, and stability samples.
  • Maintains data integrity by accurately capturing analytical results in Laboratory Information Management Systems (LIMS).
  • Identifies and addresses any deviations or anomalies in assay performance, initiating corrective and preventative actions as necessary.
  • Facilitates training and mentorship for junior QC Chemistry staff.
  • Collaborates with cross-functional teams to meet organizational objectives and enhance laboratory efficiency.
  • Authors and reviews standard operating procedures (SOPs) and technical documentation.

Qualifications:

Minimum Requirements:

  • Bachelor's degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or a related field with a minimum of three years of relevant experience.
  • Demonstrated laboratory experience, including at least one to three years in a GMP environment.
  • Proficiency in various analytical testing methods applicable to biological product manufacturing.

Preferred Qualifications:

  • Master's degree in a relevant scientific discipline with at least one year of experience.
  • Familiarity with raw material methodologies in a cGMP context.
  • Experience with LIMS software is advantageous.

Work Environment:

The role requires the ability to perform tasks that involve prolonged periods of standing or sitting, as well as the capacity to handle light physical activities. The working environment may vary in temperature and space constraints.

FUJIFILM Corporation is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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