Chemical Analyst

The Chemical Analyst will conduct biological, chemical, and physical analyses on pharmaceutical products (biologics and drugs) and medical devices throughout the manufacturing process, including raw materials, in-process, and finished goods. The role may also involve environmental monitoring to ensure compliance with regulatory standards.

Essential Duties and Responsibilities:

The incumbent will perform other duties as assigned, including but not limited to:

• Perform critical biological, chemical, and physical analyses on raw materials, in-process samples, final products, and environmental monitoring samples.
• Utilize laboratory instrumentation and computer systems (such as LIMS) to collect and record data accurately.
• Conduct assays requiring precise analytical skills and a strong understanding of biological and chemical principles.
• Ensure timely completion of all testing, including special project/protocol testing.
• Maintain data integrity and ensure compliance with company SOPs, FDA, GLP, QSR, and cGMP regulations.
• Write exception documents as required.
• Participate in team efforts aimed at production improvements, efficiency enhancements, problem-solving, cost savings, and quality improvements.
• Conduct laboratory and manufacturing audits and update plant SOPs as required.
• Perform equipment maintenance and calibrations when necessary.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Required Skills & Competencies:

• Ability to manage multiple tasks concurrently and meet deadlines.
• Strong computer literacy and ability to navigate online forms and systems.
• Detail-oriented with high reading comprehension skills.
• Basic understanding of laboratory instrumentation and pharmaceutical production equipment (autoclaves, incubators, process tanks, analytical equipment, CIP/SIP systems).
• Strong verbal and written communication skills in English.
• Familiarity with cGMP manufacturing and regulatory guidelines.
• Ability to work effectively in a team environment with good interpersonal skills.
• Knowledge of basic laboratory safety procedures for chemical and biological materials.

Personal Attributes:

• Integrity, trust, and strong work ethic.
• Intellectual honesty and sound judgment.
• Passion for innovation and drive for solutions.
• Commitment to quality and continuous improvement.
• Accountability for results and integrity in decision-making.

Education & Experience:

• Bachelor's degree in Chemistry or Biological Sciences with Analytical Chemistry or Laboratory coursework.
• 0-2 years of relevant laboratory experience.
• Additional certifications may be required based on state or federal regulatory requirements.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.