For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

BASIC SUMMARY:

Responsible for the formulation of all products, excipients, and accessories based on production schedules and needs as determined by management to maintain appropriate inventory levels. Ability to develop expertise in LAL product formulation, testing methods, regulatory documentation, SOPs, and associated computer systems and software tools.

JOB QUALIFICATIONS

• Education: Bachelor’s degree (B.A./B.S.) in related discipline.
• Experience:
  o 2-4 years related experience in a laboratory setting using aseptic technique or in the manufacturing of sterile products.
  o Experienced in the use of computer systems, Windows operating system, and Microsoft products

o An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

• Certification/Licensure: none

• Prepare core LAL products, excipients, and accessories using aseptic / sterile technique.
• Considerable scientific skill, attention to detail, concentration, and problem-solving abilities required.
• Maintain currency in all training, SOPs, cGMP, and regulatory requirements.
• Monitor in-process product formulations for quality control, potency, and desired specifications.
• Responsible for process control, batch records, lot number assignment, etc. to ensure compliance with FDA and SOP requirements.
• Responsible for maintaining appropriate laboratory records, data entry, and utilization of all related computer-based systems.
• Responsible for documentation as required by FDA, company policy, and cGMP.
• Participate in investigations as necessary to identify, resolve, and close complex deviations, as well as address corrective or preventive actions.
• Assist in the development of new techniques and methods for enhancing both PTS and core product performance.
• May assist in raw materials selection and vendor selection for materials and equipment used in the formulation or filling of LAL products, excipients, and accessories.
• Assist in preparation for and activities of regulatory driven and/or customer audits.
• May perform seasonal duties associated with processing crude LAL.
• Perform other related duties as assigned