Charles River Laboratories

Production Chemist

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Job Description

We are seeking a Production Chemist for our Microbial Solutions site located in Charleston, SC.

Responsible for the formulation of all products, excipients, and accessories to maintain appropriate inventory levels.

The following are the job responsibilities related to the Production Chemist:

•    Prepare LAL products, excipients, and accessories using aseptic / sterile technique.  Considerable scientific skill, attention to detail, concentration, and problem solving abilities required.
•    Monitor in-process product formulations for quality control, potency and desired specifications.
•    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.
•    Oversee process control activities (batch records, lot number assignment, etc.) to ensure compliance with FDA and SOP requirements.
•    Responsible for maintaining appropriate laboratory records.
•    Responsible for proficiency in all departmental SOPs.
•    Responsible for documentation as required by FDA, company policy, and cGMP.
•    Perform seasonal duties associated with processing crude LAL.
•    Assist in the development of new techniques and methods for enhancing both PTS and core product performance.
•    Assist in preparation for and activities of regulatory driven and/or customer audits.
•    Lead or participate in investigations are necessary to identify, resolve, and close complex deviations, as well as address corrective or preventive actions.
•    Perform other related duties as assigned.

During Lysate production season (approximately 4 months each year):
•    Perform seasonal duties associated with processing crude LAL.
•    Oversee daily operational activities and supervise a group of non-exempt employees. Ensure optimum group performance.
•    Support the policy of equal employment opportunity through affirmative action in personnel actions.
•    Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and bio-safety protocols].

Job Qualifications
The following are the minimum qualifications related to the Production Chemist:

•    Education:  Bachelor’s degree (B.A./B.S.) in a life science or related discipline.
•    Experience:  3-5 years related experience in a laboratory or aseptic or sterile production / fill operations.
•    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
•    Other:  Considerable scientific skill, attention to detail, concentration, and problem solving abilities required. Must maintain an excellent working knowledge of SOPs and regulations in all areas of responsibility.

Job Summary

Charleston, SC Location
Full Time Job Type
Charles River Laboratories

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