PTS, LAL/TAL Production - Associate

PTS, LAL/TAL Production - Associate Req ID #:  139328 Location: 

Charleston, SC, US, 29407 For 70 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. Job Summary 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.

About Microbial Solutions

Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 17,000 employees within 90 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

Nearest Major Market: Charleston South Carolina

Nearest Secondary Market: South Carolina

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