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.
Job Summary
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· 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
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
PHYSICAL DEMANDS:
· While performing the duties of this job, the employee is regularly required to use hands to handle, finger or feel objects, tools, or controls; stand, walk and bend; and is occasionally required to lift 55-75 pounds and decant into another container.
· Specific vision abilities required by this job include close vision and the ability to adjust focus.
· Employee must frequently lift and/ or move up to 50 pounds.
WORK ENVIRONMENT:
· Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
· Regularly provides information to and receives information from/through various technologies, media, sources, and contacts. Must be able to accurately exchange accurate information in these situations.
· While performing the duties of this job, the employee frequently wears protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, and boots).
· The employee occasionally works near moving mechanical parts; works with sharp objects; works with or near toxic or caustic chemicals and biohazards; and works with live animals (small, medium, large) with risk of exposure to allergens.
Compensation Data
The pay range for this position is $57,500 to $67,600. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.
Competencies
Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.
Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.
Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.
Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.
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 20,000 employees within 110 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 80% of the drugs approved by the FDA in the last five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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, a member of our Human Resources team by sending an ssage to crrecruitment_UScrl. 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, criver.
