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, well help you build a career that you can feel passionate about.
BASIC SUMMARY:
Perform a wide variety of technical procedures during the course of animal safety studies. The Tech Level IV is assigned to studies of varying complexity and exercises judgment within defined Standard Operating Procedures and practices to determine appropriate action.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Perform daily test article preparation and recording of data for contracted laboratory studies.
- Prepare labels and samples.
- Record study parameters as required by protocol.
- Ensure adequate supply of formulations equipment during the course of study.
- Provide technical guidance and assist with other Formulations personnel in preparation of test articles. Prepare packing lists for shipment of samples to Sponsors and/or Archives.
- Ensure raw data records are accurate, complete, paginated and in appropriate order, and meet protocol and SOP specifications and GLP requirements.
- Prepare sample storage packing lists and ensure reserve samples and sample packing lists are accurate and complete (sample inventory).
- May assist in training laboratory personnel in basic laboratory techniques.
- Interact with Study Directors, Study Coordinators, Data Management, Animal Care and technical staff in planning and conduct of studies.
- Assist Study Directors and Study Coordinators in preparing responses to both internal and Sponsor quality Assurance Audits.
- Draft preparation procedures.
- Generate test article requirements.
- Ensure that technicians assigned to studies understand what needs to be completed and that all assignments are covered.
- Ensure that weekend laboratory assignments have been made and that the technicians assigned understand what needs to be completed and that all assignments are covered.
- Confirm that the Formulations Laboratory is aware of study specific requirements.
- Ensure that the all laboratory areas are aware of special study specific requirements. See data sheet.
- Ensure that shipment of study samples are collected, packed and shipped properly and on time.
- Assist with facility security and emergency procedures such as setting alarms, opening or closing the building, resetting printers.
- To review draft copies of protocols for omissions and other needed items.
- Perform other duties as assigned by supervisor.
QUALIFICATIONS:
- Education: Bachelors degree (B.S.) or equivalent.
- Experience: Minimum of 2 to 4 years experience in a GLP Formulations Laboratory.
- 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: Must successfully complete the Core Competency Matrix for Formulation Laboratory Technician III.
PHYSICAL DEMANDS:
- While performing the duties of this job, the employee is regularly required to talk, hear and lift.
- Must be able to regularly wear safety equipment and clothing in compliance with OSHA regulations and company SOPs.
- Specific vision abilities required by this job include the regular use of close vision and the ability to adjust focus.
- Must be able to regularly measure and combine chemicals in order to prepare test article for use in the laboratory.
- Regularly record data by hand or on a computer terminal.
- Regularly stand approximately 4 to 6 hours a day.
- Must be able to occasionally lift and manipulate up to 50 pounds.
- Must be able to occasionally manipulate and remove objects from shelves one and one half to six and one half feet above the floor (with the aid of a step stool).
WORK ENVIRONMENT:
- General research laboratory working conditions.
- The noise level in the work environment is usually moderate.
- Works with or near caustic chemicals and with chemical compounds with unknown levels of toxicity.
- This position requires a work day that typically begins at one-half hour to an hour earlier than scheduled start times main study lab. Must be available to work Saturdays, Sundays, and all holidays on a rotating basis.
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
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 14,000 employees within 80 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.
At Charles River, we are passionate about our role in improving the quality of peoples 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 2018.
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.