Technical Operations Lead

Req ID #:  222347
Location: 

US

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

 

Charles River Labs located in is seeking a Technical Operations Lead on our Rightsource Solutions team. 

This position is a remote work role that will cover a large growing operations territory from Oklahoma to the UK. 

 
This role will be responsible for supporting RightSource Solutions (RS) Technical Operations. Namely, the coordination of all operational support activities, including technical writing, qualification/validation, method/equipment lifecycle, training, IT, EHS&S, CSV Operations.  Support a scalable and digital operating model that can be used to grow the RightSource business and act as a testing ground for the broader Biologics Division.

 

Job Responsibilities  


•    Establish and maintain the strategy for GMP activities within the RightSource group.
•    Author, review, and approve GMP technical documentation for the RightSource group and advise\mentor the group on best practices.
•    Manage GMP operational workflows at the site or business level.
•    Lead qualification/validation strategy and execution for both equipment and methods.
•    Contribute to an operating model for all contracts and sites within RightSource group that allows for a smooth transition to business as usual without frequent intervention.
•    Support the establishment of a paperless digital platform that all RightSource sites will use for their operations. 
•    Establish and maintain operating principles that consider full lab, equipment, validation, and staffing impacts to lifecycle management and the scalability of operations. 
•    Support a broad depth of technical expertise within the RightSource teams to be able to provide broad remote and onsite coverage to varying client needs leveraging the RS digital platform to do so.
•    Contribute to the playbook for how to setup future GMP RightSource QC labs based on lessons learned from the initial deployments.
•    Promote a ‘right first time’ documentation and review culture across the RightSource group.
•    Foster effective communication between departments, site(s) and the QA group.
•    Identify problems and propose effective solutions for resolving operational issues.
•    Oversee the development, implementation, and management of programs that will ensure efficiency and will maximize all applicable resources.
•    Promote the alignment of practices across the RightSource group and apply a holistic and scalable approach.  
•    Provide technical support and information to the Commercial function for new business opportunities and on-going contracts.
•    Motivate and support RightSource personnel to execute work in accordance with best practices, in order to meet client expectations and to increase performance and productivity.

 

Job Qualifications


•    Education: Advanced degree (Master’s Degree, M.B.A, and/or Ph.D.) in scientific discipline.
•    Experience:  6 or more years related technical experience in research or pharmaceutical environment.
•    Must have a background in cGMP operations required.
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Other:  Excellent communication (both written and verbal), customer service and negotiation skills.  

• Ability to interact appropriately with all levels of employees, while at the same time support the efforts of departmental teams.

• Ability to perform independently with a minimum of direct supervision and demonstrate sound professional judgment and positive, professional leadership skills.

•This role will require you to work Global hours to support business needs from Oklahoma to the UK up to and including early morning hours to late night hours . 

 

Compensation Data

 The pay range for this position is  $105,000 - $115,000 USD annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.

Competencies

About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

 

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 over 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. 

 

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 86% of the drugs approved by the FDA in 2021.

 

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.

 

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 [email protected]. 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.


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