Technical Operations Lead

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