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Technical Operations Lead

4 months ago

Wilmington, United States Charles River Laboratories Full time

**Req ID #**:222347**Location**:Wilmington, MA, US, 01887
- 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 Wilmington, MA is seeking a Technical Operations Lead on our Rightsource Solutions team.**

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.

**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.
- 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.

**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 suppor