Down Stream Viral Vector, Senior Scientist- Process Development

Req ID #:  215678
Location: 

Rockville, MD, US, 20850 Rockville, MD, US, 20850

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.

 

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   
 

Job Summary

 

Our Cell & Gene Therapy ( Viral Vector) Team has a unique opportunity located in Rockville, MD for a  Down Stream Senior Scientist, Process Development.

This role is located in Rockville, MD and is needed onsite. 


 

We are seeking a Senior (Sr.) Scientist Process Development to independently design and execute process development studies and experiments, and to record, analyze, and present data to relevant stakeholders. 

 


 Roles and Responsibilities: 

 

•    Design and execute experiments to support process development, including gene therapy process optimization, technology development, and process modelling.
•    Steer process development strategy.
•    Perform analytical testing to characterize biological processes.
•    Perform and lead technical transfer activities and manufacturing support for the clinical/commercial process.
•    Make detailed observations, analyze data, interpret results, and convey these findings effectively in laboratory documents, technical reports, and presentations.
•    Participate in various cross-functional teams and demonstrate a strong ability to collaborate and communicate with others.
•    Present at internal departmental and cross-functional meetings; may participate in/present at external scientific meetings with a client-facing role.
•    Contribute to and author process development and tech transfer reports, and possibly also scientific publications, patents, and regulatory submissions.
•    Train and mentor more junior team members and lead smaller study teams as needed. 
•    Perform other duties as assigned. 

Job Qualifications

 

 

Education:  

 

Bachelor’s degree with 10+ years experience, Master’s degree with 8+ years experience, or PhD with 6+ years experience.

 

Experience:     

 

      •    Previous experience in biopharmaceutical, bioprocessing, analytical, and/or drug product or process development required.
        •    Prior experience with relevant small to large scale bioprocessing equipment required.
        •    Prior experience with relevant processes as they pertain to gene therapy required.
        •    Prior experience working in CDMO or CRO industry required.
        •    Prior experience in a client-facing role required.

 

Skills & Abilities: 

 

             •    Ability to present at internal departmental and cross-functional meetings and the expectation. 
            •    Contribute to and/or authoring technical reports, and possibly also scientific publications, patent applications, and regulatory submissions.
            •    Make detailed observations, analyze data, interpret results, and contribute to important decisions based on data.
            •    Ability to work and perform studies independently while also being able to work collectively in a larger team and organizational environment. 
            •    Train and mentor more junior process development team members and lead smaller study teams as needed.
            •    Ability to participate in client-facing discussions.

 

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

 
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 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.


Nearest Major Market: Washington DC

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