Manager, GMP Manufacturing

Req ID #:  143471
Location: 

Rockville, MD, US, 20850 Rockville, MD, US, 20850 Rockville, MD, US, 20852

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, 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

 

The Manager, GMP Manufacturing leads the manufacturing team through production campaigns, owning the production suites, and being accountable for schedule adherence. This individual is passionate about: building a continuous learning environment within manufacturing and with department colleagues in development and technical transfer and support, sharing of best practices and learning opportunities, and building robust readiness and execution processes to drive sustainable right-first-time performance.


DUTIES AND RESPONSIBILITIES


•    Provide a service-oriented and results mindset to delight both internal and external customers.
•    Create a new department from the ground-up to support a high velocity organization.
•    Ensure safety of manufacturing area and work practices. 
•    Provide leadership, guidance, and direction to staff to create a quality-centric organization. 
•    Drive continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
•    Ensure the successful technical transfer of projects from the Tech transfer group to the GMP production group.
•    Establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or organizational metrics.
•    Organize and lead ad hoc cross functional teams to manage investigations and implementation of changes.
•    Act as manufacturing subject matter expert for assessments for change controls, validation protocols, and document changes.
•    Work closely with the production staff to troubleshoot process and equipment problems.
•    May create, revise, and edit SOP, batch records, and specs as needed.
•    Actively participate in all recruiting efforts to secure, onboard, and develop new staff members.
•    Manage GMP Employees.
•    Perform other tasks as assigned to support GMP Manufacturing that ensures sustainable right-first-time performance.

Job Qualifications

 
•    Bachelor of Science in relevant Science or Engineering discipline and 11+ years of related work experience; or
•    Master’s Degree in relevant Science or Engineering discipline and 8+ years of biologics experience.
•    High School Diploma/Associates degree in in relevant Science or Engineering discipline and 15+ years of biopharmaceutical manufacturing (GLP or GMP) experience.
•    Minimum of 3 years leading cGMP operations teams in fast-paced production environment.
•    Previous work in viral or vaccine production highly desired.
•    Training in Lean Six Sigma preferred.
•    Experience in biologics fill/finish preferred.
•    Previous experience in contract manufacturing preferred.

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. 


Vaccine Mandate
Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees. 


Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

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 18,000 employees within 100 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 >80% of the drugs approved by the FDA for the past 3 years.


Equal Employment Opportunity
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.

 

For more information, please visit www.criver.com.
  


Nearest Major Market: Washington DC

Job Segment: Biotech, Engineer, Pharmaceutical, Manager, Laboratory, Science, Engineering, Management