Sr. Director, Manufacturing Sciences & Technology

Req ID #:  217761
Location: 

Hanover, MD, US, 21076 Memphis, TN, US, 38118 Memphis, TN, US, 38104 Memphis, TN, US, 38118

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

BASIC SUMMARY:
    
Reporting to the Site Director, the Sr. Director, Manufacturing Sciences and Technology will lead cross a cross functional team to provide Technical Leadership for new and existing client manufacturing.  The Director is responsible for all tech transfer operations to the Memphis Manufacturing Facility including manufacturing, QC, assay development and project management.  The incumbent is responsible for ensuring that these all-tech transfer activities are timely, efficient, and productive while adhering to client’s requirements and operational and quality parameters.  This position has a dotted line reporting structure to the Site Head of Quality.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Essential functions include, but are not limited to, the following:
  • Responsible for all aspects of product transfer from the process establishment stage to commercial Good manufacturing Practices (cGMPs) production. Responsible for ensuring that project objectives are achieved.
  • Responsible for ensuring that client expectations are met or exceeded, and timelines are adhered to.
  • Responsible for reviewing and analyzing data, design additional experiments, and write reports. This position will ensure a cohesive, integrated manufacturing environment and ensure that the transfer of technology is thorough and well-coordinated.
  • Responsible for the development and delivery of training materials to ensure that the operational, scientific, and analytical training of all employees involved with new processes/clients.
  • Responsible for liaison with the Quality Control, Quality Assurance, Supply Chain, Project Management, Facilities, and other GMP Quality Control units. This position leads technology transfer by collaborating with clients and internal departments on establishing new robust and cost-efficient manufacturing needed for clinical and commercial manufacturing.
  • Responsible for providing status updates for all tech transfer activities and develops schedules and milestones with Development group, Business, and Site leadership.
  • Ensures issues are resolved to meet project goals and deliverables.
  • May provide technical data or impact assessments for Deviations, CAPAs, or Change Control records.
  • Performs all other duties, as assigned

Job Qualifications

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

  • B.S. or Masters in an appropriate area of specialization and 10 years of appropriate experience; and/or training; or equivalent combination of education and experience.
  • Experience working in a GMP/ laboratory / Medical Device/Manufacturing environment required.
     

Compensation Data

The pay range for this position is $199,700/yr - $246,600/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Competencies

Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.
Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.
Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.
Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.

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.


Nearest Major Market: Baltimore

Job Segment: Pharmaceutical, Laboratory, Biology, Biotech, Supply Chain, Science, Operations