Director, Plasmid Production

Director, Plasmid Production Req ID #:  141072 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 Director, Plasmid Production, leads the Plasmid Manufacturing department and provides overall leadership for projects and ensuring delivery against work orders, budgets, as well as business plan goals. This position works cross-functionally with several departments/personnel to ensure the close coordination and planning necessary for GMP plasmid production. Maintain compliance of all systems in the plasmid manufacturing facility.

Essential Responsibilities:

•    Provide oversight and supervision of staff and resources performing plasmid production (research grade, GMP-Ready, and GMP Grade Plasmid DNA) such as process and method development and validation, stability, QC, etc. 

•    Manage the plasmid in-process assays.

•    Manage and execute the work activities of group and associates, resource planning and allocation, client communication, technical document generation and review, mentoring technical staff, troubleshooting method and product-related issues, draft Batch Records, and conduct Good Manufacture Processing compliant with global regulatory requirements.

•    Work collaboratively with Project Directors/Leads from all functional areas (i.e., Engineering, Quality, Process Development, Validation, Metrology, Materials Management, Regulatory Affairs).

•    Lead the development and implementation of all operational procedures and policies related to Vigene Bioscience Plasmid Manufacturing Operations.

•    Ensure that production facilities are maintained at a high standard of readiness (validated, calibrated, qualified, continually operational).

•    Ensure all staff maintain an appropriate level of training.

•    Identify and mitigate risks in manufacturing operations that could negatively impact projects and delivery of treatment to patients.

•    Establish and effectively manage department annual operating budgets for all of the site’s Plasmid Manufacturing Operations.

•    Establish robust scheduling systems to maximize the use of facility and staff to optimize the capacity and throughput of operations continually. Job Qualifications

•    Master's degree and at least 4-6 years of experience that provides the knowledge, skills, and abilities to perform the job; Ph.D. is preferred.

•    Experience with Process Validation and Commercial Biologic’s manufacturing.

•    Excellent understanding of cGMP principles, including validation and the regulatory path for Biologic drug approval.

•    Experience in risk management and preferably experience in lean manufacturing experience.

•    Technical/Scientific expertise in biologics and aseptic manufacturing.

•    Demonstrated Client Interaction and Project Management experience.

•    Proven ability in managing and coaching experienced research scientists and associated projects.

•    Strong Molecular Biology knowledge and background.

•    Relevant experience with research grade plasmid DNA production and GMP Plasmid DNA production and microbial fermentation and purification.

•    Demonstrate outstanding technical acumen, operational understanding, and GMP compliance in building and running the Manufacturing Operations Department.

•    Provide oversight for the maintenance/retrofit of existing plasmid manufacturing facility.

•    Provide critical leadership for interactions with various agencies (e.g., regulatory agency meetings such as FDA, EMA, etc.)

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: Manager, Biotech, Engineer, Pharmaceutical, Management, Science, Engineering, Research