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.Role Summary The Sr. Director Operations leads the development, implementation, and adherence to all GMP procedures and policies related to commercial production. The Sr. Director has oversight of Materials Management, MS&T and Manufacturing and is responsible for planning, coordinating, and scheduling of client processes from clinical through commercial product launch. The Sr. Director champions a progressive culture of continuous improvement and leads their respective teams by example and influence. The role has overall responsibility for developing a culture to support client programs with internal and external partners to provide phase appropriate development strategies which meet the rigor and interpretation of regulatory authorities.Key Responsibilities and Duties:
Serve as the subject matter expert in the areas of Material planning, production, and technology transfer from Process Development to Production.
Day to day management of large teams and oversight for right the first-time execution and timely delivery of client product.
Establish, direct, and monitor implementation of appropriate CMC/BLA development methodology and specifications for intermediates, active pharmaceutical ingredients (APIs) and drug products (DPs)
Partner with cross-functional teams to drive on time delivery and quality standards.
Support of organizational development and cultural leadership.
Create a positive motivated team-centric environment that attracts, retains, and develops the top talent.
Work closely with external CRO/CDMO collaborators to meet strategic company goals and business plan.
Provide detailed review and approval for protocols, reports, and raw data for production functions.
Identify, evaluate, select, and develop relationships while actively managing external parties (CROs, CMOs, CMC clients, Government agencies, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets and timelines, and oversight on due diligence efforts.
Participates as CMC/BLA subject matter expert in quality audits.
Establish credibility as an SME for all production issues inside and outside the organization.
Work closely with QA, QC, Process Development and BD departments to ensure project timelines are met.
Coach and mentor, the internal scientific teams engaged in analytical support, to facilitate product candidate molecule development.
Other responsibilities as needed.
Job Qualifications
Extensive experience Running an operation in a Viral Vector Production Role
Preferred Lentivirus and AAV experience.
Strong preference for overseeing operations right through commercial launch.
Experience with large molecule analytical/physicochemical testing strategies and characterization of complex vectors.
Experience in leading Regulatory audits and commercial operations.
Effective communication skills, with the ability to build strong relationships with key individuals at CMC suppliers and interact effectively in multidisciplinary teams both internally and externally.
Bachelor's Degree in Biology or related field
10+ years in operations management/leadership experience in a cGMP environment, with a specific focus on virology.
Extensive review and auditing experience in production methodologies
Working knowledge of viral vector and/or vaccine development
Knowledge of ICH/USP/EP/JP guidelines as it relates to Manufacturing Development
Thorough knowledge of cGMP and regulations applicable to the FDA and comparable international regulatory agencies.
Technical understanding of lot release test methods.
Excellent verbal and written communication skills.
Working knowledge of Quality Systems (QS) such as Training, Deviation Management, CAPA, Supplier Management, and Documentation Control, and the applicability of quality systems to the Analytical operations.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Compensation Data The pay range for this position is $180,000 to $220,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.About Biologics Testing SolutionsWith 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 RiverCharles 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 OpportunityCharles 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 crrecruitmentUS@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.225223
