Job Description

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.
Duties and Responsibilities:
Provides strong, independent technical leadership to technical personnel
Leads, designs and performs method development (i.e. bioassay and mycoplasma) and validation of new test procedures for incoming projects
Functions as Technical Reviewer for A2LA accredited tests and non-accredited tests
Evaluates analytical results to form interpretations of data and renders scientific opinions for client-driven projects
Serves as subject matter expert (SME) in area of specialization, established standards for regulatory compliance
Serves as technical liaison with Customers with regards to technical services and performs Customer site visits where required
Prepares documents including methods, procedures, standard operating procedures (SOP), study protocols, summary reports
Assures that SOPs are in accordance to ISO 17025, cGMP and other regulatory requirements
Provides problem-solving skills for test procedures and investigations within laboratory unit
Responsible for notifying Quality Assurance and Senior Management of any compliance deficiencies or concerns in a timely manner
Monitors all proficiency-based testing and ensures compliance
Participates in internal Quality Audits, System Audits, Audits conducted by external agencies and Regulatory Authorities
Participates in quarterly management review
Drives process, quality and safety improvement initiatives within the department
Provides coaching and mentoring to Technical personnel
Supports the Laboratory Manager in all relevant functions
Qualifications:
Bachelor of Science or any related field; MSc. preferred but not essential
Minimum 2-6 years of relevant QC microbiological experience working in an ISO17025 / GMP laboratory environment
Experience in method validation and development, method transfer, qualification activities in regulated laboratory
Good knowledge of ISO 17025, cGMP and other regulatory guidelines
Good understanding/working knowledge of Project Management and Measurement Uncertainty (MU)
Good technical understanding and judgement
Good interpersonal and communication skills across cultures
Team player with ability to work in cross-functional teams as well as independently depending on requirement of task on hand
About Discovery
Discovery from Charles River is industry-proven in the successful development of novel therapies, with over 350 patents and 80 preclinical drug candidates delivered to our sponsors in the past 17 years. Backed by more than 650 scientists, our comprehensive, integrated portfolio employs the latest technology and platforms to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. Our client-focused, collaborative approach creates true partnerships that anticipate challenges, overcome obstacles, and move us forward together on the journey of getting new drugs to market.
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.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.