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Associate Director, Laboratory Support…
- Charles River Laboratories (Reno, NV)
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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
The Associate Director of Laboratory and Logistics position at Charles River Laboratories in Reno, NV is responsible for overseeing the laboratory logistics and support functions (e.g., Sample Management, Data Management, Scientific Coordination, and Scientific Writing teams) in the Laboratory Sciences department. This leadership role drives operational excellence by ensuring clinical and non-clinical study samples, data, and reports are managed in a compliant, secure, efficient, and timely manner, in accordance with sponsor and regulatory specifications.
* Sample Management Oversight: Oversee the Sample Management team to ensure biological specimens (e.g., plasma, whole blood, tissues, etc.) are properly received, labeled, stored, tracked, and dispositioned for clinical and non-clinical studies.
* Data Management Leadership: Oversee the Data Management team to ensure efficient review of laboratory data and study reports according to CRL Standard Operating Procedures (SOPs), Business Operating Procedures (BOPs), study documentation (e.g., Plans, Protocols, and Methods), relevant regulations, and sponsor specifications.
* Scientific Coordination and Scientific Writing Oversight: Oversee Scientific Coordinators and Scientific Writers to ensure study data and reports progress through the process and are delivered to the sponsor within the agreed timelines, according to their specifications. Ensure adequate support of scientific staff is maintained. Ensure study progress is appropriately tracked and communicated to all stakeholders.
* Stakeholder Collaboration: Liaise with sponsors, clinical project managers, scientific and operational staff, and other internal teams to align on deliverables, timelines, and quality expectations.
* Staff Management: Lead, train, and mentor a multidisciplinary team, fostering a culture of accountability and continuous improvement. Develop and oversee study macro scheduling at time of study award and liaise with Operations and Scientific management to adjust the schedule as necessary on an ongoing basis. Ensure appropriate systems are kept up to date with accurate delivery dates.
* Regulatory Compliance: Ensure all processes adhere to the relevant regulatory guidelines, maintaining audit-ready documentation and addressing discrepancies promptly.
* Ensure appropriate resources are provided for the conduct of non-clinical and clinical studies by monitoring the daily macro level scheduling through supervisors and making recommendations to management for expected additional staffing needs based on review of projected workload.
* Resolve technical and operational issues inter- and intra-departmentally (e.g., troubleshooting procedural and technique issues).
* Continuously review and improve departmental processes and procedures to uphold the highest industry standards and sponsor requirements while also implementing efficiencies.
Job Qualifications
* Education: Bachelor's degree (B.A./B.S.) or equivalent in a biological science or related field
* Experience: Minimum 10 years' experience working in a hospital, contract research/manufacturing, or biotech/pharmaceutical industry conducting scientific research. Experience working in a regulated (GMP, CAP, CLIA, GLP, etc.) laboratory environment required. Management experience required. At least 3 years' experience in a supervisory/management role.
* An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
* Certification/Licensure: None.
* Other: Excellent verbal and written communication, and organizational skills. Demonstrated independent analytical and problem-solving abilities. Demonstrated proficiency in managing a team supporting or working in a laboratory environment
Note: The pay range for this position is $105,000 - $115,000 anually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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.
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