Location: Ashland,OH, USA
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**
Direct the science and business involved in the conduct, direction, and execution of Bioanalytical Chemistry studies. Provide scientific direction, oversight, and guidance to staff. Maintain and implement efficient processes and procedures to provide high quality standards of study design and timely reporting. Contribute to new business development. Keep abreast and maintain a broad knowledge of state-of-the art principles and theories.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Provide senior level review of protocols, reports and related documents for appropriate scientific content and interpretation in collaboration with other senior staff.
* Oversee and ensure report timelines are maintained and perform quality assessments to ensure high quality study design and timely reporting.
* Interact with Sponsors, consultants, and other outside contacts; interact with government representatives and Sponsors when site visits are conducted.
* Identify key regulatory requirements and guidelines that pertain to preclinical and clinical testing and specialty services that we provide.
* Promote and facilitate new business development. Evaluate opportunities and recommend other technologies that may be established.
* Ensure departmental policies, practices and procedures adhere to GLP/FDA regulations as they relate to the conduct of preclinical studies. Establish new policies and practices to ensure compliance with all applicable regulations and corporate policies.
* Ensure coordination of study bids, study design and conduct, protocol review, consultant interactions, staffing needs, analysis, and reporting of Laboratory Sciences studies.
* Represent the organization to industry groups, key customers, representatives of government and regulatory agencies and the general public.
* Ensure a positive employee relations position is maintained and that effective communication is maintained to inform employees of plans and progress.
* Interview and select qualified exempt-level departmental personnel. Recommend, review, and approve personnel actions, including hiring, promotions and raises. Partner with Human Resources in the handling of disciplinary issues.
* Ensure that management training and development needs are identified, and programs initiated.
* Monitor performance of direct reports. Provide regular coaching and counseling. Prepare and deliver salary and performance reviews. Review and approve performance and salary appraisals initiated by direct reports.
**Job Qualifications**
ESSENTIAL DUTIES AND RESPONSIBLITIES CONTINUED:
* Develop operating objectives, organizational structure, and staffing requirements. Oversee the development of a departmental plan for backup and succession of key departmental personnel.
* Develop and recommend departmental budget. Authorize expenditures in accordance with budget.
* Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
* Direct the development and communication of departmental systems, SOPs, policies, and procedures. Partner with Human Resources to develop and approve departmental job descriptions; ensure communication of duties and responsibilities to employees.
* Develop business leads to ensure the company's financial success.
* Perform testing facility management duties for the site as delegated by PCS senior management.
* Perform all other related duties as assigned.
QUALIFICATIONS:
* Education: Master's degree in Biochemistry or a related scientific discipline, preferred. Ph.D. recommended.
* Experience: 7 years relevant laboratory experience in a contract research organization, biotechnology, or pharmaceutical environment. 5 years management/leadership experience.
* An equivalent combination of education and experience may be accepted as a satisfactory substitute.
Compensation Data
The pay range for the position is $160k-$200k. 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 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 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, 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 ...@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.
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