Associate Director, Immunoassay

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

This onsite role will oversee the direction and execution of daily operations in regulated preclinical and clinical space, including ligand binding assays (i.e. bioanalysis, immunogenicity, biomarker), and immunology assays (i.e. flow cytometry, receptor occupancy, functional cell-based assays, Elispot, cytokine release assays). Responsible for planning, implementing, and interpretation of scientific studies from method development and validation through sample analysis and delivery of results to clients. Additional responsibilities may include serving as the primary scientific contact for internal and external clients and the on-site support of their programs. Responsible for the overall management of scientific staff. Provides oversight, guidance, and training for laboratory teams. Develops and maintains cross functional and departmental relationships to ensure studies are executed to meet sponsor timelines. Promotes, implements, and ensures maintenance of effective processes and procedures.

Oversee the day-to-day operations of the Immunochemistry and Immunology Laboratory. The key responsibilities include:
o Work with Scientific and operations staff to ensure available resources and assignments meet client needs.
o Maintain the scientific, safety, and regulatory compliance integrity of the entire bioanalytical process.
o Provide hands on technical leadership to staff from sample preparation through instrumental analysis to resolve analytical challenges in a timely fashion.
o Interface with clients on a regular basis to share processes and capabilities in support of ongoing studies and business development activities.
• Effectively collaborate with other Charles River sites and drive the implementation of best practices for development, validation, and sample analysis.
• Participate in the proposal management and bid development process, serving as a key scientific contact for new business generated from established business relationships.
• Monitor the performance of group staff, including identifying training and development needs within the group. Provide regular coaching and mentoring. Assist in preparation and delivery of salary and performance reviews of direct reports. Interview and assist in the selection of qualified personnel. Recommend personnel actions, including hiring, promotions and raises. Partner with Human Resources and departmental management to assist in the handling of disciplinary issues. Draft appropriate personnel action paperwork.
• Recommend short-range operating objectives, organizational structure of direct reports and staffing requirements. Assist in the development of a departmental plan for backup and succession of key technical personnel.
• Ensure that departmental area(s) are maintained in a clean and orderly condition. Work with laboratory support groups to identify equipment and service needs.
• Participate in strategic planning for securing and retaining new clients. Assist in planning and developing new services intended to broaden the client base.
• 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.
• Perform testing facility management duties for the site as delegated by senior management.

Note: The pay range for this position is $160,000 - $225,000,000 annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location

Job Qualifications

Education: Bachelor’s degree (B.A./B.S.) or equivalent in a related science. Masters or Doctoral degree preferred.
Experience: Minimum of 10 years related experience in the development and validation of ligand binding and/or immunology assays is preferred (eg: ELISA, MSD, Ella, Quanterix, hybridization ELISA, flow cytometry, receptor occupancy, mammalian cell culture, PBMC isolations, functional cell-based assays, Elispot, cytokine release assays).
• 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, written communication and organizational skills. Strategic thinking and proven ability to understand and respond to critical business and industry issues. Excellent client relationship and communication skills. Demonstrated independent analytical and problem-solving abilities. Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Knowledge of applicable international guidelines for all assigned types of studies. Proficient with computers and standard application software. Ability to interact appropriately with all levels of employees. Proven leadership skills and the ability to work effectively with and direct the efforts of team members.

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.

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