Associate Director, Immunoassay

at Charles River Laboratories in Skokie, Illinois, United States

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.

IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.

Job Summary

BASIC SUMMARY:

The Associate Director, Immunoassay is responsible for the scientific and regulatory integrity of studies tested at the Charles River, Skokie site. This teammate will serve as Test Facility and Test Site Management and will be a member of the site Leadership Team for Charles River, Skokie. This teammate will communicate with clients, work with Client Services to help scope new projects, and partner with other Safety Assessment sites to harmonize and align scientific and business practices in Biomarker and Immunoassay. This teammate is also responsible for high-level training of employees in Immunoassay and is a subject matter expert in clinical biomarker and cell-based assay development.

RESPONSIBILTIIES OF THE ROLE:

+ Serve as subject matter expert on ligand binding and cell-based assay development, intended to support clinical and non-clinical PK, biomarker, and immunogenicity studies.

+ 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.

+ Identify training and development needs of direct reports. Develop and oversee the implementation of departmental training programs, including orientation; monitor training programs to ensure ongoing effectiveness.

+ Direct the development and communication of departmental systems, SOPs, policies and procedures. Partner with HR to develop and approve departmental job descriptions; ensure communication of duties and responsibilities to employees.

+ Interview and select qualified departmental personnel. Recommend, review and approve personnel actions, including hiring, promotions and raises. Partner with HR in handling disciplinary issues.

+ Recommend and implement techniques and instrumentation to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state of art practices.

+ Provide scientific oversight of study design, preparation of protocols, interpretation and reporting of data.

+ Guide the planning and execution of scientific research and/or critical development strategies.

+ Responsible for regulatory compliance and quality analysis of study data.

+ Develop and maintain client/sponsor relationships and participate in business development.

+ Support the policy of equal employment opportunity through affirmative action in all personnel actions including but not limited to recruiting, hiring, promotions, training, work assignments, and salary actions.

+ Perform all other related duties as assigned.

The pay range for this position is $145k-$170k. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

QUALIFICATIONS:

+ Subject matter expert in cell-based and clinical biomarker assay development.

+ Experience developing regulated assays on Luminex, ELISpot, and Flow Cytometry platforms is a plus.

+ Education: Bachelor’s degree (B.A./B.S.) or equivalent in biology, chemistry or related field; PhD or MS is strongly preferred.

+ Experience: 7 to 10 years in an applicable laboratory environment. 3 years supervisory/ management experience. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

+ Has managed a team that operates and complies with GLP regulations; having worked in a lab that operates and complies with GMP, CAP/CLIA, or ISO 15189/ 13485 regulations is a plus.

+ Certification/Licensure: None

+ Other: Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Ability to interact appropriately with all levels of employees. Demonstrated knowledge and full understanding of GLP regulatory requirements, site Standard Operating Procedures (SOPs), company practices, and industry standards. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and with standard laboratory calculations.

PHYSICAL DEMANDS:

+ Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.

+ Regularly provides information to and receives information from/through various technologies, media, sources and contacts. Must be able to accurately exchange accurate information in these situations.

+ Must occasionally move about inside the office to access file cabinets, office machinery, etc.

WORK ENVIRONMENT:

+ General office working conditions, the noise level in the work environment is usually quiet.

+ While performing the duties of this job the employee may occasionally be required to wear protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, boots), work near toxic or caustic chemicals, work with biohazards, and/or work with live animals with risk of exposure to allergens and/or zoonotic diseases. The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and/or wet, humid and/or extreme temperature conditions.

COMMENTS:

+ This position may require occasional travel

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.

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 120 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 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