Associate Director, Immunoassay and Biomarkers

Req ID #:  205394
Location: 

Shrewsbury, MA, US, 01545

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

Oversee the direction and execution of daily operations in regulated (GLP) immunoassays, including ligand binding assays for PK/TK, immunogenicity, and biomarker testing. 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.

Job Qualifications

  • Oversee the day-to-day operations of the Immunoassay Laboratory:
    • Work with Scientific and operations staff to ensure available resources and assignments meet client needs.
    • Maintain the scientific, safety, and regulatory compliance integrity of the entire molecular biology process.
    • Provide technical leadership to scientific and technical staff from sample preparation through instrumental analysis to resolve analytical challenges in a timely fashion.
  • Drive development and adoption of optimized, uniform processes as beneficial to clients and staff.
  • Effectively collaborate with other sites and drive the implementation of best practices for the development, validation, and analysis of ligand binding assays (PK/TKA, ADA, and biomarker).
  • 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 HR 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.
  • Support new clients and Sales staff from early onboarding discussions into active operations. 
  • Ensure that departmental area(s) are maintained in a clean and orderly condition.  Work with laboratory support groups to identify equipment and service needs.
  • Key participant 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.
  • Perform all other related duties as assigned.

QUALIFICATIONS:
•    Education:  Bachelor’s degree (B.A./B.S.) or equivalent in a related science. Masters or Doctoral degree preferred.

  • 10 years related experience in the development and/or validation of ligand binding and biomarker assays is preferred (eg: ELISA, MSD, Ella, Quanterix, bDNA, hybridization ELISA).

•    Excellent verbal, written communication and organizational skills, strategic thinking and proven ability to understand and respond to critical business and industry issues.  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. Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development.  Proficient with computers and standard application software.  

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 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 crrecruitment_US@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.


Nearest Major Market: Worcester

Job Segment: Molecular Biology, Biology, Laboratory, Testing, Pharmaceutical, Science, Technology