Associate Director, Biologics Testing

Req ID #:  183214
Location: 

Shrewsbury, MA, US, 01545

For 70 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.

Basic Summary

Responsible for technical oversight and operational performance of one or more Biologics Testing Services functions including the Analytical, Biophysical, Bioassay and/or Mass Spectrometry Departments. Primary liaison for assigned key client(s) to establish and foster best practice initiatives, provide technical and operational consultation, enhance communication, and facilitate positive client relationships.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Provide technical guidance to staff, scientists and clients as needed.
  • Day to day oversight to ensure on-time delivery of all client projects related to biologics testing services.
  • Work within and external to the group to resolve scientific and technical issues.
  • Oversee acquisition and implementation of new technologies.
  • Ensure compliance with all applicable local, state, and federal regulations, including but not limited to GMP, FDA, and OSHA.
  • Supervise staff and provide excellent service to customers.
  • Responsible for refinement and development of assays as needed to meet current industry standards and the subsequent training of technical personnel in general laboratory skills; reinforce regulatory concepts (cGMP) and specific laboratory techniques.
  • Provide guidance to Customer Service and Sales departments in drafting proposals, reviewing proposals and handling customer relations.
  • Maintain assays in a state of current industry standard validation, including revalidation when necessary to meet regulatory expectations.
  • Document revisions to ensure the laboratory maintains its compliance status.
  • Participate in industry technical and trade groups to enhance the company's image as an industry leader, generate new business leads and strengthen market intelligence.
  • Interact closely with other Site department heads and Charles River personnel to ensure seamless Biologics Testing Solutions operations and client satisfaction.
  • Direct activities of assigned group(s) to ensure optimum performance of the group/function.
  • Responsible for personnel management activities such as:
    • scheduling,
    • personnel actions (hiring, promotions, transfers, etc.),
    • training and development,
    • providing regular direction and feedback on performance,
    • disciplinary actions,
    • preparing and delivering annual performance and salary reviews.
  • Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
  • Integrate activities with those of other major organizational units (e.g. segments, departments, functions).
  • Develop and recommend departmental budget and authorize expenditures.
  • Collaborate with site training to implement departmental training programs, including orientation.
  • Support the policy of equal employment opportunity through affirmative action in personnel actions.
  • Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
  • Perform all other related duties as assigned.

ADDITIONAL RESPONSIBILITIES

  • With respect to all assays and tests performed in laboratories managed, the Associate Director of Biologics Testing Services assures that:
    • Study or assay protocols, including any changes, are approved as provided by applicable regulatory requirements and that the protocols are followed.
    • All experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.
    • Unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.
    • Test systems, including reagents, live cells, equipment or other material are as specified in the protocol.
    • All applicable good laboratory or manufacturing practice regulations are followed, as applicable.
    • All raw data, documentation, protocols, specimens, and final reports are transferred for archiving during or at the close of the study.

 

MINIMUM QUALIFICATIONS:

  • Bachelor's degree (B.S./B.A.) or equivalent in Biochemistry, Biotechnology, Analytical Chemistry, Cell Biology, Virology, or a related discipline. M.S. or Ph.D. preferred.
  • 6 to 8 years’ experience in contract laboratory environment operating in a cGMP environment.
  • 3-5 years prior supervisory/management experience required.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Demonstrated leadership skills and knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biotechnology industries is required.

WORKING CONDITIONS:

  • May work with sharp objects, near toxic or caustic chemicals, and with biohazards.
  • May be exposed to fumes or airborne particles, unpleasant odors, and /or wet, humid and/or extreme temperature conditions.
  • May be required to wear personal protective equipment (PPE) according to OSHA regulations and company standards
  • This position requires occasional domestic and international travel.

Vaccine Mandate
Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees. 


Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.


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 18,000 employees within 100 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 >80% of the drugs approved by the FDA for the past 3 years.


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.


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