Laboratory Manager, Bioassay

Req ID #:  139415
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

Independently and effectively Manage Department personnel, activities and initiatives related to testing and ensure achievement of goals.  

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

  • Manage the conduct and quality of all aspects of operations, activities, and/or projects in the department. 
  • Provide oversight for all departmental sample processing.
  • Ensure that staff is provided with adequate training and that samples are processed accurately, efficiently and in compliance with GMP standards and any applicable regulatory guidelines.
  • Ensure on-time delivery of all client projects involving, but not limited to:
    • protein characterization and release testing,
    • method transfer, and assay validation 
  • Participate in and support cross functional communication and laboratory activities as necessary.  
  • May conduct technical review of study data.
  • Interview and select qualified non-exempt and exempt personnel.  
  • Monitor performance of direct reports.  
  • Regularly provide direction, coaching and counseling.  
  • Provide recommendations regarding personnel actions, including hiring, promotions and raises.  
  • Prepare and deliver salary and performance reviews of direct reports.
  • Partner with Human Resources to resolve disciplinary issues.  
  • Create appropriate personnel action paperwork.
  • Review and approve timecards.  
  • Coordinate vacation/time off schedules of staff. 
  • 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.
  • Resolve complex internal and external customer requests, inquiries, and complaints and provide technical assistance through delegation to subject matter experts as needed.
  • Share responsibility for developing/planning new product development by participation in client visits and conference calls.
  • Confirm that departmental equipment is maintained in good working condition through delegation of responsibilities and duties to subordinates.
  • Ensure departmental area(s) are maintained in a clean and orderly condition, presenting as audit ready at all times.
  • Oversee the development, writing, and timely review of SOPs, Protocols, and Amendments.
  • Recommend short- to mid-range operating objectives, organizational structure, staffing requirements and succession plans.
  • Collaborate with appropriate departments to coordinate performance of projects, discuss issues and prepare reports.
  • Determine and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
  • Serve as a model to departmental subordinates as it relates to effective time management, communication and utilization of resources.  
  • Provide leadership and motivation to departmental personnel.
  • Assist in the development of short- and mid-range operating objectives, organizational structure, and staffing requirements of the department.  
  • Assist in the development of a departmental plan for backup and succession of supervisory staff and key technical personnel.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Partner with management to plan for technical growth of staff and ensure that competencies meet current and future needs.
  • Assist in the development and recommendation of departmental budget.
  • Authorize expenditures in accordance with budget.  
  • Approve budget and expenses of subordinates.
  • Monitor quality of supporting services to the department such that projects are completed accurately and timely.
  • Provide the primary point of contact for such support group communication (lab-wide, site-wide, or company-wide). 
  • Serve as the department’s lead contact person for internal QAU issues.
  • Ensure compliance, follow through, and work to resolve issues that directly impact compliance.
  • Act as the primary contact, prepare for and participate in customer audits.
  • Respond to audit findings in a timely fashion.
  • Initiate corrective action, provide support and follow through on findings and action items to ensure adherence to protocols, SOPs, etc.
  • Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
  • Ensure staff training records are maintained and audit ready through delegation to subordinates.
  • Support the policy of equal employment opportunity through affirmative action in personnel actions.
  • Have an understanding of cGMP as they apply within the department operations.
  • Perform all other related duties as required.

 

MINIMUM QUALIFICATIONS:

  • Master’s degree or equivalent in Chemistry/Biotechnology or related scientific discipline. 
  • Minimum of 3 or more years of relevant laboratory/GMP experience, two or more years as a laboratory supervisor. 
  • An equivalent combination of education and experience with contract research or the pharmaceutical industry 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 biological industries is required.
  • Position also requires familiarity with general bioanalytical assays involving, but not limited to:
    • USP methodology,
    • HPLC, CE, MALDI-TOF MS, IEF, ELISA, SDS-PAGE and protein sequencing.
    • Exercises judgment within defined procedures and practices to determine appropriate action.
    •  Ability to collaborate effectively within a group environment.
    • Able to communicate (verbal and written) effectively in a small group or one on one setting.  
    • Computer proficiency in MS Word, Excel, Outlook, instrumentation and analysis software.
    • Ability to understand and use internal software programs such as LIMS required.
  • Must be able to remain in a stationary position 50% of the time while performing laboratory tasks.
  • Regularly observes, inspects, and interprets laboratory experiments, requiring close vision and the ability to adjust focus and detect and differentiate colors. 
  • Regularly lift and/or move up to 10 pounds and may occasionally lift and/or move up to 50 pounds. 
  • Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer. 
  • Must have strong written and verbal communication.

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 - M/F/Disabled/Vet.


 
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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