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Principal Scientist Analytical

Req ID #:  44627
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.

Job Summary

We are seeking a Principal Scientist Analytical Services for our Biologics site located in Shrewsbury, MA.

 

In this role, they will serve as a Principal Scientist responsible for the management and oversight of all assigned studies within the Biotherapeutic Analytical Characterization group. Additional responsibilities include serving as primary scientific contact for key clients and the management of the on-site support of their programs, as well, as the support of specialty studies.

  • Function independently and be a technical expert in the direction and execution of biotherapeutics, techniques include, but not limited to, electrophoresis (CE, IEF, PAGE), chromatography (HPLC, UPLC, IC), and spectrometry (UV/Vis, Fluorescence), as required.
  • Provide oversight of the laboratory and mentor research staff in areas such as protocol interpretation, method development and refinement, study related problem resolution, and technique validation, as well as, providing scientific expertise in study conduct, design and interpretation.
  • Oversee Sponsor interactions, including scientific program development, consulting on study and program design, scheduling, conduct, and reporting. Communicate and provide guidance for client issue resolution and interaction concerning regulatory issues.
  • Generate draft/final protocols for studies in conjunction with the sponsor and internal departments (research staff, client services, et al.); ensure that study protocols are amended to accurately reflect any changes in, scope of work or deliverables, in a timely fashion.
  • Independently review, interpret, analyze, evaluate, and discuss study results with research staff and Sponsor. 
  • Perform tabulation and statistical analyses of study data, as required.
  • Prepare high quality final reports appropriate for the study, including integration of supporting subcontractor(s)’s reports into final reports as required.
  • Participate in the proposal management and bid development process, serving as a key scientific contact for new business generated from established business relationships within the functional organization.
  • Organize study assignments of direct reports, providing mentoring and technical guidance for the development and execution of studies to generate high quality scientific data within accepted regulatory compliance,
  • Provide scientific and technical leadership to direct reports to resolve analytical challenges in a timely fashion, including research and development of new methodologies in study conduct.
  • Provide regular coaching and counseling to direct reports. Prepare and deliver salary and performance reviews; review and approve salary appraisals initiated by direct reports.

 

Job Requirements

The following are minimum requirements related to the Principal Scientist Analytical Services position.

  • Bachelor’s degree (B.A./B.S.) or equivalent in a related scientific discipline. M.S. or Ph.D. preferred
  • Minimum nine years of relevant experience within a contract research, academic or pharmaceutical industry, including expertise in the core competencies of characterization and analysis of biotherapeutics. Also requires a full understanding of GLPs (cGMP preferred), and departmental/company SOPs.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Demonstrated expertise in the field of characterization and analysis of biotherapeutics (proteins and peptides) is required. Exceptional analytical and problem solving capabilities. Demonstrated leadership skill as they pertain to intra- and interdepartmental initiatives, Sponsor interaction and business development. Effective written and verbal communication skills. Ability to manage multiple moderate to highly complex projects, prioritizes work, and meets deadlines. Capable of anticipating and recognizing potential problems within programs and effectively communicate alternatives to client’s in a meaningful fashion.  Must have proven record of delivering quality service to customers on time and on budget.  Proficiency in the use of standard software including Microsoft Excel, Word, PowerPoint, etc. and with standard laboratory calculations.
  • While performing the duties of this job, the employee is regularly required to effectively communicate regarding study conduct with internal personnel and external scientific associates and client.
  • Must be able to read, understand and verify scientific data.
  • Must be able to wear a respirator in compliance with OSHA regulations.
  • General office and laboratory working conditions, the noise level in the work environment is usually quiet.
  • While performing the duties of this job the employee is regularly required to wear personal protective equipment (safety glasses or goggles, face shield, gloves, respirator et al.), work near toxic or caustic chemicals, and work with biohazards.
  • The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and extreme temperatures

 

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 14,000 employees within 80 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 agencies and hospitals and academic institutions around the world. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

 

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 ~85% of the drugs approved by the FDA in 2018.

 

Equal Employment Opportunity 

 

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet

 

 

 


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