Project Leader - Cell Based Assay

Req ID:  157452
Location: 

Ballina, IE, F26D786

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.

 

 

We are seeking an experienced Project Leader for our Biologics Division located in Ballina, Co. Mayo, Ireland.

 

This role shall report to the Biosafety and Cell Based Assay Department Manager and the main duties & responsibilities shall be:

 

  • Research and develop new In-Vitro cell-based methodologies to meet client requirements and/or company strategic objectives.
  • Ensure all new methods are validated in accordance with ICH guidelines, where appropriate.
  • Draw up study plans and implement studies in strict accordance with study plan ensuring full GMP regulatory compliance as appropriate.
  • Liaise with the Quality Department for the generation of audit responses, deviation reports and for the compilation of study reports.
  • Responsible for leading laboratory investigations where necessary.
  • Responsible for reporting project progress information to Management.
  • Provide technical training to scientific team as required.
  • Day to day liaison with clients regarding current and new projects.
  • Involvement with regulatory and client audits.
  • Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
  • Generate new and update current standard operating procedures.
  • Generate risk assessments for various projects as required.

 

The following are minimum requirements related to the Project Leader position.

 

  • MSc. or PhD in a relevant science discipline (e.g. Cell Biology / Biomedical Science)
  • A proven track record and experience of working in a GMP regulated environment (EMEA/FDA) within the Pharmaceutical/Medical Device/CRO Industry.
  • Experience in study design, assay development, optimization, ICH analytical validation and project management.
  • Experience in In-Vitro bioassays essential (e.g. potency/proliferation/differentiation assays, flow cytometry, colorimetric assays, etc.).
  • Ability to project manage multiple studies.
  • Knowledge and experience with statistical software.
  • Ability to problem solve and work on own initiative.

Job Spec

 

We are seeking an experienced Project Leader for our Biologics Division located in Ballina, Co. Mayo, Ireland.

 

This role shall report to the Biosafety and Cell Based Assay Department Manager and the main duties & responsibilities shall be:

 

  • Research and develop new In-Vitro cell-based methodologies to meet client requirements and/or company strategic objectives.
  • Ensure all new methods are validated in accordance with ICH guidelines, where appropriate.
  • Draw up study plans and implement studies in strict accordance with study plan ensuring full GMP regulatory compliance as appropriate.
  • Liaise with the Quality Department for the generation of audit responses, deviation reports and for the compilation of study reports.
  • Responsible for leading laboratory investigations where necessary.
  • Responsible for reporting project progress information to Management.
  • Provide technical training to scientific team as required.
  • Day to day liaison with clients regarding current and new projects.
  • Involvement with regulatory and client audits.
  • Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
  • Generate new and update current standard operating procedures.
  • Generate risk assessments for various projects as required.

 

The following are minimum requirements related to the Project Leader position.

 

  • MSc. or PhD in a relevant science discipline (e.g. Cell Biology / Biomedical Science)
  • A proven track record and experience of working in a GMP regulated environment (EMEA/FDA) within the Pharmaceutical/Medical Device/CRO Industry.
  • Experience in study design, assay development, optimization, ICH analytical validation and project management.
  • Experience in In-Vitro bioassays essential (e.g. potency/proliferation/differentiation assays, flow cytometry, colorimetric assays, etc.).
  • Ability to project manage multiple studies.
  • Knowledge and experience with statistical software.
  • Ability to problem solve and work on own initiative.

 

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 characterzation, 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 17,000 employees within 90 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 to $2.67 billion. 

 

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 2019.