Technicial Manager - Analytical

Req ID:  83494
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.

 

Reporting to the Head of Analytical Strategies, this role will be responsible for overseeing different analytical project (e.g. Method Development, Optimization, Qualification and Validation). A team of 6-8 Project Leaders will report to this role.

 

We are seeking an experienced Analytical Technical Manager for our Biologics Division located in Ballina, Co. Mayo, Ireland

 

This main duties & responsibilities shall be:

 

  1. Assist Project Leaders with client study plans and the execution of studies in strict accordance with study plan and SOPs ensuring full GMP regulatory compliance, where appropriate.
  2. Research and develop new analytical methodologies to meet client requirements and/or company strategic objectives.
  3. Ensure all new methods are validated in accordance with ICH guidelines or other regulatory requirements, where appropriate.
  4. Oversee the quality of work produced by the team and ensure it is conducted in accordance with Standard Operating Procedures and the principles of GMP.
  5. To implement and supervise safe working methods within the team and to inform and instruct staff of these. Comply with all Health and Safety regulations and procedures.
  6. Responsible for providing feedback on their performance to project leaders working on Client specific projects.
  7. Be involved in preparing costings and proposals based on protocols/project plan of proposed work by clients.
  8. Assist in the transfer of methods from clients to the Analytical Services Department where appropriate.
  9. Participate in regulatory and client audits and liaising with clients as required.
  10. Assist Project Leaders in research technical information for incoming new enquiries.
  11. Responsible for compiling audit responses in conjunction with the team and the Analytical Functional Manager.
  12. Responsible for supporting staff with deviations and laboratory investigation reports.
  13. Responsible for preparing ‘Technical Presentations’ and the delivery of same to the Analytical Services Department team and to Clients as required.
  14. Liaise with consultants and external services (e.g. subcontract laboratories) as appropriate.
  15. Responsible for reporting project leaders progress information to Management.
  16. Provide technical support to scientific team, as required.
  17. Day to day liaison with clients regarding current and new projects.
  18. Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
  19. Generate new and update current standard operating procedures and risk assessments for various projects as required.
  20. Responsible for purchasing new equipment as required.

 

The following are minimum requirements related to the Analytical Technical Manager position.

 

  • PhD in a relevant science discipline (e.g. Chemistry, Biochemistry or Biotechnology)
  • A minimum of 5-7 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
  • Proven track record of supervising/managing staff.
  • Experience in method development and validation of analytical techniques essential.
  • Ability to problem solve and work on own initiative.
  • Excellent communication and organizational skills.
  • Ability to project manage multiple projects.

Job Summary

Designs and/or executes scientific testing strategies and studies. Leads assay development, assay validation or study conduct, or is involved in preparation of material [e.g. protein, nucleic acid, cells, etc.]. Reviews and interprets study data, communicates results to clients and writes final reports. Serves as Project Scientist, Principal Investigator, Contributing Scientist, Project Leader or Study Director, as applicable. Ensures compliance with protocols and all applicable SOPs. Troubleshoots and resolves assay or technical issues in the laboratory when scientific expertise is needed. May introduce new technologies or introduce improvements in existing technologies. Provides advisory functions to clients designing a program or experiment, dealing with specific dataset interpretation, or when appropriate answering questions from regulatory authorities.

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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.