Analytical Development Manager (Biologics)

Req ID:  175936
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 Operations, Analytical and In-Vitro, this role will be responsible for overseeing different analytical projects (e.g. Method Development, Optimization, Qualification, Validation and Troubleshooting). A team of up to 10-12 Project Leaders will report to this role.

 

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

 

This main duties & responsibilities shall be:

  1.    Lead, mentor and develop the team of Project Leaders to advance their technical expertise and project management skills. 
  2.    Conduct Performance reviews and set goals
  3.    Review client study plans, SOPs and reports for Project Leaders and where necessary, oversee the execution of studies in strict accordance with study plan and SOPs ensuring full GMP regulatory compliance, where appropriate and safe working methods. 
  4.    Co-ordinate the implementation of an extensive program of analytical programs and methodologies for multiple clients. 
  5.    Responsible for updating Management on the overall status of each project including but not limited to providing information on the status of all relevant documents (protocols, reports, quality documents, etc), scheduling and revenue recognition.
  6.    Research and develop new analytical methodologies to meet client requirements and/or company strategic objectives.
  7.    Be involved in preparing costings and proposals based on protocols/project plan of proposed work by clients.
  8.    Participate in and provide information, both technical and financial, for any analytical related RFIs and RFPs. 
  9.    Assist in and provide regulatory and technical guidance on the transfer of methods from clients to the Analytical Services Department, where appropriate.
  10.    Ensure all new methods are validated in accordance with ICH guidelines or other regulatory requirements, where appropriate.
  11.    Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
  12.    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.
  13.    Participate in regulatory and client audits including compilation of responses and liaising with clients as required.
  14.    Responsible for supporting staff with deviations and laboratory investigation reports.
  15.    Provide technical support to the Analytical Services Department
  16.    Responsible for preparing ‘Technical Presentations’ and the delivery of same to the Analytical Services Department, support departments and to Clients as required.
  17.     Assist with troubleshooting of existing methods and participate in investigations. 

Requirements

 

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

 

  1. •    PhD in a relevant science discipline (e.g. Chemistry, Biochemistry or Biotechnology)
  2. •    A minimum of 5 years relevant experience within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry highly desirable.
  3. •    Proven track record of supervising/managing staff.
  4. •    Experience in method development and validation of analytical techniques essential. 
  5. •    Experience in leading and/or participating in method transfers in a regulatory environment is a distinct advantage,
  6. •    Ability to problem solve and work on own initiative.
  7. •    Excellent communication and organizational skills.
  8. •    Ability to project manage multiple projects.

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.