Senior Manager Pharmacist - H/F - CDI

Req ID #:  45104
Location: 

Châtillon-sur-Chalaronne, 01, FR

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 currently looking for our future Senior Manager for our Biologic’s entity. Supervising a team of 12 people including two direct reports on our site located in the state of Ain (01), France - an hour away from Lyon - here are the main Manager’s missions / responsibilities:

 

Operational and Quality management:

  • Be the Pharmacist in Charge for Charles River France GMP activities and be responsible for Data integrity and Quality Control Testing
  • Organize and manage regulatory inspections and customers’ audits
  • Manage GMP batch release Quality Control testingSign results of Quality Control Testing, and provide technical expertise to customers
  • Manage OOS, Deviation, CAPAs as well as customers’ claims
  • Lead continual improvement of the activity


Growth and Development:

  • Identify areas of development based on customers’ needs, with support of our Sales department.
  • Elaborate business cases, identify needs in terms of investments and human resources
  • Develop the site by setting up new assays
  • Be the expert for method transfer from customers


Financial performance :

  • Lead the budgeting, investment and forecast process
  • Lead financial reporting meetings to top management
  • Improve operational costs for each type of test
  • Define selling prices with support of Sales


Commercial:

  • Participate in customers’ visits with Sales team, projects followup, new assays development
  • Help marketing team to develop commercial documentation and marketing materials
  • Participate in conferences to promote and present our activities
  • Support generation of  proposals, with support of Sales and Customer Service Department


Job profil :

  • In his/her quality of Pharmacist, our future candidate need to be registered in the quality of Pharmacist Manager (Section B) within the French College of pharmacist. Pharmacien Responsable inscriptible en Section B de l’Ordre des Pharmaciens.
  • We are looking for a candidate fluent in both French and English, an extra knowledge in German is appreciated
  • This position requires a 7 to 10 years minimum expertise in Quality Control testing in a regulated environment (FDA, EU GMP, US GMP) with at least 2 to 3 years of  method transfer experience as well as a certain knowledge in techniques like cell culture, cell based products, immunization, immuno-assays
  • Having an existing professional network and a taste for continuing to expand it further is a plus.
  • Travel needed about twice a month
  • Home-office up to one day a week
     

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

 

 

 


Job Segment: Biotech, Claims, Manager, Pharmaceutical, Science, Insurance, Management, Research