Sign In
 [New User? Sign Up]
Mobile Version

Associate Director, Scientific Analytical Integrator Biologics CMC

Teva Pharmaceuticals USA


Location:
West Chester, Pennsylvania 19380
Date:
06/02/2017
2017-06-022017-08-01
Job Type:
Employee
Job Status:
Full Time
Shift:
1st Shift
Teva Pharmaceuticals USA
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

Overview

 Teva Biologics is Growing! Are you a Biologics R&D professional who is ready for your next challenge? 

With a world-class global biologics R&D team and an exciting pipeline of potential new medicines, there has never been a better time to be in Teva's Biologics R&D group.   We are expanding our biologics hub in West Chester, PA and have amazing opportunities for talented people. 

West Chester Pennsylvania is home to our CMC and Bioassay centers of scientific excellence, housed in state of the art facilities with full GMP production capability. Teva R&D is built on a foundation of amazing people who have created a culture of creativity, intellect, exacting standards, entrepreneurship and passion. This team is truly powered by the challenge of making the impossible possible.  Come and be part of something special!  We currently have available an exciting opportunity located in our West Chester, Pennsylvania location:

Scientific (Analytical) Integrator, Biologics CMC Project Manager/ Associate Director

Summary

The Biologics CMC group is seeking an Analytical Integrator who will lead the team for CMC projects, provide technical and strategic leadership, and represent the team to develop analytical and stability strategy. This person will work across functional teams to include Regulatory and Quality to streamline project timelines and initiatives.

Responsibilities

Analyze and integrate the following plans:

o             Product testing plan

o             Reference standard plan

o             Stability plan

o             Comparability plan

o             Specification development

o             Analytical method validation and transfer plan

Additional Responsibilities

             Serving as a liaison to communicate analytical and stability strategy to other function teams or units

             Tracking the progress according to overall CMC project and analytical development analytical timeline

             Authoring and reviewing IND and BLA for relevant sections

             Providing strategy on regulatory response and authoring responses as appropriate

             Managing all analytical post-approval commitments

             Overseeing CMO or Teva production sites for analytical and stability work ; reviewing stability data generated from CRO or CMO

             Participating CMC technical meeting as a analytical lead and supporting other analytical leads as needed

 

 

Requirements

Qualifications:

•       PhD (Preferred) with 7 years of industry experience, MS with 10-12 years of industry experience or BS with 15 plus years of industry experience. Degree should be in Biology, biochemistry, or related sciences.

             Strong leadership and effectively working in a matrix environment

             Strong time management and organization skills

             Strong oral and written communication skill

             Hands-on experience in analytical development

             Biologics CMC development knowledge and experience highly desirable

             Quality control, quality Assurance or regulatory experience desirable

             Knowledge of regulatory requirements and standards (FDA, EU, ICH, ISO, USP)

Please apply to: https://jobs-tevapharm.icims.com/jobs/19083/analytical-integrator-biologics-cmc--associate-director/job


Featured Jobs[ View All ]