Senior Scientist

DUTIES AND RESPONSIBILITIES

This position is responsible for managing the provision of analytical support provided to ongoing product development projects, development of analytical methods, provision of analytical support to the development of products compilation of the analytical portion(s) of the chemistry manufacturing controls (cmc) section of submissions.

* Develop analytical methods to support the development of new products within the budgetary guidelines.
* Provide in-depth analytical support to product development activities.
* Develop and validate analytical methods to support product development.
* Design and implement stability protocols and special studies in support of product development activities.
* Provide in-depth analytical support to product development activities exhibiting an understanding of the state of art resources/equipment available in the market.
* Demonstrate an understanding of analytical chemistry at the research level
* Represent the department at project meetings.
* Contribute to the leadership of projects through the setting of realistic timelines and coordination of departmental activities so as to meet those timelines.
* Manage and train analytical chemists if under their supervision.

REQUIRED EDUCATION/EXPERIENCE/SKILLS

* Minimum qualifications A Ph.D. degree in Chemistry or equivalent with 2 years or more experience or MS degree in Chemistry with 5 years or more relevant experience or BS degree Chemistry with 10 years or more relevant experience.
* A working understanding of GLP's, GMP,s and regulatory guidance's as they relate to the products manufactured at Dey L.P.
* Experience with the development and validation of analytical methods.
* Must have a strong record of accomplishment in analytical chemistry and/or analytical development with excellent quantitative and qualitative analytical skills.
* Ability to think strategically and creatively along with exceptional communication and interpersonal skills.
* Working experience in a GMP environment
* Have proven people management skills.
* Must have experience with third party data.
* An understanding of the basic statistical concepts and working knowledge of one or more statistical and other technical software packages
* Strong Access, Excel, Word and Power Point skills.

DEY supports diversity in the work place. We are an Equal Opportunity Employer.