Associate Director, Analytical Development

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POST DATE 8/17/2016
END DATE 10/23/2016

Celgene Summit, NJ

Company
Celgene
Job Classification
Full Time
Company Ref #
360127
AJE Ref #
575905669
Location
Summit, NJ
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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br strong Description /strong br P Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. /P P The successful candidate will be highly motivated to work within a science focused, collaborative, multidisciplinary drug substance and drug product development environment to achieve the company's aggressive drug development targets. /P P STRONG Responsibilities will include, but are not limited to, the following: /STRONG /P P The Associate Director position will be responsible for managing the development and validation of analytical methodology for the characterization of our products and processes, the creation of fundamental product and process understanding, and the advancement of innovative approaches to drug development.  Support for drug candidates across all stages of development and, as needed, within our commercial product portfolio will be required. /P P The Associate Director should work with minimal supervision to support laboratory based de novo analytical methods development, chemical characterization studies and chemical stability characterization evaluations.  Where required, leadership oversight will include activities that will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures. /P P The Associate Director will have organizational, interdepartmental and interdivisional responsibilities with regards to leading workgroups, cross-functional teams, strategy development/implementation/execution, and process improvement initiatives. /P P ? Support drug substance process development including characterization of starting materials, intermediates and final API. /P P ? Support drug product formulation and process development including characterization of the process and finished product. /P P ? Develop, optimize and validate analytical methods. /P P ? Support drug substance and drug product impurity characterization and identification. /P P ? Generate clinical batch release and stability data. /P P ? Qualify/transfer analytical methodology to quality control and contract laboratories. /P P ? Where appropriate, oversee and manage the relationship with external partners. /P P ? Responsible for the hiring, training, and management of technical staff. /P P ? Provides mentoring and technical direction to other members of the staff, including those who may not directly report to the Associate Director. /P P ? Serve on and lead departmental, interdepartmental and project teams. /P P ? Report and discuss analytical results and conclusions both orally and in writing. /P P ? Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities. /P P ? Represent the company in discussions with regulatory authorities. /P P ? Serve on company due diligence teams assessing external product development opportunities. /P P ? Review analytical data for completeness and correctness. /P P ? Adhere to all relevant compliance requirements. /P P ? Ensure that all facilities, equipment and personnel are and remain in compliance with cGLP / cGMP, FDA and EMA requirements, appropriate SOPs and corporate policies. /P P *LI-KM1 /P P BIO-US /P