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Director R&D Department- Nitosamine

Date: Jan 13, 2021

Location: Ambernath, IN, 421506

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

  • Expertise in Synthetic Organic Chemistry.
  • Evaluate the formation of potential genotoxic impurities/Nitrosamines by looking at the route of synthesis of APIs, their intermediates and processes.
  • Sound knowledge on regulatory guidance on Nitrosamines and other PGIs.
  • Perform literature search to verify if the synthesis of nitrosamines (SciFinder) if available before contacting custom synthesis lab
  • Responsible to contact custom synthesis lab for getting the impurities synthesized
  • Work closely with procurement in order to outsource the impurity either by direct purchase or custom synthesis.
  • Responsible to get API samples from the site and monitor shipment to the custom synthesis lab
  • Monitor impurity synthesis of Nitrosamines
  • Able to guide the outsourced lab in case chemical difficulties are encountered
  • Provide clear managerial tools for status update.
  • Manage the communication and provide documents requested by Teva toxicological department in case Ames test is required

Qualifications

Ph.D

Function

Research & Development

Sub Function

Drug Development and Preclinical Studies

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.