Lead Product Consultant Cognizant
Cognizant
Office Location
Full Time
Experience: 15 - 15 years required
Pay:
Salary Information not included
Type: Full Time
Location: Chennai
Skills: Science, Pharmacy, Chemistry, Biologics, cGMP, Regulatory documentation, Compliance, CMC, Therapeutics, Drug manufacturing, Analytical test methods
About Cognizant
Cognizant is a multinational information technology services and consulting firm headquartered in the United States. Its headquarters are located in Teaneck, New Jersey, in the United States. Cognizant is listed on the NASDAQ-100 under the symbol CTSH.
Job Description
Job Summary CMC SME Responsibilities Adv degree in science pharmacy chemistry or a related technical area. Overall 15+ yrs experience with at least 8+ years in CMC area implementing solutions life cycle management of products etc Broad knowledge of biologics and therapeutics Good understanding of drug manufacturing activities and processes drug substance process development and cGMP manufacturing at external contract manufacturing and development organizations (CDMOs) Evaluating change controls and deviations related to drug products. Experience with late-stage development of biologic drug products Experience with regulatory documentation including regulatory commitments and quality documentation according to Good Manufacturing Practice. Good compliance and regulatory understanding Ability to provide solutions for drug substance development manufacturing and CDMO management. Understanding of other departments that influence CMC work and all phases of preclinical and clinical development. Understanding of development and validation of analytical test methods for drug substances,