Regulatory Affairs: Associate Director, Cmc & Analytical Services

Year    Hyderabad, Telangana, India

Job Description


Cellix Bio employees and teams apply sound science to develop and deliver medicines that focus on unmet medical needs around the world. Our current prescription products at various stages of development target to serve patients across therapeutic areas including metabolism, immunology, infectious diseases, neuroscience, ophthalmology, and oncology. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. You will help make an impact on people\xe2\x80\x99s lives and change futures every day. We are equally committed to bringing out your best and fostering a collaborative workplace built on trust and respect. We empower our people to take charge of their potential. We offer training and leadership development programs tailored to help you build valuable skills and succeed in your career. As you discover your potential, your professional and personal future will become brighter. Forward your CV / Resume : careers@cellixbio.com

REGULATORY AFFAIRS: Associate Director, CMC & Analytical Services Responsible for management analytical services and Chemistry, Manufacturing and Controls (CMC) function including, the development and maintenance of analytical and CMC related Quality Systems, identification, development and maintenance of contract labs, analytical method development/validation/transfer, Quality Assurance oversight of OOS investigations, analytical data review for raw materials, in-process materials and Finished Goods lot release testing, management of the stability program, and development. CMC Expert providing strategic direction and support to on-site manufacturing, Operations, R&D, Clinical and Commercial teams developing and commercializing products approved via NDA and PMA pathways. Expert knowledge of cGMP for finished pharmaceuticals. MSc / PhD in chemistry or chemical engineering with 5 - 10 years of experience.

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Job Detail

  • Job Id
    JD3028936
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Hyderabad, Telangana, India
  • Education
    Not mentioned
  • Experience
    Year