Position
AD/QC - Head
Description

We are looking for people who share our passion for technological excellence and have process development capabilities with proven leadership qualities to oversee upstream process vertical in a competitive biotech environment.

Responsibilities
  • Responsible for characterization and lot release assays of Biologics
    (intermediates, Drug substance and Drug product) using orthogonal methods,
    with different equipment skills (Analytical, Microbial and Biological)
  • Preparation/Review/Revise of SOPs, STPs and data recording sheets
  • Stability study protocols, method development protocol, qualification &
    validation protocols and respective reports
  • To ensure that processes are followed as per ISO and GLP
  • Carries out duties in compliance with local, state and CDSCO/RCGM
    regulations and international guidelines including USFDA and EMA
  • Executes the Development, Qualification / validation of analytical methods
  • Maintains detailed records in compliance with applicable GLP, safety and
    environmental requirements
  • Provide technical reports, tech transfer documents, and prepare scientific
    presentations as needed. Write/revise SOPs when required
  • Collaborate and coordinate with colleagues from all other groups
  • Participate in technology transfer to external collaborators and partners
  • Schedules, mentors, trains and supervises the quality control staff
  • Problem solving and finding alternative solutions, smart ways to handle issues
    and come to logical conclusions

 

Preferences:

  • Having complete knowledge on monoclonal antibody analysis and
    characterization
  • Having experience in method tech transfer to CMO/CRO
  • Preparing CMC dossier, IND application for NME (Biologics)
  • Immuno-onco product experience is added advantage

Apply now

Position: AD/QC - Head

Thank you for submitting your application. We will contact you shortly!

Date posted
July 3, 2019
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