Work as a Bioassay Team Leader - Quality Control @ Biocon
Job Description
Job purpose:
To manage a team of 15 people with previous experience in bioassays and molecular biology
To plan, execute and monitor cell based assay development activity, ELISA,PCR and Compliance in the lab
Planning and execution of method qualification, transfer and validation. Instrument qualifications; calibrations and other day to day activities .
Facilitating yearly budget and recruitment proposal for bioassay facility and molecular biology
Required skill set:
Experienced in method development related activities of in- vitro cell based assays like designing the experiments, writing the protocol and reports, execution of experiments, data analysis and evaluation. Latest understanding on the regulatory aspects of the USP and EP .
Hands on experience with mammalian cell lines, plate based cell assays, binding assays by flow cytometry or Biacore.
Experience in PLA software for determining the potency of the bioassay.
A thorough understanding of Analytical method validations and method transfers: review of protocol and report.
Experience in cGMP/cGLP working environment.
Experience in facing internal and external audits.
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