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Sr. Principal Scientist

3.00 to 7.00 Years   Bangalore   08 Sep, 2019
Sygene
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

  • Hands on experience on upstream cell culture techniques
  • Experience in process scale up/scale down, risk assessment and statistical data analysis using tools like JMP, Stat-Ease etc.
  • Knowledge on facility fitment, process mapping will be added advantage.
  • knowledge upstream unit operations for large molecule is the must.
  • Preferred candidate should have worked on Mammalian cell culture derived mAb and/or non-mAb protein downstream purification.
  • Should be conversant with interpretation of analytical and process data.
  • Should be conversant with Scale-Up principles and have been involved in at least one scale-up related activity.
  • Proficient in handling of Single use and SS bioreactors, incubators etc and interpreting experimental results using standard tools.
  • Possess excellent communication and good writing skill and should be proficient in MS excel/word
Job Purpose:
  • To lead and ensure that activities related to MSAT function for technology transfer, scale up, deviation investigation, process trouble shooting, technical report writing as per guidance and other documents available in Syngene.
  • Provide technical instructions and upstream experiments as per the requirement, data analysis and interpretation of data along with feedback to manufacturing team/PD team.
  • Lead upstream part of internal and external technology transfer initiatives.
  • Preparation, review of TTD and BMR review.
  • Participate in planned and unplanned deviation investigation and perform/support related experimentation.
  • Understand the facility constraint and perform gap assessment, shop floor support for technology transfer and scale up related activities.
  • Author technical reports. Documentation includes gap analysis, risk assessment, statistical data analysis and other related technical reports.
  • Data collection/capturing, monitoring, trending and analyzing the data from cGMP campaign and authoring of summary reports.
  • Trouble shooting of process/product related concerns.
  • Represent USP technical team for client interactions and telecoms. Coordination with cross functional teams
,

Keyskills :
ap analysis process development continuous improvement facilitation statistical data analysis data analysis

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