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Asst.ManagerDownstream

6.00 to 9.00 Years   Bangalore   08 Sep, 2019
Sygene
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process AnalysisStatistics / Analytics
EmploymentTypeFull-time

Job Description

Department: MSATPosition: Asst.Manager-Downstream (Microbial)Required Qualification and Experience: M.Sc with 9-12 years /M.Tech 6-9 yearsJob location: BangaloreRole Purpose:

  • To perform the activities related to MSAT function for downstream process technology transfer for microbial projects, deviation investigation, process trouble shooting, technical report writing and review batch records.
  • Understand technical instructions and execute downstream experiments as per the requirement, data analysis and interpretation.
  • Continuously monitor the manufacturing batches, collect, analyze and maintain the process data, perform trending and present.
  • Shop floor support as per technology transfer requirement
  • Discuss with Team Leader and other team members to assist in deciding and executing the action plans
TECHNICAL /FUNCTIONAL SKILL:
  • Execution of internal and external technology transfer initiatives.
  • Understand the facility constraint and provide shop floor support for technology transfer and scale up related activities.
  • Preparation of TTD and BMR review.
  • Author technical reports. Documentation includes gap analysis, risk assessment, statistical data analysis and other related technical reports.
  • Participate in planned and unplanned deviation investigation and perform/support related experimentation.
  • Trouble shooting of process/product related concerns.
  • Data collection/capturing, monitoring, trending and analyzing the data from cGMP campaign and authoring of summary reports.
  • Shop floor support for process validation and process characterization.
  • Coordination with cross functional teams.
  • Execution of laboratory experiments and documenting them in details in laboratory note book as per the requirement.
,

Keyskills :
statisticaldataanalysis continuousimprovementfacilitation gapanalysis dataanalysis riskassessment processvalidation technologytransfer scaleup gap bmr risk cgmp writing analysis hopflorep twriting

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