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Junior Manager -Biopharmaceutical Operations

6.00 to 9.00 Years   Delhi   05 Mar, 2021
Sygene
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

Designation: Junior Manager, Biopharmceutical OperationsThe role is responsible to supervise Upstream manufacturing process at Syngene s new manufacturing facility for recombinant Microbial products (E-coli and yeast), up to 200L-500 L scale process. Key Result Areas Role-specific:

  • Supervise all upstream manufacturing activities in 200L -500L upstream & mid-stream (till IB)
  • Manage the team and plan daily upstream execution activities.
  • Active trouble shooting to minimize the various risks prior to execution and during execution.
  • Drive the process upstream deviations /investigations and closure.
  • Planning of raw material /consumables management for production campaign.
  • Drive Upstream process execution: Batch process operation /unit operation (including CIP, SIP and preparation upstream accessories), close monitoring of batch performance and data.
  • Follow and practice on-line documentation all the time.
  • Follow cGMP practices during the manufacturing activity and operations associated activities with QA, QC and EAM.
  • Attend the training session of EHS, cGMP and HRD.
  • Ensure process equipments/instruments are in Qualified in state.
  • Active coordination with inter-depts. for sample submission, closure of documentation and timely execution and contribution for the assigned tasks.
  • Supervise on-line documentation, cGMP compliance in all the manufacturing activity, and timely closure of executed documents and batch records.
  • Ensure the Quality system is followed in day today upstream operations. Identify the gaps in the system to improve.
  • Target error free operation by eliminating operational gaps in advance.
  • Active trouble shooting to minimize the various risks prior to execution and during execution.
  • Possess the knowledge and exposure to Environment, Health, Safety, and Sustainability (EHSS) practices.
  • Follow Environment, Health, Safety, and Sustainability (EHSS) requirements at all times in the workplace ensuring individual and lab/plant safety.
  • Attend training on Environment, Health, Safety, and Sustainability (EHSS)
Education and Experience EducationMaster s degree in Chemistry Industry Experience 6-9 years of relevant experience Other competencies required for the role
  • Expertise in upstream unit operations (E-coli and yeast).
  • On job experience in microbial process at manufacturing scale
  • Strong Hands on experience with SS Fermenters and associated controls
  • Exposure to handle of Bio-similar proteins handling in cGMP area
  • Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects.
  • Experience on risk assessment tools and change management
  • Experience on the Equipment Qualification and commission aspects
,

Keyskills :
commissioningsafetysapcontinuous improvement facilitationcgmp practicesmechanicaltroubleshootingequal employment opportunityconsumer goodsanimal health

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