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Junior Manager -Biopharmaceutical Operations

6.00 to 9.00 Years   Kolkata   13 Apr, 2021
Syngene International Limited
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

Designation: Junior Manager, Biopharmceutical OperationsJob Location: Bengaluru, IndiaReporting to: Senior Manager, Biopharmceutical OperationsJob Grade: 8Operating Unit : BiopharmceuticalDepartment: Biopharmceutical OperationsThe CompanySyngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.The Role The 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 AreasRole-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 experienceOther 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
Equal Opportunity EmployerIt is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.Please visit us at https://syngeneintl.com/ to know more about us and what we do. ,

Keyskills :
equal employment opportunityrisk assessmentanimal healthquality systemdata managementcontinuous improvement facilitationsafetysaptroubleshootingcommissioningcgmp practicesconsumer goodsmechanical

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