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Senior Associate Scientist, Biopharmaceutical Development MSAT

6.00 to 9.00 Years   Delhi   06 May, 2021
Sygene
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

Designation: Senior Associate Scientist, Biopharmaceutical Development MSATReporting to: Lead Scientist, MSATJob Grade: 8Operating Unit : BiopharmaceuticalDepartment: Biopharmaceutical Development MSATThe 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

  • To perform activities related to MSAT function for technology transfer for upstream (microbial), 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/Process Development team.
Key Result AreasRole-specific:
  • Perform internal and external upstream 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.
  • Ability to work in a team and willingness to work in shifts including night shiftsPossess 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 in BiotechnologyExperience6-9 yearsFunctional or Technical skills RequiredHands on experience on upstream microbial/mammalian process. 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 microbial and/or mammalian culture derived products. 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,

Keyskills :
auditingquality controlstatistical data analysismarketingequal employment opportunitybenefits administrationshop floorcontinuous improvement facilitationresearch

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