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Job Location | Hyderabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Education / Training |
Functional Area | Service / Installation / Repair |
EmploymentType | Full-time |
To execute and Operate Upstream manufacturing batch activities. To operate Process equipment like Single use Bioreactor, mixing systems, Filtration systems, Stainless steel preparation vessels, Cleaning in place vessels etc.Key Responsibilities: Execute all upstream manufacturing activities in the 2KL cell culture facility with disposable bioreactors.Execute batch in shake flask, Wave bioreactor, 100 L SUB, 500 L SUB and 2 KL SUB.Planning of raw material /consumables management for production campaign.Monitor batch process operation /unit operation (including CIP, SIP, media preparation, and upstream process accessories preparation)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 EHSS, cGMP and HRD. Follow environment, health, and safety (EHS) requirements always in the workplace ensuring individual and lab/plant safetyAttend training on environment, health, and safety (EHS) measures imparted companyEducational Qualification: Master s degree in BiotechnologyTechnical/functional Skills:Expertise in Upstream unit operations (CHO based mammalian expression systems).Handle mAb process for multiple products.Strong hands on experience with Single use bioreactor (up to 2000 L scale)Exposure of handling Bio-similar proteins and mAb projects in cGMP area.Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects.Experience on the Equipment Qualification and commission aspectsMust have basic information related to safety compliance (usage of PPEs etc.)Experience:3-6 years post qualificationBehavioral Skills:Should have the capability to work in a team and ability to handle demonstrate a good team spirit.While possessing a good ability to follow instruction should also demonstrate innovative in his/her approach, good communication skills.Should be proactive while working on allotted responsibility.,
Keyskills :
missalescustomer relationscustomer servicedeliveryequal employment opportunitycontinuous improvement facilitationcell cultureanimal healthconsumer goodspilot projectscgmp practices