Urgent requirement for Executive or Senior Executive 1

Job Title Executive Senior Executive Job Location Bangalore Job Grade + +I +II About Syngene Syngene www syngeneintl com is an innovationled contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and SOPs in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures practices and systems that ensures safe operations and compliance to company s integrity quality standards Driving a corporate culture that promotes environment health and safety EHS mindset and operational discipline at the workplace at all times Ensuring safety of self teams and lab plant by adhering to safety protocols and following environment health and safety EHS requirements at all times in the workplace Ensure all assigned mandatory trainings related to data integrity health and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role Responsible to perform the development validation and routine testing of bioassay ELISA for Large Molecules LMs especially Monoclonal antibodies mAbs and other LMs Role Accountabilities Shall develop and validate cellbased assays and binding assays ELISA especially for monoclonal antibodies mAbs etc Shall troubleshoot the problems with bioassay methods Must have strong knowledge of the development of cellbased bioassays for Monoclonal antibodies Experience in Qualification and Validation of cellbased bioassays Broad knowledge on analysis of cellbased assays to derive relative potency software s such as Softmax Pro and PLA Basic cell culture technics and handson experience in maintaining of mammalian cells Must have experience in handling various cell lines adherent and suspension cell lines Preparation of Mammalian cell banks for Bioassays Experience in handling of primary and continuous cell lines like Revival maintenance cell bank preparation and cryopreservation Shall prepare the raw datasheets protocols reports and SOPs Handling of QMS Incidents deviations change controls etc for GMP activities Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards Chemicals Reagents Consumables Spares etc required for the projects Shall adhere to the procedure of GxP GMP Safety and as per the procedure defined in the internal standard operation procedure Must have good hold on MS office word excel ppt outlook and other essential tools required for routine activity Good communication and email writing skills are required since the candidate needs t communicate with clients external users situated overseas Commitment to safety Behavioral Skills Good Interpersonal skills Team Time management Relationship management Internal External Innovative thinking Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 36 years Skills and Capabilities Shall have experience in development validation and routine testing of Bioassay ELISA especially for Monoclonal antibodies mAbs and other Large molecules Qualification and validation of cellbased bioassays Able to follow instructions and perform the tasks under the supervision of the Team leader Preparation and Maintenance of all the documents Good knowledge of MSoffice word excel ppt Should have good communication and Email writing skills Education M Pharm M Tech M Sc B Sc Biotechnology Biochemistry