Urgent requirement for Executive or Senior Executive 1

Job Description

Job Title: Executive/Senior ExecutiveJob Location: BangaloreJob Grade: 9 (9-I/9-II)About Syngene: Syngene (www.syngeneintl.com) is an innovation-led 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 spiritMandatory 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 cell-based 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 cell-based bioassays for Monoclonal antibodies.
• Experience in Qualification and Validation of cell-based bioassays
• Broad knowledge on analysis of cell-based assays to derive relative potency software s (such as Softmax Pro and PLA)
• Basic cell culture technics and hands-on 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 e-mail 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 ValuesAll employees will consistently demonstrate alignment with our core values
• Excellence
• Integrity
• Professionalism
Specific requirements for this roleExperience
• 3-6 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 cell-based 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 MS-office (word, excel, ppt)
• Should have good communication and E-mail writing skills
Education
• M. Pharm/ M. Tech/ M.Sc. / B.Sc. (Biotechnology/Biochemistry)
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Keyskills :
miscustomer relationswriting skillssalescell linesms officeqms