Incorporated in the year 1994, Syngene International is one of India€™s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies and has received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP and AAALAC.
Vacancy Details
- Role: Junior Manager/Assistant Manager
- Qualification & Experience: MPharm/ MTech/ MSc/ BSc (Biotechnology/Biochemistry)
- Experience: 06-09 Years
- Location: Bangalore
Details as below:
◆ MPharm/ MTech/ MSc/ BSc (Biotechnology/Biochemistry) with 6-9 years
https://loom.ly/C3XSLB0
Last date to apply: 25th Jan 2023
Please apply on the above links or write to Jharana.das@syngeneintl.com for more details.
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 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 Values
All employees will consistently demonstrate alignment with our core values
• Excellence
• Integrity
• Professionalism
Specific requirements for this role
Experience 6-9 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
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