Title:  Bioassay Analyst - Large molecules

JOB DESCRIPTION

Job Title: Bioassay Analyst - Large molecules

Job Location: Bangalore

Department - BGRC Analytical

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 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:

• The candidate shall be responsible to perform the development, validation, and routine testing of bioassay/ELISA for Large Molecules (LMs), especially Monoclonal antibodies (mAbs) and other LMs. The candidate shall be responsible for method development, validation, and stability testing drug substance/drug product. The candidate shall be willing to work in shifts.

Role Accountabilities:

• Shall develop and validate cell-based assays and binding assays (ELISA), SEC and CGE especially for monoclonal antibodies (mAbs), etc. Shall troubleshoot the problems for these methods.
• Must have strong knowledge of the development of cell-based bioassays for Monoclonal antibodies.
• Experience in Qualification and Validation of cell-based bioassays
• Shall have experience on Good documentation/laboratory practices such as ALCOA+
• 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, Out of Specifications, 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
• Experience in developing and validating SEC, CGE methods is an added advantage especially for monoclonal antibodies (mAb) is an added advantage
• Experience in calibration and qualification of HPLC, UPLC, GC, and other QC laboratory instruments is added advantage
• Good communication and e-mail writing skills are required since the candidate needs to communicate with clients/external users situated overseas
• Commitment to safety

Behavioral Skills

• Good Interpersonal skills
• Self-time management
• Good Team player
• Polite/Good Communication skills

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

Experience

• 2-6 years

Skills and Capabilities:

• Development, validation, and routine testing of Bioassay /ELISA, SEC, CGE 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
• Experience in developing and validating SEC, CGE and HPLC methods for mAbs is an added advantage
• Theoretical knowledge in Chromatography and spectroscopy technique
• Good documentation/laboratory practices such as ALCOA+
• Good knowledge of MS-office (word, excel, ppt) and E-mail writing skills

Education

• M. Pharm/ M. Tech/ M.Sc. / B.Sc. (Biotechnology/Biochemistry) with 2-6 years' experience in GMP environment (QC)