Syngene is inviting applications for the role of Senior Scientist – Analytical at its Bangalore location. This opportunity is in the Analytical department and is suitable for candidates with an analytical background in bioassay and physicochemical activities for large molecules, including monoclonal antibodies.

Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. The role involves development, validation, routine testing, documentation, and compliance-driven analytical laboratory work.

Job Details

Job Description

The selected candidate will be responsible for performing development, validation, and routine testing of bioassay/ELISA for Large Molecules (LMs), especially Monoclonal antibodies (mAbs) and other LMs. The role also includes method development, validation, and stability testing for drug substance and drug product. The candidate should be willing to work in shifts.

As per Syngene safety guidelines, employees are expected to follow safe practices, procedures, SOPs, data integrity requirements, health and safety measures, and quality standards at all times. The role also requires contributing to safe operations, EHS mindset, operational discipline, and compliance with company integrity and quality standards.

Key Responsibilities

• Develop and validate cell-based assays and binding assays such as ELISA for monoclonal antibodies.
• Perform drug content analysis by SEC and lower molecular weight distribution by Capillary electrophoresis for monoclonal antibodies.
• Troubleshoot problems related to bioassay, ELISA, SEC, and capillary electrophoresis methods.
• Handle instruments such as Microplate reader, HPLC, capillary electrophoresis, UPLC with Empower-3 software, UV Visible spectrophotometer, balances, Potentiometer, and stability chambers.
• Handle PMA instruments including PAMAS, APSS, HIAC…Etc.
• Follow good documentation and laboratory practices such as ALCOA+.
• Work on analysis of cell-based assays to derive relative potency using software such as Softmax Pro and PLA.
• Perform basic cell culture techniques and maintain mammalian cells, including adherent and suspension cell lines.
• Prepare Mammalian cell banks for Bioassays and work with primary and continuous cell lines including Revival, maintenance, cell bank preparation, and cryopreservation.
• Support calibration and qualification of Microplate reader, HPLC, Capillary electrophoresis, UPLC, and other QC laboratory instruments.
• Prepare and review raw data sheets, instrument operating procedures, and standard operating procedures.
• Handle QMS activities such as incidents, Out of Specifications, Deviations, and Change control through track wise platforms.
• Handle EDMS activities such as method development reports, validation protocols, validation reports, stability protocols, and stability reprots.
• Manage procurement and inventory maintenance of Pharmacopeial Standards, Chemicals, Reagents, Consumables, Spares, and other project requirements.
• Adhere to GxP, safety, and internal standard operating procedures.
• Use MS Office tools including word, excel, ppt, outlook, and other essential tools required for routine activity.
• Communicate with client/external users situated overseas through clear communication and e-mail writing.
• Review raw data for development, validation, calibration, and stability studies.

Qualification

• B.Sc
• M.Sc
• M. Pharm/ M. Tech/ M.Sc. / B.Sc. (Biotechnology)

Experience

Syngene is looking for an entry level lateral in Analytical background with experience in Bio assay and Physicochemical activities.

Required 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.
• Hands-on experience with Microplate reader, HPLC, UPLC/UHPLC, PAMAS, APSS, HIAC, Capillary electrophoresis, UV-Visible spectrophotometer, and other QC analytical instruments.
• Good documentation and laboratory practices such as ALCOA+.
• Experience in developing and validating SEC, CGE methods for mAbs.
• Ability to follow work instructions and perform tasks under the supervision of the Team leader.
• Preparation and maintenance of all documents.
• Good knowledge of MS-office including word, excel, and ppt.
• Good interpersonal skills, self-time management, team player attitude, and polite/good communication skills.

How to Apply

Interested candidates can review the official job details and apply online through the official Syngene careers page.

Candidates are advised to verify all details on the official application page before applying.

Author: PharmaBharat Editorial Team