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Job Posting: Analytical – Large Molecules (SEC+CGE)

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.

Job Role: Analytical – Large Molecules (SEC+CGE)

Department: Analytical – BGRC

Job Location: Bangalaore

Requisition ID: 55611

Core Purpose of the Role

The candidate shall be responsible for method development, validation, and stability testing of drug products of Large molecules/Small molecules in GMP environment. The candidate shall be willing to work in shifts. Hands-on experience on working with CGE (Capillary Gel Electrophoresis), SEC (Size Exclusion Chromatography) for Large Molecules (LMs), especially Monoclonal antibodies (mAbs) and other LMs.

Role Accountabilities

  • Must have strong hands-on experience in development and validation of Assay & related substances methods for small molecules for different formulations (Preferably for Parenterals such as liquid, Lyophilized, and Dry powder formulations)
  • Must have experience in handling HPLC, UPLC (Empower-3 software), UV Visible spectrophotometer balances, pH meter, PMA and stability chambers
  • Shall have experience on Good documentation/laboratory practices such as ALCOA+
  • Experience in developing and validating SEC, CGE, GC methods is an added advantage
  • Experience in calibration and qualification of HPLC, UPLC, and other laboratory instruments
  • Shall prepare and review the raw data sheets, instrument operating procedures, and standard operating procedures
  • Shall have good experience in handling of QMS (such as incidents, Out of Specifications, Deviations, and Change control)
  • 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/Safety and as per the procedure defined in the internal standard operation procedure
  • Shall operate the 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 to communicate to client/external users situated overseas

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: 3-6 years

Skills and Capabilities

Hands-on HPLC, UPLC/UHPLC, Capillary electrophoresis, UV-Visible spectrophotometer, PMA and other analytical instruments. Experience in developing and validating SEC, CGE, GC methods is an added advantage. Theoretical knowledge in Chromatography and spectroscopy technique. Good documentation/laboratory practices such as ALCOA+. Able to follow work 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). The candidate must have willingness to work in shifts and in QC or GMP AD environment based on the emerging business needs.


M. Pharm /M. Sc with 3-6 years’ experience in GMP environment (QC)

Link to Original Notification to apply

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