Job Posting: Analytical – Large Molecules (SEC+CGE)
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.
- 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
- Good Interpersonal skills
- Self-time management
- Good Team player
- Polite/Good Communication skills
All employees will consistently demonstrate alignment with our core values:
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)
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