Sun Pharma Hiring For Senior Executive / Manager
Position : Senior Executive / Manager 2
Work Location: Tandalja - R&D
Company: Sun Pharmaceutical Industries Ltd
Key Responsibilities:
Analytical Method Development & Validation Develop and validate robust HPLC methods for characterization and quantification of biological products (e.g., monoclonal antibodies, recombinant proteins).
Perform method optimization, robustness studies, and transfer protocols as per ICH guidelines.
Capillary and Gel Electrophoresis
UV spectrophotometric methods
Host Cell DNA quantification (e.g., qPCR-based methods)
HCP ELISA and other immunoassays
Instrument Operation & Maintenance
Ensure timely qualification and performance verification of instruments.
Documentation & Compliance
Maintain accurate and complete documentation in laboratory notebooks and electronic systems.
Quality & Regulatory Compliance
Cross-functional Collaboration
Provide technical support during investigations, deviations, and CAPAs.
Training & Development
Stay updated with advancements in analytical technologies and regulatory expectations.
Qualifications & Experience:
4–8 years of relevant experience in analytical development or QC of biopharmaceuticals.
Key Skills:
Attention to detail and data integrity
Position : Senior Executive / Manager 2
Work Location: Tandalja - R&D
Company: Sun Pharmaceutical Industries Ltd
Key Responsibilities:
Analytical Method Development & Validation Develop and validate robust HPLC methods for characterization and quantification of biological products (e.g., monoclonal antibodies, recombinant proteins).
Perform method optimization, robustness studies, and transfer protocols as per ICH guidelines.
Routine & Stability Testing
Conduct analysis of in-process, release, and stability samples using:
HPLC/UPLC
Capillary and Gel Electrophoresis
UV spectrophotometric methods
Host Cell DNA quantification (e.g., qPCR-based methods)
HCP ELISA and other immunoassays
Instrument Operation & Maintenance
Perform routine maintenance, calibration, and troubleshooting of analytical instruments including HPLC, electrophoresis systems, spectrophotometers, and ELISA readers.
Ensure timely qualification and performance verification of instruments.
Documentation & Compliance
Prepare and review SOPs, STPs, protocols, reports, and analytical records in compliance with regulatory requirements.
Maintain accurate and complete documentation in laboratory notebooks and electronic systems.
Quality & Regulatory Compliance
Participate in internal and external audits, and support regulatory submissions with analytical data.
Cross-functional Collaboration
Work closely with R&D, Quality Control, and Regulatory Affairs teams to support product development and lifecycle management.
Provide technical support during investigations, deviations, and CAPAs.
Training & Development
Train junior analysts and new team members on analytical techniques and laboratory practices.
Stay updated with advancements in analytical technologies and regulatory expectations.
Qualifications & Experience:
M.Sc. / M.Tech / M.Pharm in Biotechnology, Biochemistry, or related life sciences discipline.
4–8 years of relevant experience in analytical development or QC of biopharmaceuticals.
Hands-on experience with HPLC method development and ELISA based techniques.
Familiarity with regulatory guidelines (ICH, FDA, EMA) and quality systems.
Key Skills:
Strong analytical and problem-solving skills
Attention to detail and data integrity
Excellent documentation and communication abilities
Proficiency in software tools like Empower, Chromeleon, SoftMax Pro, etc.
Ability to manage multiple projects and meet deadlines
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