Senior Research Associate- AS (Biologics) -Biosimilars (Reviewer)

Join a globally recognized CRO and be part of cutting-edge research and work with advanced technologies, and contribute to high-impact pharmaceutical innovation

Department:

Position:

Location:

Qualifications:

• M.Sc. / M. Pharm / M.Sc. in Biotechnology or Equivalent Qualification
• 6-8 years of relevant experience in the pharmaceutical industry or CRO environment.
• Proficiency in mass spectrometry and chromatographic techniques for biologics.
• Knowledge of cGMP/GLP and instrument qualification processes.
• Strong communication and independent working skills.

Roles and Responsibilities

• The laboratory scientist will be responsible to organize, conducts and documents demanding scientific experiments/testing by analytical techniques like HPLC/UPLC, LC-MS, UV, CD, Capillary electrophoresis, SEC-MALS, and other analytical techniques.
• Experience in the areas of Monoclonal Antibodies, Biosimilar, Peptide, Therapeutics proteins and complex drug molecules.
• Reviews and verifies raw data generated from analytical instruments.
• Review of calibration of respective instruments, standard operating procedures, method of analysis, protocols, and Reports.
• Review of chromatograms, laboratory notebooks, electronic data, SOPs and other relevant documents and creation of custom fields for respective softwares and review of audit trails as per the required software.
• Review of qualification documents of instruments related to Biologics lab.
• To maintain GLP & safety procedures while working in the laboratory and coordinate with other team members as per the requirement.
• Conduct analytical method development, validation and verification to ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams to resolve analytical issues and improve process efficiency.
• Maintain accurate records of laboratory experiments, results, and reports according to GLP guidelines.
• Ensure compliance with ICH, FDA, and EMA guidelines.
• Participates in ensuring operational excellence in the laboratory.

Interested candidates can share an updated CV with hr@chiral.daice.com or Via WhatsApp to 7207760479