Senior Analytical Development Manager

4 days ago

Vadodara, Gujarat, India beBeeAnalyticalDevelopment Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
">Senior Analytical Development Manager

We are seeking a highly skilled Senior Analytical Development Manager to lead our analytical development team.

The ideal candidate will be responsible for ensuring compliance with current regulatory guidelines and SOPs, aligning with the organization's goals, and performing calibration of instruments and maintenance of equipment according to SOPs.

Key responsibilities include method development studies for Drug Substance, Drug Product, and In-process Materials related to Peptides, as well as method validation studies for these same materials.

Additional duties include analysis of routine samples and stability studies for Drug Product, In-process Material, Drug Substance, and In-process Materials related to Peptides.

The successful candidate will also prepare Study Protocols and Study Reports, and analyze Oligonucleotides, DNA, RNA molecules, single-strand Sense and Antisense, and Duplexes molecules.

Furthermore, the Manager will develop IEX and Ion Pair methods for separating charge variants in DNA and RNA molecules, and SEC methods for separating size variants in DNA and RNA molecules.

Isolation of peptide molecules from impurities by PREP HPLC is also a key responsibility.

In this role, you will have the opportunity to work on complex projects, collaborate with cross-functional teams, and contribute to the success of our analytical development team.

">Responsibilities:
  • Ensure compliance with current regulatory guidelines and SOPs
  • Perform calibration of instruments and maintenance of equipment according to SOPs
  • Develop and validate methods for Drug Substance, Drug Product, and In-process Materials related to Peptides
  • Analyze routine samples and stability studies for Drug Product, In-process Material, Drug Substance, and In-process Materials related to Peptides
  • Prepare Study Protocols and Study Reports
  • Analyze Oligonucleotides, DNA, RNA molecules, single-strand Sense and Antisense, and Duplexes molecules
  • Develop IEX and Ion Pair methods for separating charge variants in DNA and RNA molecules
  • Develop SEC methods for separating size variants in DNA and RNA molecules
  • Isolate peptide molecules from impurities by PREP HPLC
Requirements:
  • Bachelor's degree in Chemistry or a related field
  • 5+ years of experience in analytical development
  • Strong understanding of cGMP regulations and SOPs
  • Excellent communication and leadership skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks
  • Experience with instrument calibration and maintenance
  • Knowledge of HPLC and mass spectrometry techniques
  • Familiarity with laboratory safety procedures

If you are a motivated and experienced professional with a passion for analytical development, we encourage you to apply for this exciting opportunity.

We thank all applicants for their interest; however, only those selected for an interview will be contacted.

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