Manager - Analytical Development

ConfidentialVadodara, India

6 days ago

Job description

To work as per cGMP and ensure its compliance as per current guideline and SOPs.

Responsible to align with organization goal and other responsibilities assigned by reporting authority.

Responsible to perform the calibration of instrument and to maintain instrument / equipment as per SOPs.

Responsible to follow safety precaution as per laboratory procedure.

Responsible for method development studies of Drug Substance, Drug Product & In process Materials related to Peptides.

Responsible for method Validation studies of Drug Substance, Drug Product & In process Materials related to Peptides.

Responsible for analysis of routine samples and stability studies of Drug Product & In process Material Drug Substance, Drug Product & In process Materials related to Peptides.

Responsible to prepare Study Protocol and Study Reports.

Responsible for analysis of Oligonucleotides (DNA & RNA molecules) of single strand (Sense and Antisense) and Duplexes molecules.

Responsible for Development of IEX and Ion Pair method for Sense and Antisense to separate charge variants in DNA and RNA molecules

Responsible for Development of SEC method to separate size variants in DNA and RNA molecules.

Responsible for Isolation of Peptide molecules from impurities by PREP HPLC.

Skills Required

Method Validation, stability studies , Cgmp, Method Development

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Development Manager • Vadodara, India

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