ARYA M NAIR

Initial Career:

Job Role: Executive

Work Experience:

Ø Experience of working on Stratagene Mx3005p (QPCR) and had done validation for a Host Cell DNA (HCDNA) method for CHO and NS0 cells of QPCR for a Monoclonal Antibody.

Ø Hands on experience for ELISA for detection of Protein A and Host cell Proteins for CHO cells for a Monoclonal Antibody.

Ø Experienced in execution of techniques such as

· SDS-PAGE

· Iso-Electric Focusing (IEF)

· Western Blot and Lowry’s method for estimation and quantification of proteins.

· Capillary Electrophoresis [CE] for the purity analysis of therapeutic monoclonal antibody.

Current Role: Deputy Manager

Current Key works:

Ø Analytical method transfers, Method Validation

Ø Reference standard Management in Quality Control

Ø Development and Implementation of a two tier reference standard strategy in quality control.

HandlIngof QMS elements related to Bioanalytical techniques

Work Experience:

Ø Expertise in handling of QMS elements change controls, deviations, OOS, CAPA.

Ø Experienced in cell bank characterization and bulk harvest testing [viral testing]

Ø Experienced in review of test results obtained from CTL [Contract Testing Lab] for viral testing

Ø Reference standard Management in quality control, involving the filling and qualification of the reference standards, Reconciliation and management of the reference standard usage in quality control lab.

Ø Experienced in handling of In-Process, Finished product and stability samples for testing sample

Ø Executed viral testing facility audits on external companies

Ø Experienced on Method development, analytical method validations, method qualifications, Phase I, Phase III manufacture of monoclonal antibodies.

Ø Trained and experienced on handling of investigations such as deviation, OOS, change control in quality control

Ø Experience in preparation and execution of the study protocol and reports for studies executed in quality control.

Ø Experienced in preparing of product specifications, SOPs, technical documents

Ø Experienced in preparation of product trends at various stages of product at In-process stage.

Responsibilities executed:

· Executed a role as Team leader in Molecular Biology with a team strength of techniques for the release of batches manufactured in facility

Achievements:

• Played a key role in the launch of the major Biosimilar drugs: Itolizumab and Canmab at Biocon Biologics Limited.
• Active participant in the development of the Biosimilars like Adalimumab, Bevacizumab
• Worked towards establishing and maintaining quality standards and developed new standards for continued quality improvement
• Developed and participated in the quality auditing process for the plant (Internal and External).
• Developed, maintained and improved forms, documents, SOP’s and reports.
• Successful completion of process validations (Analytical method validations and Equipment validations).
• Review of Technology transfer documents, Analytical method validations as per the existing guidelines.
• Established a standard review program to evaluate documentation and improve and/or create where ever necessary.
• Part of regulatory audits [FDA, EMEA, Health Canada, DCGI ,Anvisa- Brazil, MoH audits] and other quality audits. Developed and Implemented corrective actions.

Ø Training Programs completed on

· Stratagene Mx3005p (QPCR)

· Host Cell DNA (HCDNA) for CHO and NS0 cells of QPCR for a Monoclonal Antibody.

· ELISA for detection of Protein A

· Host cell Proteins for CHO cells for a Monoclonal Antibody.

· SDS-PAGE

· Iso-Electric Focussing (IEF)

· Western Blot

· Lowry’s method for estimation and quantification of proteins.

Capillary Electrophoresis [CE] for the purity analysis of therapeutic monoclonal antibody.

Completed a training programs on Moleclar biology