Navaneeth B

Technical:

• ·Actively participate in Analytical method technology transfer and facilitate training implementation.
• ·Manage Quality Management System (QMS) aspects, including incident and out-ofspecification (OOS) investigations, and develop hypothesis testing plans.
• ·Collaborate on Chemistry, Manufacturing, and Controls (CMC) activities.
• ·Assist in drafting responses to regulatory queries.
• · Review of method validation protocol and report.

Team Management:

• · Lead Resource Planning: Manage a diverse team of 4 individuals with experience ranging from 0 to 6 years, ensuring optimal resource allocation.
• · Facilitate Team Development: Coordinate team appraisals and implement tailored training programs to enhance productivity and skill development.
• · Optimize Resource Allocation: Prioritize resource allocation to align with project deliverables and timelines effectively.
• · Ensure Operational Continuity: Strategically manage resources to maintain seamless operations and uphold cost efficiency across projects.

Technical:

·Validate methods and provide ongoing process support for quantifying process-related impurities such as residual host cell DNA (R-HCD), host cell proteins (HCPs), and leached protein A (LPA).

·Prepare method assessments and hypothesis testing plans to ensure robust analytical support.

·Actively participate in method technology transfer and facilitate training implementation.

·Successfully transferred analytical methods to Russian partners.

·Manage Quality Management System (QMS) aspects, including incident and out-of-specification (OOS) investigations, and develop hypothesis testing plans.

·Collaborate on Chemistry, Manufacturing, and Controls (CMC) activities.

·Assist in drafting responses to regulatory queries.

Team Management:

· · Lead Resource Planning: Manage a diverse team of 6 individuals with experience ranging from 1 to 8 years, ensuring optimal resource allocation.

· Facilitate Team Development: Coordinate team appraisals and implement tailored training programs to enhance productivity and skill development.

· Optimize Resource Allocation: Prioritize resource allocation to align with project deliverables and timelines effectively.

· Ensure Operational Continuity: Strategically manage resources to maintain seamless operations and uphold cost efficiency across projects.

· Developed methods for Flow Cytometry (FACS) to assess the binding activity of biomolecules to ligands.

· Developed methods and provided ongoing support for quantifying process-related impurities such as residual host cell DNA (R-HCD), host cell proteins (HCPs), and leached protein A (LPA).

· Contributed to stability and Biosimilarity studies of bio-molecules, utilizing cell-based assays and ligand binding assays for potency estimation.

· Proficient in utilizing Surface Plasmon Resonance (SPR) (Biacore 8K) to evaluate relative binding activity of bio-molecules.

· Actively participated in the implementation of Electronic Lab Notebook (ELN) for the Bioanalytics function within projects

• Method Implementation and develop new methods for characterization of Biomolecules (MABs)
• Regular analysis for testing of In-process, DS and DP samples for evaluation of charge variants, excipients.

• Develop and validate methods for quantifying residual host cell DNA (R-HCD), host cell proteins (HCPs), leached protein A (LPA), and Mycoplasma. Provide ongoing support for their quantification.
• Develop, validate, and routinely test DS and DP samples for excipient levels.
• Measure free thiol in products using a fluorometric assay.
• Support protein quantification during production with protein A chromatography.
• Analyze DS and DP samples for impurities using SEC.
• Analyze samples to support pharmacokinetic (PK) studies and assess immunogenicity in clinical trials.

Development of novel approaches for waste water treatment and renewable energy production (Biohydrogen, Biofuel cells, Biodiesel).