Lipika (Ph.d.) B.
Associate Director, Analytical Sciences and Technology
Experience
Associate Director, Analytical Sciences and Technology
Immunovant Inc.
- Lead QC analytical methods validation, method transfer, bridging and comparability studies.
- Providing scientific guidance on data analysis and interpretation, trending analysis, contributing to the preparation of regulatory submissions and technical reports.
- Coordinate with members of Process Analytical Sciences, Manufacturing, Stability, and Business Ops to provide analytical support to cross-functional groups and CMOs/CROs.
- Oversee investigations of atypical and OOS test results as necessary and implement CAPA as needed.
- Review various tech documents for regulatory submissions.
- Author/review/approve reference standard qualification and extension.
- Author/review/approve protocols and reports for phase appropriate acceptance criteria and specification settings.
- Own development of current and long-range plans and objectives required to assure quality and regulatory compliance.
Associate Director, QC Analytical Transfer
Allakos
- Devised and transferred analytical test methods for GMP manufacturing campaigns.
- Lead activities for phase appropriate release, stability specifications and comparability studies.
- Implemented two tier Reference Standard Program (implemented supporting SOPs).
- Oversaw test method development and validation/qualification of process impurities.
- Worked with contract labs on various method development, transfer, validations and trouble shootings.
- Represented QC and analytical group in CMC meetings and prepared documents for regulatory submissions.
- Left Allakos as company started to have financial challenges (ultimately ceased operations Jan 2025).
Principal Scientist, QC Technical Services
Nestle Health Science
- Lead activities focused on the development and assessment of product specifications, monitor product quality and performance, and study designs.
- Remotely managed Global CMOs and contract testing labs.
- Drove method lifecycle projects, gap assessments, and mitigation plans.
- Left Nestle prior to group being dissolved after re-organization.
Control Strategy Scientist
Genentech Inc. / Roche
- Developed quality control strategy and led matrix teams in lifecycle management of various commercial products.
- Establish/manage specifications (IPC, release and stability) throughout lifecycle.
- Lead product comparability and stability study designs for process changes/tech transfers.
- Prepare regulatory filing documents and address regulatory questions related to analytical methods, method validation, justification of specification, comparability, and critical quality attribute(s) determination.
- Support internal audits and external inspections.
- Provide technical oversight for internal QC testing sites and CMOs, method validation, method monitoring and reference standard qualification/stability.
- Provide technical assessment for discrepancies (e.g., OOT, OOS, temperature excursions).
- Key contributor to Pharmaceutical Quality System activities (change control, APQR etc.).
- Provide oversight into transfer and co-validation of new analytical methods.
- Drive implementation of new technologies across multiple QC testing sites.
- Lead the cross functional team for the global implementation of key excipient (polysorbate 20).
- Conducted test failure investigations within the Quality Control laboratories.
- Provided technical support and training on laboratory instrumentation.
- Perform BLA validation experiments for commercial launch of mAb product (multiple analytical methods including SE-HPLC, IE-HPLC, CE-SDS, HILIC glycan, peptide mapping).
- Designed overall comparability strategy for the introduction of a new drug product manufacturing site (at CMO) for a lyophilized product.
Associate Scientist
ThermoFisher Scientific
- Designed/developed solutions enabling ThermoFisher’s product success with a diverse set of customers.
- Responsible for providing complete end-to-end customer solutions across a broad range of industries: food, manufacturing, utilities, pharma etc.
- Developed application with enhanced sensitivity which enabled analysis of chromate at proposed Public Health Goal level in drinking water. Water analysis accounted for 1/3 of sales for business unit.
- Collaborated with NREL to develop fast (<10 min) and robust method for the analysis of complex biomass samples.
- Supported sales and service organization in multiple markets, including the food and pharmaceutical industries. Troubleshoot issues at customer sites.
- Author Application Notes. Communicated these methods through peer-reviewed journals, scientific conferences, and trade journals.
Scientist
Trinity Biosystems
- Formulation development for oral and intra-nasal delivery of therapeutics.
- Analytical method development for analysis of carrier protein, linker peptide and therapeutic payload.
- Left as company faced financial challenges.
Post-Doctoral Fellow
Genentech Inc.
- Directed research on oxidation in bio-therapeutics and fate of radicals in hydrogels.
- This study is the first report investigating the application of EPR spectroscopy in detecting and estimating free radical concentration in cellulose-based hydrogels (J. of Pharm Sc, Vol. 98, No. 7, July 2009).
Post-Doctoral Fellow
Scripps Research Institute
Graduate Research Assistant
Stanford University
Summary
With 20+ years of industry experience, I have demonstrated expertise in quality control and analytical science support for clinical and commercial manufacturing, for therapeutic monoclonal antibodies and proteins. My responsibilities have included overseeing and leading the validation and transfer of QC methods, conducting bridging, physiochemical characterization, and comparability studies. I have extensive knowledge of various analytical methods, such as HPLC, IEC, HIC, icIEF, CE, SEC, and safety tests. I have provided complete end-to-end customer solutions across a broad range of industries: manufacturing, utilities, pharma, food, etc.
I excel in generating, reviewing, and approving controlled and technical documents, such as test methods, stability protocols, validation reports, and characterization/comparability reports. I have demonstrated expertise in the design and authorship of test methods, analytical and process validation protocols/reports, technical transfer protocols, release and stability specifications, SOPs, root cause investigations, statistical trend analysis, change controls and CAPAs. I have maintained cGMP compliance in QC labs and cGMP training to staff members. Additionally, I have a proven track record in efficiently managing CRO and CMO projects related to analytical and QC testing. I have effective communication and collaboration skills to work with cross-functional teams and external vendors to meet aggressive timelines.
Languages
Education
Stanford University
Ph.D. · Chemistry · Stanford, United States
Indian Institute of Technology, Kanpur
MS · Kanpur, India
Indian Institute of Technology, Kanpur
BS · Kanpur, India
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