Mahender R Alluri, Ph.D. Email and Phone Number

Provide Pharmaceutical Consulting Services in the area of Quality Systems - Analytical Testing GMP lab setup /manage, Analytical method validation and assessment of test methods, Equipment qualifications, quality technical services addressing FDA-483 issues as well as assistance in development and implementation of associated quality management systems such a LIMS, empower administration, SDLC implementation. This also includes GMP Laboratory Operations, Analytical Methods (Development, Validaition, and transfer), Data Review & Specifications Justification, Stability, CMC Submissions & Health Authority Responses, Audits and Inspections, Annual Product Reviews, Investigations/CAPAs, Product Quality Complaints, Documentation Control, Training, Change Control.

Black Diamond Network Consultant:Served as Senior Quality Compliance Investigator, prepared lab investigation reports, performed Gap Analysis on Quality systems for Biological products, assisted site management in the preparation for FDA Readiness for PAI. eLIMS and Comet software used for tracking deviations, investigations, CAPA plan implementation.

Black Diamond Network Consultant:Served as Senior Quality Compliance Investigator, prepared lab investigation reports, performed Gap Analysis on Quality systems for Biological products, Veeva Vault, eLIMS software used for tracking deviations, investigations, CAPA plan implementation.

Takeda Pharmaceuticals, Lexington, MA Feb to Present 2022 Parexel Senior Consultant: Lead Scientist and Subject Matter Expert (SME) for technical support for QC Raw Material Testing Lab on method transfer projects, method verification and Validation, Risk Assessments for Analytical testing methods used for testing Biological (cell culture and media testing) and pharmaceutical products (compendial USP/EPJP and non-compendial).

GMP and Regulatory compliance - Worked on projects related to Remediation, BRR, Injectable products 3rd party oversite verifications Deviations and investigations.

Actively involved in the global Pharmaceutical projects (USA , Europe and India) that deals with Quality Systems Compliance, Remediation and Rebuilding, Provide Technical support, review technical documents and prepare response to FDA 483 observations and Warning Letters. Lead and complete the projects as per proposed timelines, enhance the Quality and GxP activities at the Global Sites.

Work on International Consulting assignments Europe/India, Review/Audit- Batch Records, Method Validation Reports and raw data, identify gaps based on the current MV requirements per FDA/USP/ICH guidelines. Review and verify - Data Integrity. Prepare protocols/reports for the method validation and Method transfer, CAPA plans to address remediation activities.

Independent Senior Quality System Consultant, Report to Senior Management, provide strategic and technical support to DMPK-GLP Lab: Responsible for performing activities and project management to support the remediation and Base Business. analytical methods and validation of test methods, qualification of instruments and validation of lab facilities, GLP and GMP plan & Quality system strategy development. Advise the team to setup New GLP lab, and provide support to implement Quality Systems such as SOP updates and harmonization of site procedures as needed. Track and update Remediation project progress as per proposed schedule.

Consultant - Project Manager - Lead a team to setup New GMP Stabilty lab, and implement Quality Systems such as SOP updates and harmonization of two site procedures (Suffern and East Hanover sites). As per regulatory compliance and 21 CFR Part-11 requirements - Qualify and validate the various types of Analytical instruments, setup network and update to empower 3 on Waters HPLC systems, Validate Facilities such as Stability Chambers and glassware units, Waters system units to meet USP requirements. Decomission old instruments, Relocate and requalify instruments. Managed about 20 million budget, Identify and purchase new instruments and coordinate qualification and validation activities with various vendors and lab analysts, Track and update validation project progress for about 100 new instruments and 20 products on stability program to meet the timeline as per proposed schedule.

• Provided analytical support to Global Science and Technology Commercialization- Merck Manufacturing Division for in-line products, customer complaint investigations, and counterfeit investigations, MMD-reference standard program. Support to Network activities – method development, validation, and method transfer activities. • Managed the Equipment Maintenance project for about 200 instruments at ACDS-SAS lab, written SOPs, protocols and qualification reports, maintained the instruments at qualified state through its life cycle. Due to merger of SP with Merck, and closure of Union site, Championed the relocation of instrument activities from Union to summit. Successfully relocated about 200 instruments, Re-qualified /calibrated the instruments. Actively participated in setting of new GMP lab as per 5S criteria at Summit facility.• Provided LCMS and GCMS analytical support to unknown peak identifications in the APIs and finished products.• Actively involved in the SOP harmonization project, and in the Lab GMP audits. Provided responses to audit observations, closed CAPAs, enhanced gmp compliance and lab efficiency.

• 3 years worked as Associate Principal Scientist and provided analytical technical support for European Union Harmonization activities – Analytical technical team for responses and CMS activities related to commitments and remediation plans.• Managed Equipment Maintenance project for about 400 instruments at ACDS-AS lab, written SOPs, protocols and qualification reports, maintained the instruments at qualified state through its life cycle. • Calibrated HPLC, GC, IR, UV/VIS spectrophotometers, dissolution apparatus, GCMS, LCMS systems.• Managed department SOPs, GMP lab, housekeeping and safety.• Received Appreciation awards during 2007 and 2008, through Schering Plough Shining Performance program for outstanding leader behaviors: Shared Accountability and Transparency, Cross-Functional Teamwork and Collaboration, Benchmark and Continuous Improvement.

• 4 years worked as a Manager /Team Leader for the Analytical Methods Validation Assessment project that involved evaluation of various test methods used for testing NJ, LPO and Manati (PR) products (APIs and Finished products). • Prepared Protocols, Analytical Methods Validation Assessment and Analytical Equipment Assessment reports to support VCP work. Played a key role in the successful completion of CD-VCP work for about 30 products. • Received a congratulation award during 2005 for the completion of CD-VCP project.• Coordinated remediation efforts at the sites (NJ and Manati) to fill the analytical gaps associated with MV work.• Actively interfaced with 3rd party reviewers (Quantic Regulatory services and Lockmann) and interacted with site QA/QC/ Regulatory departments to resolve the analytical and regulatory issues in a timely manner. • Managed GQS-AS Lab Analytical Equipment Maintenance Program. Successfully implemented the Value Enhanced Initiative (VEI) program to reduce the service cost and improve the Lab efficiency.

• Supervised analysts and managed multiple projects from product development to regulatory filing (bio batch testing, support to bio equivalency studies, and ANDA filling). Developed and validated USP & in-house test methods for the analysis of finished products (i.e. generic version for Prozac and Premarine).• Successfully completed two major blockbuster products from development to bio-batch production. Performed bio equalency dissolution tests (immediate release and controlled release) on the generic and brand products• Provided analytical support (HPLC and Dissolution tests) to new product development and process validation work Antidepressant Drugs.• Actively involved in addressing the FDA comment letters on ANDA’s. Investigated out of specification results and wrote deviation reports.• Calibrated HPLC, GC, IR, UV/VIS spectrophotometers, dissolution apparatus.

• About 5 years worked on method development and validation of test methods for injectable products under consent decree.• Worked on about 40 products (solids, Injectables) under consent decree project, Global QA analytical Development. Successfully developed and validated analytical test methods and resolved regulatory and compliance issue related to test methods.• Developed and validated USP & in-house test methods for the analysis of bulk drugs and parenteral products (ESI Lederle Products) associated with consent decree project.• Identified related compounds, degradation products and impurities observed in the finished and bulk materials using LCMS.• Developed a new HPLC method for the analysis of for anesthetic and adrenergic compounds.• Actively involved in the stability testing program. Identified impurities and degradation products observed in drug substances and drug products following ICH guidelines.

• Worked for privately held 201-500 employees Generic pharmaceutical company • Coordinated work with QC/QA, R&D formulation, raw material, finished products, and stability departments• Provided analytical testing support for ANDA filings.• Responsible for GMP training to analysts and managing analytical laboratory interfacing with 6 supervisors and 80 analysts.• Analyzed drug products (tablets, capsules, liquids and ointments), raw materials as per USP, BP, and in-house specifications, which include potency, dissolution, impurities and wet chemistry.

• Developed HPLC assays for the analysis of excipients in protein formulations.• Validated HPLC assays for the analysis of amino acids and sucrose.

• About 5 years worked for public company 10001-+ employees Pharmaceutical industry• Conducted research on the application of HPLC/UV/PDA, LCMS and GCMS techniques for screening bioactive natural products. Research work has been published in international journals. • Applied spectroscopic techniques (IR, UV, MS & NMR) for the characterization of bioactive natural products and degradation products. Identified new bioactive compounds.• Introduced the combined use of HPLC/UV/MS technique for the detection, and identification of antibiotics, and cardio-protectants.• Developed GC/FID and GC/MS based methods for the analysis of optical isomers, D, L-aminoacids, DAP isomers, sugars and fatty acids, and successfully applied for the chemotaxonomic studies on Actinomyceties.

• About two years worked as a research associate and successfully applied spectroscopic GC, GCMS, and FAB MS technique for the analysis of anti-cancer drugs.• Separated and identified isomeric Deaza-adenosine compounds using TMS derivatives and GC/MS techniques.• Investigated the use of deuterium labeled m-Nitrobenzylalcohol as a matrix for the FAB-MS analysis of antitumor agents.