Mahendra Pallapothu Email & Phone Number

Montreal, Qc, Ca

Successfully designed a novel single use fermenter for a Norwegian client and reduced cost foot print by 80%. Proposed a novel fermentation strategy to maximize the utility of the SUF system and reduce the variable costs.Supporting a client in animal therapeutics segment in the expression of various antibodies in Pichia host, DSP and final formulation.Designed a novel SUF and RUF systems independent of agitation system, which will be of high value in animal health industry due to its attractive cost.

Successfully managed validation of process equipment for vector vaccine production (IQ/OQ/PQ) such as P&ID, electrical, CIP, sterility hold, broth simulation studies, etc. Modified the aeration system to meet the cell culture process. Authored SOPs & validation reports.Reduced costs by 76% by redesigning the virus production process & reducing concentration of one of the key medium components while increasing a log titre.Designed & optimized an in vitro relative potency assay using DoE & created detailed protocol for validation that is compliant to ICH Q2(R1) & VSM 800.112.Mapped the value stream for ONRAB vector vaccine (start-to-finish) & increased production efficiency by 20% by eliminating muda (waste).Introduced staggered shifts & delivered 2.8M doses of ONRAB to US Wildlife Services, USDA, within three months.Successfully reduced the documentation burden by 70% in production & supply-chain processes & received accolades from production team & customers.Successfully rolled out Continuous Improvement initiative by training nine staff members on Kaizen process & contributed to production efficiencies.Managed the supply chain of vaccine products to various Ministries/Departments in Canada and USA.Managed internal R&D and external research at various partner locations.

Offering Management Research services to a Canadian academic institution.Developed a business plan for Anquagen LLC, an innovative biotech company in the USA focusing on creating rational science based solutions for animal health industry.Completed strategic aquaculture market analysis for entry into fish vaccines business in India

• Directly supervised 6 scientists, managed budgets & company's product portfolio from R&D to manufacturing.• Ensured R&D projects are delivered as per project plan in time & budget through SMART goals. Created project plans, defined KPIs, & efficiently executed from project charter. Deployed risk mitigation strategies & realigned the project teams to bring projects back on track. Communicated lessons learned to the teams & senior management.• Secured IRAP (Small & Medium Size Project), IRAP-YES, & SWODF funds thus reduced R&D operational costs by ~80%.• Obtained BL-2/PPC-1 facility licenses from PHAC-HC & OBCS-CFIA, respectively. Designed, established & successfully commissioned experimental green house for testing inoculants in vivo.• Established & led quality program, & documented various manuals, quality documents & policies.• Efficiently managed the Company’s investments & reduced costs by 68% through innovative ideas, creativity & sourcing equipment from secondary markets.• Successfully selected three efficient Rhizobial strains using in vivo testing. Optimized seed, batch & HCDC fed-batch media using DoE & successfully confirmed the robustness of the media with other strains (9 & 12 logs of viable cells in batch & fed-batch, respectively). Designed facilities, equipment & processes for commercialization of inoculants. • Created an evidence-based business plan worth $17.2M for biological business venture & developed $3.5M budget.

•Led the R&D function and developed the strategy to expand into international markets.•Managed R&D, operations and supply chain for Canadian aqua market and implemented our corporate strategy for vaccines business. •Contributed to strategic growth of our vaccines business by lead finding.•Coordinated several activities with contract manufacturer, Canadian Centre for Veterinary Biologics, Canadian Food Inspection Agency (CCVB-CFIA), Office of Bio-containment and Safety (OBCS), contract research laboratories and the customers. Successfully launched first autogenous vaccine for Canada and delivered product to the customers.•Liaised with CFIA and obtained autogenous product license for farmed fish.•Conceptualized product portfolio for Norwegian market.

•Developed vaccines portfolio and managed R&D activities for Americas, EU and Asia-Pacific markets.•Designed and successfully developed a first-of-its-kind vaccine with prophylactic formulation for single injection to target species.•Designed a novel vaccine for fast and slow release of interfering antigens from the same formulation.

Basel, Baselstadt, Ch

Managed vaccine development function, technical teams and led global project teams for various new vaccine entity/life cycle management portfolio of projects. Acted as principal liaison for Portfolio Management Committee & global tech-transfer teams.Co-authored various scientific investigations and abstracts. Presented papers in international conferences.

Conceptualized & developed new vaccine products and optimized the licensed products (LCM) for vaccines. Coordinated the in vivo testing and in vitro analysis for new vaccine products.Generated data and authored regulatory submission packages (Dossier, Outlines of Production [FFM & FEO], Special outlines, SOPs) and obtained PMA/MA in differenct countries.Lead multimillion dollar global and domestic vaccine projects for USA, Norway, Chile, Faroes and Canada.

Conceptualized & developed new vaccine products and optimized the licensed products (LCM) for vaccines. Coordinated in vivo testing and in vitro analysis for new vaccine products.Generated data and authored regulatory submission packages (Dossier, Outlines of Production [FFM & FEO], Special outlines, SOPs) and obtained PMA/MA in differenct countries.Lead multimillion dollar global and domestic vaccine projects for USA, Norway, Faroes and Canada.

Paris, France, Fr

Managed technical project team and ideation to optimize the processes for microbial fermentations and mammalian cell culture / virus production. Invented and optimized novel defined and semi-defined medium for Diphtheria toxin production for which Sanofi filed a patent (PCT/CA2004/002024). Rederived the working cell bank for C.diphtheriae in animal-component free medium and invented an optimal lyophilization buffer and freeze-drying process. The medium and process were patented by Sanofi. (PCT/CA2004/002025) Lead a validation team for a cancer project.Authored the techtransfer documents to transfer the processes to pilot and production plants in Canada and France.Authored BPRs, SOPs and the media formulation records for the above processes.

Toronto, Ontario, Ca

Involved in the characterization of the Pgp and MRP in the MLS-9, RBE-4 and DI-TNC cell lines using sp. substrates and inhibitors. Optimized the culture and experimental protocol in 96 and 48 well formats for primary cells.Co-authored abstracts on drug transport mechanisms by Pgp, MRP in MLS-9, RBE-4 and DI-TNC cell lines.

Hyderabad, Ts, In

Developed upstream processes for Lovastatin,Cyclosoprin-A, HBsAg, rhG-CSF, rh-GM-CSF, rhIFN-a2b using fungal, yeast and bacterial systems respectively.Developed upstream process for the expression of Erythropoietin in CHO cell line.Developed various cytokine bioassays to measure the specific activities of recombinant therapeutic molecules.Developed microbial effluent treatment processes to reduce the BOD and COD of Rifampicin effluents.Designed an inexpensive diffuser for activated sludge treatment process and successfully increased the OTR and stabilized the organic compounds in the effluent.

Mba, Biotechnology Mgmt, Innovative Mgmt & Entrepreneurship

M.Sc., Industrial Microbiology

Certificate, Frontline Managers Training

B.Sc., Microbiology, Zoology, & Chemistry

Critical Chain Project Management & Theory Of Constraints

Certificate, Project Management

Diploma/Ceritificate, Molecular Biology

Post Graduate Diploma, Environmental Education & Management