Luis Maranga, Phd Email & Phone Number

Boston, Ma, Us

Leading a team > 650 people, responsible for all cell and genetic therapies CMC functions, from post Discovery to Commercialization, including 2nd generation development. Activities include DS and DP Process Development, Analytical Development, Device Development & Engineering, CMC Program Leadership and CMC Project Management, and internal GMP Clinical and Launch/Commercial Manufacturing for Cell and Genetic Therapies, Devices, and Combo products. Team located across sites in Boston, Cambridge, Providence and San Diego.

Cambridge, Ma, Us

Represented the Sanofi at MIT LGO Governing Board for the Dual Degree MS Engineering (School of Engineering) and MBA (Sloan School of Business) program.https://lgo.mit.edu/

Princeton , Nj, Us

Caravan Biologix is developing allogeneic cancer cell therapies.

Paris, France, Fr

Led a 400+ person global MSAT team, in Manufacturing & Supply Specialty Care, responsible for biologics commercial manufacturing support, next generation CMC development, tech transfer, validation, and LCM across 10 internal Sanofi DS and DP sites (US and EU) and two dozen external CMOs.Provided technical support to €15 billion Specialty Care biologics portfolio, projected to double in 5 years. Successful executed ~ 50 DS & DP tech transfers.Implemented 2nd gen processes for six different biologics, contributing to >$500 million annual COGS savings. Additional 2nd gen processes in development or implementation stage for other six biologics.

Waukesha, Wi, Us

The Bio-Industry Committee is responsible for providing input on biotechnology industry trends affecting the gene therapy sector, such as manufacturing, investment, and market trends. The duties of the committee include recommending sessions relevant to the industry and the Society for the Annual Meeting, and serving as a networking resource to Society members from industry.

Cambridge, Massachusetts, Us

- C-level member of the Voyager's Executive Management team, reporting directly to the CEO.- Responsible for all Technical Operations functions (Portfolio Strategy, Technical Development, Manufacturing, Supply Chain, and Quality).Key accomplishments:- Established a high performance TechOps organization, growing from 8 to 50+ FTEs in less than 18 months.- Set-up state of the art AAV gene therapy technical development laboratories enabling process, formulation, and analytical development for multiple product candidates. - Established 250-L Pilot capabilities to enable material production for GLP toxicology studies.- Led the successful development of processes and analytical methods for 3 gene therapy clinical candidates. - Led S&E to establish partnerships with clinical and commercial ready network of CMO/CROs. Successfully transferred manufacturing processes and analytical methods for 3 different clinical candidates.- Led successful IND filing and clearance for clinical candidates.- Led new IP strategy and filed over 20+ novel applications covering novel technology for AAV manufacturing- Led the design of a $100MM manufacturing facility to enable both clinical and commercial gene therapy product manufacturing.

Lawrence Township, Nj, Us

- Head, Biologics Development, overseeing all activities from post-Discovery to Commercial launch in regards to: cell line, process and analytical development, and clinical manufacturing to support BMS pipeline. - Responsible for a team of 500+ in facilities across Devens, MA; Hopewell/New Brunswick, NJ; and Seattle/Bothell, WA.

Lawrence Township, Nj, Us

- Plant Manager in charge of commercial bulk drug substance manufacturing at Devens Large Scale Cell Culture (LSCC) and overall Administrative Site Lead- Responsible for site P&L and leading the following functions: Manufacturing, Quality, Tech Services, Supply Chain, HR, Finance, EHS, IT, PMO, MS&T, OPEX- Devens Large Scale Cell Culture (LSCC) facility has 6 x 25,000 L production scale bioreactors- Site has also state-of-the-art biologics development and clinical manufacturing facilities- Annual Budget (OPEX+CAPEX):~ $200MM- Site population: ~ 750 people; 400+ direct FTEs

Lawrence Township, Nj, Us

Site Head for Hopkinton Biologics Development & Operations site.- Led the construction, staffing, and start-up of a new BMS Biologics site in Hopkinton, MA.- Hopkinton site grew to >100 FTEs in MS&T, Process Development, and Analytical Development, working on late stage-development and commercial manufacturing support.- Role was concurrent with the global leadership of BMS' Biologics Drug Substance Manufacturing Sciences & Technology organization

Lawrence Township, Nj, Us

Global Leader for BMS' Biologics Drug Substance Manufacturing Sciences & Technology organization.- Responsible for all technical functions (~150 FTEs) providing direct plant and/or laboratory support to 3 internal drug substance manufacturing sites (Devens, MA, Syracuse, NY, and Cruiserath, Ireland [design/construction phase]) and 2 external manufacturing sites (Lonza, NH, and Samsung, Korea). - A total of 12 late-stage or licensed commercial biologics manufacturing processes from 5,000 to 25,000 L bioreactor manufacturing scale- Grew global MS&T organization from ~45 direct employees to 100+ direct and 50+ indirect (dotted-line) employees in a 18 month period (~ 40% Ph.D.)- Led 5 successful Tech Transfers to large scale manufacturing facilities, started 2 additional ones- Led 5 successful PPQ (Process Validation) campaigns- Led the authorship of the DS sections for 2 BLA, 3 MAA, 2 PAS (new sites), and multiple ROW regulatory filings- Led successful PAI and GMP inspections by multiple regulatory agencies- Presented to FDA multiple times, including face-to-face meetings at district and center offices

Basel, Baselstadt, Ch

Vaccine Division (now GSK and/or CSL)- Managed Director and Associate Director level reports, and a 50+ team of Ph.D. scientists & engineers working on novel vaccines for viral diseases.- Led four Technical Development functions:a) Early Technical Development (Cambridge); Cell Line Devel., Upstream, Downstream, Analyticalb) Drug Substance Development (Holly Springs); Virology, Upstream, Downstream, Analyticalc) GMP Pilot Plant Operations (Holly Springs); GMP Clinical Supplies manufacturingd) External Technical Development- Led the design and construction of a $40MM GMP Pilot Plant & Process Development facility in Holly Springs, NC. GMP Pilot Plant used mostly disposable and single use upstream and downstream technologies.

Basel, Baselstadt, Ch

Vaccine Division (now GSK and/or CSL)- Accumulated the role of Head of MS&T (ad interim) in Marburg, Germany, responsible for 40+ FTEs, concurrent with remaining US responsibilities- Led Optaflu/FluCellVax PPQ and successful BLA submission and approval with FDA- Lead technical presenter to Health & Human Services (US Government) on Optaflu/FluCellVax project

Basel, Baselstadt, Ch

Vaccine Division (now GSK and/or CSL)- Established all Early Technical Development functions (Cell Line Devel./Virology, Upstream, Downstream, Analytical, Formulation) to support all new viral vaccine projects in NV&D. New organization was co-located with Research to accelerate project transition into clinical development phase.- Recruited entire TD Cambridge personnel, and established laboratory capabilities to support the mission. Grew organization from scratch to 20+ FTEs.- Set-up and coordinated NV&D's Technical Review Board. Global TechOps/Quality/Regulatory CMC/Validation main decision body for high level technical project review.Optaflu/FluCellVax Next Generation - Global team leader of the successful development, transfer, and implementation of novel process in the commercial manufacturing facility in Marburg (Germany).

Gaithersburg, Maryland, Us

Cell Culture Development, Vaccine Development- Resposible for cell culture development team of 10+ FTEs- Member of the cross-departmental team responsible to develop and implement new Project Planning Model. - Member of the New Vaccine & Biologics Products Senior Review Team. MDCK Cell Culture derived FluMist® (Influenza Virus Vaccine Live, Intranasal)- Led the implementation of a new disposable Hyclone Single Use Bioreactor (SUB) technology in development and GMP Pilot Plant, from concept to GMP implementation in ~ 5 months. - Upstream representative in CMC cross-functional team. Upstream Tech Transfer leader to GMP Clinical Manufacturing facilities for Phase I/II/III Clinical Trial Material production for seasonal TVCC (Trivalent Cell Culture) and PPCC (Pandemic Prototype Cell Culture) Influenza Vaccine candidates.- Develop and transferred TVCC Phase I process to internal (CA) GMP Clinical Manufacturing facility, and supported fully successful Clinical Supplies production. Authored CMC for IND submission.- Develop and transferred PPCC Phase I/II process to external GMP Clinical Manufacturing facility (MD), and supported fully successful Clinical Supplies production. Authored CMC for IND submission.- Optimized medium, feed and production platform for Phase II supporting over >30 different virus strains (seasonal/pandemic) with productivity ~ 3-50-fold higher than Phase I.- Supported successful start-up and qualification of Large Scale Cell Culture (LSCC) clinical manufacturing facility - Led the transfer and implementation of seasonal TVCC Phase II process in LSCC clinical manufacturing facility.- Upstream design leader for novel Commercial Manufacturing Plant- Invented four patents on cell culture production of LAIV.

Rahway, New Jersey, Us

Fermentation and Cell Culture, Bioprocess R&D- Group leader of a cell culture team of 4-6 FTEs- Member of the cross-divisional team defining Merck’s cell culture antibody production platform (TPSSC). Monoclonal antibodies- Led the development of optimized feedings for continuous/discontinuous fed-batch production processes using recombinant CHO and NS0 cell lines, expressing monoclonal antibodies.- Led the development and scale-up of robust and highly productive fed-batch production process for a monoclonal antibody with CHO cells, at 2,000 L scale, to supply Phase II clinical grade bulk drug material. First time a CHO based process was developed and implemented at Merck under GMP.- Transferred Phase II process to GMP Clinical Manufacturing facility, and supported fully successful Clinical Supplies production at 2,000L scale. Authored CMC for IND submission.- Upstream bulk process representative to the CMC team. Tech Transfer leader to the Bulk production facility. Represented CMC team and make presentations at PDT meetings.Varicella/PHN Vaccine (Varivax® and Zostavax®)- Led the development of scale-down laboratory and pilot systems for downstream processing of bulk materials containing live viral vaccines. - Led downstream processing studies to support the start-up of a new Commercial Manufacturing facility.- Conducted engineering runs for lower BSA process in collaboration with Viral VTE (MMD).- Member of the TT team. Presenter to BPCC.

Rahway, New Jersey, Us

Fermentation and Cell Culture, Bioprocess R&DAdenovirus vectors- HIV candidate vaccine - Led the development of optimized and more robust continuous feeding fed-batch production processes for replication deficient adenovirus vectors that yielded improved titers and wider infection cell density windows. - Co-developed the new generation of in-house serum-free medium for adenovirus production. - Developed novel and improved perfusion processes for enhancement of PER.C6® cell concentration for adenovirus production in bioreactors.

Oeiras, Pt

Animal Cell Culture Technology Lab and Pilot Plant UnitProjects developed:- Porcine parvovirus VLP baculo derived vaccine - E-nose technology application in animal cell cultures- Human FuctIII recombinant production with baculovirus infected insect cells- Rotavirus VLP baculovirus-derived vaccines-Represented IBET and made presentations at external European Project Coordination Meetings (Project partners from Austria, Germany, Spain, France, The Netherlands, UK, and Sweden)

Lisboa, Lisboa, Pt

Chemical and Environmental Sciences Undergraduate Program (Biotechnology branch)- Responsible for the 3rd year courses of Industrial and Biochemical Project Design I and II. Modules Lectured: Market analysis for the biochemical industry, sources of data, tools and estimators; Industrial project design concepts; Mass and energy balances in steady and un-steady state for bio/chemical systems; Unit operations used in the bio/chemical industry; Process equipment design; Industrial diagrams; Utilities and industrial services; Process economics.

Amadora, Pt

Analytical Sciences, Quality Control Department- Performed stability studies and developed mathematical models for active ingredient degradation kinetics in high temperature controlled studies. - Developed and validated a HPLC method for analysis of the active ingredient and all four excipients in the Magnesona© product (1st product of the company in annual sales). - Developed and validated a colorimetric method for the titration of magnesium in raw materials using an automatic titration system with a photoprobe.- Develop FTIR based methods, databases, and software algorithms for incoming API and excipient raw material identification and implemented procedure for individual container testing in the manufacturing plant

Lisboa, Lisboa, Pt

Biological Sciences Research Center - Department of Chemical Engineering. Supervisors: Isabel Sá-Correia and Jorge Leitão- Characterized and performed molecular typing of Burkholderia cepacia isolates from a Cystic Fibrosis Center by Pulsed-Field Gel Electrophoresis (PFGE). DNA fingerprintings of several clinical Burkholderia cepacia isolates were analyzed to assess the occurrence of nosocomial infections and improve operational procedures at the Cystic Fibrosis Center to reduce the risk of nosocomial acquisition of the fatal pathogen.

Ph.D., Chemical Engineering

5-Years Honors Degree (Bs+Ms), Chemical Engineering/Biotechnology Branch