Download 1174CV Dr Satyen Torne US 2016

Satyen Torne
104, Fallsgrove Blvd. #3302 Rockville, MD 20850
Phone No.: +1 267-776-0973, +32 473-330-141
E-mail: [email protected]
EXPERIENCE
15 years of working experience in pharmaceutical research and development at various levels, Expertise in
drug delivery for solids, liquid and parenteral dosage forms, vaccines and lyophilized parenterals. Hands on
experience in formulation development of small and large molecules, formulation of high potency
compounds lyophilization cycle development and nanosuspensions.
Education : Ph D (pharmaceutics)
I have a valid long term visa (L2) and valid employment authorization (EAD) to work in USA for any company
without any sponsorship.
PROFESSIONAL EXPERI ENCE
March 2016- till date: Principal Scientist: Janssen Research & Development (J&J) Belgium
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Leading formulation development and tech transfer projects for liquid and parenteral products.
Senior scientist with solid knowledge and experience in diverse areas of formulation & process
development and scale up.
Proven skills in formulation & process development for complex products for small and large
molecules, Vaccines, peptides, neucleotides, proteins and polysaccharides.
Formulation development of poorly soluble drugs; oral controlled release multiparticulate
formulations, nanosuspensions.
Hands on experience with clinical manufacturing and scale up of parenteral formulations.
Oct 2013 – March 2016: ‘Formulation expert’ at Novartis Vaccines Italy
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Lead MS&T secondary process sciences group that is responsible for development of new and
improvement of current formulations and processes for mono and multivalent vaccines.
Contributed to CMC development strategy for products in development and technology transfer.
Worked in a highly matrix structure of individual contributors as well as department heads.
Provided scientific and statistical knowledge to analyze data to process understanding, and to
identify root causes of product and process failures.
Active participation in ensuring the robustness and capability of manufacturing and packaging
processes by monitoring of each products Critical Process Parameters (CPP) and Critical Quality
Attributes (CQAs) thru a continued process verification program and review of Annual Product
Reviews (APRs)/Product Quality Reviews (PQRs)
Active role in process improvement by implementation of QbD and PAT in production environment.
Successfully implemented new initiatives and processes leading to substantial cost saving and
increased productivity.
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Lead technical transfer activities into the site by working across units and functions within the Site
and in close collaboration with MS&T global team to resolve issues and to ensure process
capability.
Acted as a subject matter expert for other departments regarding particulate matter identification
and analysis in finished product.
Feb-11 – Oct-13: ‘Associate Director-Formulations’, Kemwell Biopharma Bangalore.
 Lead the CMC Team for developing and implementing the technical and development strategy for
products in development for solid as well as parenteral dosage forms.
 Served as a primary scientific and technical advisor in formulation development area. Responsible
for enhancement of the company’s capability in formulation development and training others. The
role included bringing in new concepts of formulation development and provide creative scientific
basis in formulation design. Preparing proposals, budgets and timelines, monitoring the technical
and financial progress of assigned projects. Preparing protocols and technical reports. Ensuring that
formulation work in the laboratory is scientifically sound and meets the objectives of the sponsor.
 Department head for formulations development department, a team of 22 scientists - Phase I, II
and late phase development, NCE formulations development, ANDA and formulation development
for other regulated markets like Europe.
 Delivered several projects involving QbD. Hands on experience on software like Minitab, Design
expert, Statistica, Gastro plus and DDD plus.
 Expertise in CMC compilation and responding to queries regarding formulation development, scale
up and validation batches.
 Dosage forms: Solid orals: tablets, capsules and pellets, liquid orals, Semisolids: Gels, creams and
ointments and parenterals.
Jan 2009 – Feb 2011: ‘Group Leader’ at Piramal Healthcare, Ahmedabad
 Responsible as a group leader formulation development for NCE’s early as well as late phase
development including 505(b) (2) applications projects for US and UK clients. Responsible for
developing a CMC strategy and execution of project including development, technology transfer
for low soluble API and solubility enhancement of small molecules using various platform
technologies.
 Hands on experience in formulation development of high potent compounds, facility design for
handling of category 4 molecules, OEL studies and qualifying the facility for handling highly potent
molecules.
 Successful delivery of development project involving design of experiments DoE, familiar with
Quality based design. Dosage forms: solids orals: tablets capsules.
 Hands on experience in executing early phase development projects, pre-formulation studies,
parenteral suspension of proteins as well as novel drug delivery projects and late phase projects
including ANDA.
 Responsible as a core team member for development and implementation of Laboratory
information management system (LIMS) in site.
March 2008 – Jan 2009: ‘Head R&D’ at Kusum Healthcare, Delhi.
 Joined as Head of Research and development to Kusum healthcare Delhi, an export oriented
Pharma Company with strong presence in Ukraine and eastern European countries.
 Responsible for setting up R&D from scratch, equipment selection and team development.
Successfully developed and launched several immediate and controlled release formulations.
 Responsible as a head of R&D team for Formulation development for European countries,
Analytical method development, scale up and technology transfer, Regulatory Affaires- Dossier
compilation as per CTD format, vendor development for API and new source evaluation for existing
products.
October 2004 – March 2008: ‘Senior research fellow’ at Institute of Chemical Technology, Mumbai
 Pursued Ph.D. in Pharmaceutics under the guidance of Prof. P.R.Vavia.
 One year in University of Torino, Italy on collaborative research work.
 Filed three patents.
 Developed parenteral suspension for peptide molecule for an overseas company. Hands on
experience on lyophilization.
2003 –2004: ‘Senior R & D Officer’ at FDC Ltd., Mumbai
 Experienced in Scale up, validation, technology transfer for solid, semisolid and liquid dosage forms
and technology transfer for the regulated market.
 Developed and launched 6 products for domestic market and one for UKMCA.
1999 – 2003 ‘R&D officer’ at Blue Cross Laboratories Pvt. Ltd. Nashik)
 Product development including formulation and developing analytical methods for drug
formulations, stability study and method validation.
 Worked on sustained release dosage forms using solid drug layering technique.
 Technology transfer for solid and liquid and semisolid dosage forms.
 Worked on projects involving Fluidized bed coating and fluidized bed coater granulator.
REFERENCES
Prof. P.R.Vavia
Dean academics and Professor of Pharmaceutics, Institute of Chemical Technology
Email: [email protected]
Cell no: +91-9867841777
Dr. Ninad Deshpande
President, Research and Development, Aurobindo Pharma USA
+1-919-630-7176
Dr. Rene Holm
Head & Scientific Director Research & Development-– Parenterals & Liquids
Janssen Pharmaceutica NV Belgium
Email: [email protected]
+32 0473 798456
Personal profile
nd
Date of Birth - 2 July 1975
Marital Status - Married
Language Known - English, Marathi, Hindi, Italian
PATENTS AND PUBLICATIONS
Patents:
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International patent on novel formulation of cyclosporine. Title: “Oral
Pharmaceutical Composition” Publication number: WO2006123354. Publication date: 2006-11-23.
http://patentscope.wipo.int/search/en/WO2006123354
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International patent on novel nanosponge based formulation for Paclitaxel delivery.
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Title: “NANOSPUGNE A BASE DI CICLODESTRINE COME VEICOLO PER
FARMACI
ANTITUMORALI”. MI 2007 A 1321. DT: 04/07/2007. Applied at Italian patent office.
Publications & Presentations:
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Cyclodextrin-based nanosponges: effective nanocarrier for Tamoxifen delivery. Satyen
Torne, Sharad Darandale, Pradeep Vavia, Francesco Trotta, and Roberta Cavalli,
Pharmaceutical Development and Technology, 2012, 1–7
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Paclitaxel Loaded Nanosponges: In-vitro Characterization and Cytotoxicity study on MCF7 cell line culture. Current Drug Delivery (2011) Volume: 8, Issue: 2, Pages: 194-202
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Novel Cremophor free formulation of Paclitaxel for IV administration: Safety, Stability
andPharmacokinetic profile.- under publication
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Enhanced
Oral Paclitaxel
Bioavailability after administration of PaclitaxelLoaded Nanosponges.- Drug Delivery, Volume 17, Number 6, August 2010 , pp. 419425(7)
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Formulation of β-cyclodextrin based nanosponges of Itraconazole. Vavia PR, Swaminathan
S, Trotta F and Torne SJ. 2007. Journal of Inclusion Phenomena and Macrocyclic
Chemistry 57(1-4): 89-94
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Cyclodextrin based drug delivery system of protease inhibitor—Nelfinavir mesylate S.
J. Torne , J. S. Torne , P. R. Vavia , S. K. Singh and N. Kishore . 2007 Journal of
Inclusion Phenomena and Macrocyclic Chemistry 57(1-4): 689-697
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Cyclodextrin based Nanosponges as delivery systems for active molecules.
PosterPresented at Italian cyclodextrin symposium 2007
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Presentation at 50th Indian Pharmaceutical Congress. Jan 1999 Title: "Synthesis and
QSAR of Dibenzoxazepine antidepressant analogs."