Jordi Bacardit

EDUCATION

1989-1993
Faculty of Chemistry (University of Barcelona)
Barcelona (Spain)

Degree in organic chemistry.

1993-1994
Peptide Research Group at the Faculty of Chemistry
(University of Barcelona)
Barcelona (Spain)

Master in organic chemistry.

Defended on 07/20/1994 about synthesis and structural studies of fragments of Uteroglobin, under the supervision of Prof. Ernest Giralt and Dr. Ernesto Nicolás.

1994- 1998
Peptide Research Group at the Faculty of Chemistry
(University of Barcelona)
Barcelona (Spain)

Ph.D. obtained on May 14th 1999.

The subject of the research project conducted was the synthesis and study by 2D NMR of certain peptide-leucotriene antagonists and certain peptides, fragments of Uteroglobin, which act as Phospholipase A2 inhibitors. This project, was funded through a co-operation agreement between the research group and Laboratorios Menarini. The experimental part of this research project finished on June 1998 date at which I joined Lipotec.

1996- 1997
Forschungsinstitut für Molekuläre Pharmakologie
Berlin (Germany)

Four months stage (October 1996-March 1997) at Dr. Beyermann´s laboratory with the aim of studying difficult couplings both in solution and solid phase of alkyl N-substituted amino acid derivatives. The synthesis of multigram amounts of some Fmoc-Amino acid fluorides was required.

ADDITIONAL TRAINING
LANGUAGES :- CATALAN AND SPANISH (mother tongue), ENGLISH, FRENCH, ITALIAN, GERMAN, ITALIAN AND PORTUGUESE
OTHER:-
Computer Knowledge
User of applications for both Macintosh and PC environments. Wide experience with the Microsoft Office package for the writing of DMFs (Datasheet, Word Processor and Access Data Base). Also good skills in preparing presentations using Power Point.
Implementation of ERP from a user point of view. Lead the implementation of Ekon (By CCS) during the time at LIPOTEC.
Autocad operator Knowledge of particular use for conceptual design of facilities and for reviewing and approving the conceptual design.
Experience with Analytical techniques
Experience in the following techniques: 1D and 2D NMR (user of a 300 MHz VARIAN Unity plus, a Varian VXR-500 MHz and a Bruker AMX-500 MHz, FT-IR Nicolet Plus, UV Perkin Elmer and Varian Cary, HPLC reversed phase (development, implementation and validation of analytical methods), GC-Hewlett Packard, LC-MS Fisons VG-4, Polarimeter Perkin-Elmer, MALDI-TOF Bruker-Biflex, Circular Dichroism Jasco-720, HPCE with Waters and Applied Biosystems equipments, Micro-Karl Fischer Mettler-Toledo. Wide experience in applying the analytical methods described in the monographs to the laboratory.
At Docuchem, worked on analytical R&D for formulations on behalf of third parties, mostly injectables, ophtalmic solutions and ointments. Difficult challenges faced succesfully for related substances of molecules such as gatifloxacin, alpha/tocopherol.
Quality assurance and GMP implementation
Experience in the implementation of quality systems is available from time at Lipotec where I contributed to a successful FDA approval of the facility and from Docuchem time giving consultancy to Indian companies for facility and Quality system upgrade. One of the companies is already European and USFDA approved.
Regulatory affairs
Experience with DMFs for API in CTD format comes from the initial tasks at Lipotec where we successfully filed (and obtained) four Certificates of Suitability for peptides. During Docuchem time I have given consultancy on DMF writing and on planning of the different experiments to be conducted specially on the characterisation and impurity profile sides for peptides and other molecules. Filling of CoS for six peptide molecules by Indian company.
Qualification and validation
Equipment qualification was learnt also during the build up and start up of the Gavà facility for the manufacturing of Peptides at Lipotec time. During consultancy the different projects undertaken and the experience and learning acquired have consolidated the initial knowledge to levels of Facility Manager.
GMP audit
Conducted 98 audits to a pool of manufacturers of API, finished dosage forms and packaging material on behalf of third parties in India, China, Europe and Australia.
Design and engineering.
Participated in the design of a facility for the manufacturing of peptides as raw materials at the time in Lipotec (a new unit at Gavà) and in the design of a injectable hormone finished dosage form facility and an injectable cytotoxic drug unit while at GP Pharm
Project leader of design of a manufacturing facility for peptides in India including the handling and finished steps of the manufacture of the same. Designed a facility for pelletisation and drug coating in Hyderabad. Made designs for projects for cephalosphorins both in injectable and oral grades as well as a purification plant of Eritropoyetin in Pakistan.
Pharmaceutical Development
Developed formulations for injectables of peptides and combination of peptides with excipients to delay its release.
Developed formulations for ointments and ophtalmic solutions
Developed formulations for Sterile wipes for treatment of blepharitis.
Developed formulations for topical delivery of peptides to treat Vitiligo.
Developed numerous analytical methods by HPLC and LCMS for different projects from companies around the globe.

WORKING EXPERIENCE

23 Years of work experience with Active Ingredient, Pharmaceutical and Biopharmaceutical manufacturers. Last fourteen as a consultant on own company (Docuchem) that was then taken over by SVS in Feb. 2008 and that I bought back from SVS on March 2010.
Work experience

1996-1998
University of Barcelona
Barcelona

In charge of a MALDI-TOF MS facility at the department of Organic Chemistry analysing samples both coming from the faculty or private companies. Maintenance of the equipment and training of the self-users were two of the responsibilities of the job.

1998-2006
Lipotec S.A.
Barcelona

Since July 1998, as the Officer for Regulatory Affairs, I had the responsibility to co-ordinate and supervise the work done in the analysis department for the implementation and validation of new analytical methods to characterise the active ingredients. In this years of work I have been in charge of the communications with the European Department for the Quality of Medicines, assisting to meetings of the expert group number 6 to discuss which analytical method should be applied for the characterisation of several peptides. During that time, seven DMFs have been written, and four of them (Somatostatin, Leuprolide, Salmon Calcitonin and Desmopressin) were submitted to the EDQM and succesfully got the Certificate of Suitability (CoS) of the European Pharmacopoeia.
During the spring 1999 I closely collaborated with the Quality Assurance Unit in the writing of SOPs and in the update of the quality system in order to comply with ISO9001 regulations. A certificate of compliance was awarded to Lipotec in July 1999.
As the Director for Regulatory Affairs it has also been my responsibility to prepare and supervise the application of ICH compliant stability plans which are applied using validated analysis methods. The regulatory affairs department actually employed three people that were directly supervised by myself.
For the opening of European and US markets, Lipotec adapted the production site in order to comply with GMP regulations for the production of peptides. My collaboration in that matter has been to search for the correct regulations and to make necessary recommendations to the quality assurance unit and to the management in order to apply necessary structural changes. Lipotec became FDA approved for Tetracosactide during 2006.
I worked closely with the Quality Assurance unit auditing suppliers and actively participating in the audits that the factory went through.
Since May 2005, I was been appointed Manager of the International Division of GP Pharm SA, a Pharmaceutical Company within the Lipotec group manufacturing finished dosage forms of peptides and cytotoxic compounds, whose in and out-licenses promotion were my main responsibility. I acted as member in the board of directors of the company.

DOCUCHEM SLU/HEMMO PHARMACEUTICALS

2006 – on going
Since February 2006, I incorporated my own company that acts as a consulting company for building up GMP environments and help in the creation of GMP related documentation including CTD files. Numerous third party quality inspections were executed during that time on behalf of pharmaceutical companies.
Docuchem was involved in several contracts, one in India and a second one in Brazil for the build up and GMP upgrade of a facility for the manufacture of sterile API and for a pharmaceutical facility for injectable hormones respectively.
Consultancy on Regulatory affairs, facility design, Quality System setting and also external management was given to several companies in India and abroad.
In docuchem managed several pharmaceutical developments for injectables, ointments, ophthalmic solutions and topical products.
Incorporated SVS Life Science Private Ltd. in India in co/ownership with SVS. Sold the shares of that company to SVS group in March 2010 when I bought back full control of Docuchem. The indian company had six employees and was profitable since the first year working on consultancy for the pharma companies.
In partnership with Hemmo Pharmaceuticals have established a Public Testing Laboratory in Navi Mumbai (India) with 8 employees and have and R&D team for formulations of 12 people in the Thane district of Mumbai. The PTL lab was closed in 2017 and the testing activities were concentrated only on the Spanish site.
Acting as a consultant to Hemmo Pharmaceuticals I do have the role of COO of the peptide manufacturing facility of Navi Mumbai where I have introduced technology and processes for the manufacture of 23 peptide API’s by solid phase and combinations of solution phase chemistry in some of the cases.
Lead an R&D centre at the Science park in Girona with 2 pharmacists and fourteen chemist working on conceptual development of peptide processes and formulations for peptides as well as non peptide based products and development of analytical methods for Drug Substances, Drug products and medical devices.
Lead to Docuchem to obtain EUGMP approval in 2017 after inspection of the Spanish Drug Agency (Agemed) for the physico-chemical control of drug substances, drug products and investigational drugs for the laboratory located at the science park in Girona that currently employs 25 people.