Júlia C. Oliveira, MSc

Rua Álvaro Pedro Gomes, nº9-2ºD, 2685-140 Sacavém - PORTUGAL

e-mail: acdete@r.postjobfree.com Mobile: +351-**-**-**-***

PROFILE

A highly motivated and flexible person currently seeking a Management position abroad in the Quality field

(QP, QA, QP/QA, or other Management function related with Project Management, Pharmaceutical

Development or Technology Transfer), in the pharmaceutical industry, where their education, experience and

skills of +20 years in the pharma/ biopharma, sterile/ non-sterile industries will add significant value.

Innovator and results-driven inspiring leader focused on achieving exceptional results in high competitive

environments that demand continuous improvement. Strong analytical, problem solving and team

management skills. Proactive and enthusiastic to team work and with proven ability to meet deadlines. With

excellent interpersonal skills and ability to develop relationships with multiple stakeholders across diverse

scientific disciplines and multicultural environments.

PERSONAL ATTRIBUTES AND SKILLS

• EU Qualified Person under directive 2001/83/EC and 2001/20/EC and for Switzerland (IMPs

and Marketed Medicinal Products) and responsible for Quality Assurance Management.

• Experienced in Pharmaceutical Development, Technology Transfer, Analysis and Manufacturing of

solid, liquid and semi-solid, injectables, sterile and non-sterile pharmaceutical dosage forms.

• Familiar with Pharmaceutical Development, Technology Transfer, Analysis and Manufacturing of Cell

and Gene Therapy products (i.e. autologous and / or allogeneic), vaccines, virus production and

testing.

• Experienced in Good Tissue Practices and in blood and stem cell banking (i.e. autologous and / or

allogeneic stem cell).

• Very strong skills in pharmaceutical development using statistical tools with proficiency (QbD and

DoE, Minitab).

• Strong skills in Validation of Analytical Methods and of Manufacturing Processes at industrial scale.

• More than 20 years of experience working with GXP standards as defined in the ICH Guidelines and

in EC Directives. PIC/S, ISO 9001:2008, with detailed knowledge and ability to Audit and evaluate

compliance.

• Experienced in negotiation of Supplier/Contract Manufacturing, Secrecy Agreements and Quality

Agreements.

• Strong Managements skills with a proactive and enthusiastic approach to team work and ability to

deal with multicultural environments. High self-motivation and flexibility with proven ability to meet

deadlines and committed to the objectives and goals of the business.

• Facilitator of communication between different Department and technical-scientific disciplines.

• Experienced in Risk Management, deviations, CAPA and Change Control Management.

• Black Belt in Lean Six Sigma with strong skills in Process Improvements.

• Strong communication skills in Portuguese (mother tongue); Fluency in English, French and Spanish

(oral and written).

• Good working knowledge of MS Office (Word, Excel, PowerPoint).

CAREER HISTORY

I am currently working for 3 companies that are all part of the same business (i.e. MEDINFAR Group).

I started working at Laboratorio Medinfar in 1993 holding several positions within R&D and Quality

Assurance. In 2010 I started working at Genibet Biopharmaceuticals where Laboratório MEDINFAR is

one of the shareholders. Here I am the QP. In 2011 started working at Cytothera also owned by

Laboratório MEDINFAR.

Cytothera (part of Laboratório Medinfar – working here, as requested, 25% of my time).

Cytothera is a blood bank which cryopreserves stem cells obtained from the umbilical cord blood and which isolates, multiplies and

cryopreserves mesenchymal stem cells from the umbilical cord tissue to be used in autologous and/or allogeneic cellular therapies.

Deputy-CEO 2011 - Present

• Responsible for planning, direction and coordinating the actions leading to the implementation of the

policies of the company as well as of the Good Tissue Practices and correspondent procedures to

obtain the respective Certifications and Authorizations to the regular activity of the blood and stem cell

banking (i.e. autologous and / or allogeneic stem cell).

• Assure proper planning of investments in infrastructure and equipment to ensure compliance with

standards and applicable laws.

• Active participation on the improvements done on procedures to eradicate microbial contamination of

the initial tissue and to the fast isolation and multiplication of the mesenchymal stem cells of umbilical

cord tissue and in the revalidation process.

• Representative of the General Manager on strategic partnerships with other companies and in the

management of R&D and Business Projects. Last December 2013, I got a deal for one million euros

for the supply of cryopreservation services to a third party.

GenIbet Biopharmaceuticals, S.A. (where Laboratório Medinfar is one of the shareholders –

working here 25% of my time).

GenIbet is a cGMP biopharmaceutical CMO (Contract Manufacturing Organization) offering highly specialized Biological Medicinal

Products (Cell Therapies with human cells - Advanced Therapy Medicinal Products (ATMP) - and Gene Therapy Products (viral,

bacterial and animal cells)) and supporting the respective process developments to supply materials for use in early stage of drug

development, pre-clinical studies and cGMP manufacturing for Phase I and II clinical trials.

Qualified Person 2010 – Present

• Responsible for review the relevant documentation associated with the manufacture and testing of

Drug Substance and Drug Product Intermediates, as well as being responsible for the QP certification

of the Biopharmaceutical IMP (Gene Therapy Products (viral, bacterial and animal cells) and ATMP

(Cell Therapies with human cells) in accordance with Annex 16 of Eudralex Vol. IV. Undertake the

duties of a Qualified Person as defined in Directives 2001/83/EC as amended and 2001/20/EC and for

recording batches released in the QP Register.

• Act as a QMS and GMP Subject Matter Expert (SME) with detailed knowledge of GMPs and an

ability to analyse and evaluate GMP and Quality compliance. Responsible to facilitate the site

compliance with the company’s Pharmaceutical Quality System (PQS) and support senior QA

leadership through the QP decision making, to drive quality investigations, review and approval of

deviations, CAPA and continuous improvements.

• Responsible for self-inspections and audits of GenIbet subcontractors for analytical services.

Responsible to track customer audits and inspections of the Health Authorities and present the

available records and reports requested and by the reply to the audit/ inspection reports.

• Responsible to get, in December 2012, the Manufacturing Authorization for viral IMPs and, in January

2014, the Manufacturing Authorization for bacterial and cell IMPs, as well as for Cellular Therapies

(ATMPs).

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Júlia C. Oliveira, MSc

Laboratório Medinfar 2006 – Present

Laboratório Medinfar is a Portuguese pharmaceutical company privately owned founded in 1970. The company manufactures and

markets prescription medicines, generics, OTC, cosmetics, food supplements, veterinary products and medical devices. Laboratório

Medinfar is a trustworthy partner with long term partnership with major global Pharma companies through licensing-in, licensing-out

and export.

Intellectual Property Manager and Pharmaceutical Expert

• Responsible for managing the Intellectual Property and for research and analysis of Patent claims

suggesting alternative processes preventing infringement, and/or determination of the date on which

the Patent or the respective Supplementary Protection Certificates (SPCs) to launch the Generic Drugs.

• Responsible for writing the patent applications complying with regulatory requirements, answering

questions from "referees" during the examination phase, and/or the opposition period, and ensuring the

maintenance of patents granted.

• Assure technical and scientific support in drafting pleadings in lawsuits related to the Medinfar

Group's intellectual property, to ensure adequate reasoning processes.

• Project Management of advanced R&D Projects. Scientific Adviser for new formulations of

solid, liquid and semi-solid dosage form, as well as on innovative skin care formulations.

• Responsible to review the Pharmaceutical Report of CTD “dossiers” as Pharmaceutical

Expert and to give GMP expertise support to the other Departments and Companies of the Group.

GenIbet Biopharmaceuticals, S.A. 2004 – 2006

Member of the Board of Directors

• Involvement as GMP expert in the design of Production Units, definition of personal and material

flows and definition of user requirement specifications to the construction of the facility.

Laboratório Medinfar 2001 – 2004

Qualified Person

• Responsible for review of relevant documentation associated with the manufacture, testing and QP

certification of Medicinal Products (solid, semi-solid and liquid dosage forms to the market) in

accordance with Annex 16 of Eudralex Vol. IV. Undertake the duties of a Qualified Person as defined

in Directives 2001/83/EC as amended and 2001/20/EC and for recording batches released in the QP

Register.

• Act as a QMS and GMP Subject Matter Expert (SME) with detailed knowledge of GMPs and an

ability to analyse and evaluate GMP and Quality compliance. Responsible to facilitate the site

compliance with the company’s Pharmaceutical Quality System (PQS) and support senior QA

leadership through the QP decision making, to drive quality investigations, review and approval of

deviations, CAPA and continuous improvements.

• Responsible for self-inspections and audits of subcontractors. Responsible to track customer audits and

inspections of the Health Authorities and present the available records and reports requested and by the

reply to the audit/ inspection reports.

Laboratório Medinfar 2000 - 2004

Head of Quality Control

• Responsible to approve specifications, sampling instructions, test methods and other Quality Control

procedures, approve or reject starting materials, packaging materials, intermediate, bulk and finished

products, and to ensure that all necessary testing is carried out and the associated records evaluated.

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Júlia C. Oliveira, MSc

• Responsible to establish, validate and implement all quality control procedures, oversee the control of

the reference and/or retention samples of materials and products when applicable, ensure the correct

labelling of containers of materials and products, ensure the monitoring of the stability of the products,

participate in the investigation of complaints related to the quality of the product.

Laboratório Medinfar 1993 - 2006

Head of R&D Department

• Leader of Pharmaceutical Technology Projects from formulation to industrial scale up, with special

relevance to modified release formulations. Three patents were granted in more than 20 European

Countries, and in the USA. More than 50 new products were developed and launch in the market.

• Responsible for management of all the activities of pharmaceutical and analytical development and

activities related to adapt the older Marketing Authorization dossiers to the technical and scientific

progress (i.e., optimization and validation of analytical methods and manufacturing processes, Stability

tests according ICH Guidelines, etc.).

• Responsible for annual plan and setting annual goals of each researcher in accordance with the overall

goals of the R&D Department.

• Responsible for defining and ensuring compliance with the indicators of the R&D Department in

accordance with the Quality Management System to continuous process improvement. The first Six

Sigma Improvement Project gave €500 000/year of savings.

• Responsible for the Technology Transfer of the analytical methods and manufacturing processes (about

100 products were transferred from the Lisbon facility to the Coimbra facility and validated their

respective manufacturing processes and analytical methods at the new site).

EDUCATION

Post-Graduation in Evidence-Based Medicine.

Faculdade de Medicina da Universidade de Lisboa – Instituto de Formação Avançada. 2008

Post-Graduation in Six Sigma Black Belt.

Escola Superior de Tecnologia e Gestão de Leiria. 2006 - 2007

Certificate of Professional Competence for Training

Instituto de Formação Profissional (Certificate nr. EDF 404973/2006) 2006

Training Course for Trainers

CECOA (Certificate nr. 9107/2005) 2005 - 2006

Title of Specialist in Pharmaceutical Industry.

Colégio da Indústria da Ordem dos Farmacêuticos. 2001

Qualified Person status recognized by the Portuguese Health Authority (INFARMED, registration nr. 10775).

Post-Graduation in Industrial Property.

Faculdade de Direito da Universidade de Lisboa. 1999

MSc in Pharmaceutical Sciences (5 years + 1 year for Thesis)

Faculdade de Farmácia da Universidade de Lisboa, Portugal

1989

MEMBERSHIPS

• American Society for Quality (Nr. 634227074).

• Colégio da Indústria da Ordem dos Farmacêuticos (Nr. 0441).

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Júlia C. Oliveira, MSc

• Controlled Release Society.

• European Society for Neurochemistry (ESN).

• ISPE – Engineering Pharmaceutical Innovation (Nr. 232814).

• Ordem dos Farmacêuticos (Profissional Card nr. 10337).

• Qualified Person Association (Membership card number: 185165).

• Qualified Person status recognized by the Portuguese Health Authority (INFARMED,

registration nr. 10775).

• Sociedade Portuguesa de Bioquímica.

AWARDS

• Award for The Best Six Sigma Project of 2007, by Escola Superior de Tecnologia e Gestão de Leiria.

FELLOWSHIPS

• Fellowship from the Calouste Gulbenkian Foundation (1983 – 1989).

• Research grant from the Calouste Gulbenkian Institute to neurochemistry studies (1989 – 1990).

• Research grant from the Junta Nacional de Investigação Científica e Tecnológica to pursuit with

neurochemistry research studies (1991 -1993).

R&D PROJECTS SUPPORTED BY EU PROGRAMS

• StemLine – Development of a Dermatology Product Line based on Synthetic Peptide Fragments

Growth Factors of Stem Cells. SINDEPEDIP - Regime de Apoio à Investigação e Desenvolvimento -

Acção A (Project SIIDT nr. 24754) (2012 – 2014).

• PROTMAL – Operational Program of Community Initiative IC-PME – Proj. nº L0101 (1999 – 2001).

• Aerosols of powder for Inhalation” - SINDEPEDIP - Regime de Apoio à Investigação e

Desenvolvimento - Acção A (Proj. 25/00384) (1998 – 2000).

• Biodisponibility Relative of Omeprazole After Multiple Administrations” - SINDEPEDIP - Regime de

Apoio à Investigação e Desenvolvimento - Acção A (Proj. 25/00385) (1998 – 2000).

• IMUNOPOR – Project of Development of Immunological Products in Portugal” – PEDIP II –

Projectos Mobilizadores para o Desenvolvimento Tecnológico (Proj. 25/00254) (1996 – 2000).

• Development of Pellet Pharmaceutical Formulations - SINDEPEDIP - Regime de Apoio à

Investigação e Desenvolvimento - Acção B (Proj. 25/00117) (1995 – 1998).

• Development of a Slow Release Formulation of an Anti-anginal Drug” - SINDEPEDIP - Regime de

Apoio à Investigação e Desenvolvimento - Acção B (Proj. 25/00118) (1995 – 1997).

PATENTS

• US 7 494 668 - Fast Water-Dispersible Domperidone Tablets (2009).

• EP1 634 586 - Fast Water-Dispersible Domperidone Tablets (2007) (with extensions to 28

countries).

• EP 1 108 425 - New Stable Multi-unitary Pharmaceutical Preparations Containing Benzimidazoles

(2005) (with extensions to 19 countries).

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Júlia C. Oliveira, MSc

• EP 1 108 431 - Gastroresistant Multi-unitary Pharmaceutical Preparations Containing Piroxicam

(2003) (with extensions to 19 contries).

• US 6,379,705 - Stable Multi-unitary Pharmaceutical Preparations Containing substituted

Benzimidazoles (2002).

• US 6,391,341- Gastroresistant Multi-unitary Pharmaceutical Preparations Containing Piroxicam

(2002).

PUBLICATIONS AS FIRST AUTHOR

• Oliveira, J.C., “Formulações Farmacêuticas sob a forma de Pellets – Desenvolvimento de uma

Formulação de Pellets de Piroxicam de Libertação Entérica” – Thesis presented to obtain the Title

of Specialist in Pharmaceutical Industry (2003).

• Oliveira, J.C., M.D. Constantino, A.M. Sebastião e J.A. Ribeiro. Ascorbate/Fe3+-induced

peroxidation and inhibition of the binding of A1-adenosine receptor ligands in rat brain membranes.

Neurochem. Int., 26 (3), 263-268 (1995).

• Oliveira, J.C., A.M. Sebastião e J.A. Ribeiro. On the high affinity binding site for [ 3H]-1,3-

dipropyl-8-cyclopentylxanthine in the frog brain membranes. Br.J.Pharmacol., 109, 518-523 (1993).

• Oliveira, J.C., A.M. Sebastião e J.A. Ribeiro. The frog brain possesses one binding site for [ 3H]-

DPCPX different from the A1 or the A2 adenosine receptors. Br.J.Pharmacol. (Proceedings

Supplement), 176P (1992).

• Oliveira, J.C., A.M. Sebastião e J.A. Ribeiro. Binding properties and molecular weight of the A 3

adenosine receptor in the frog brain membranes. Neurochem.Int., 21 (Supplement), C6 (1992).

• Oliveira, J.C., A.M. Sebastião e J.A. Ribeiro. Solubilized rat brain adenosine receptors have two

binding sites for [3H]-1,3-dipropyl-8-cyclopentylxanthine. Nucleotides & Nucleosides, 10(5), 1135-

1137 (1991).

• Oliveira, J.C., A.M. Sebastião e J.A. Ribeiro. Solubilized rat brain adenosine receptors have two

high affinity binding sites for 1,3-dipropyl-8-cyclopentylxanthine. J.Neurochem., 57, 1165-1171

(1991).

• Oliveira, J.C., e J.A. Ribeiro. Solubilized proteins from rat brain membranes have two binding sites

for [3H]-L-phenylisopropyladenosine. Eur.J.Pharmacol., 183(2), 485 (1990).

TECHNICAL AND SCIENTIFIC ADVISOR OF GRADUATE AND/OR PhD THESIS.

• PhD Thesis of Tânia Isabel Sousa Caetano at the scope of Characterization of a New Synthetic no-

Ribosomal Peptidic Antibiotic (NPRs): Development of New Peptide Antibiotics Changing Amino

acids Specificity” (2007 – 2011).

• PhD Thesis of Hugo Ortolá Serra, at the scope of Development, Application and Validation of Models

in vitro for Evaluation of the Biodisponibility and Bioequivalence of Drugs – co-supported by FCT

and Medinfar (2006 - … ).

• BSc Thesis in Pharmaceutical Sciences of Renata Veiga da Fonseca, Brazilian student from Curitiba,

at the scope of Manufacturing (Solid, liquid and ointment dosage forms), Quality Control and

Quality Assurance (ISO 9001:2000) (2004).

• BSc Thesis in Pharmaceutical Sciences of Jesuino Lima Bisneto Brazilian student from Curitiba, at

the scope of Manufacturing (Solid, liquid and ointment dosage forms), Quality Control and Quality

Assurance (ISO 9001:2000) (2003).

• BSc Thesis of Paula Alexandra Amaral Mota, concerning “Optimization of the Condition to

Lyophilize Pharmaceutical Dosage Forms for Oral Administration”, presented at the Faculdade de

Ciências to conclude Graduation in Technological Physics (1998).

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Júlia C. Oliveira, MSc

• BSc Thesis of Carla Patrícia Gonçalves Mendes, concerning “Optimization of Pellet Formulations”,

presented at the Instituto Superior Técnico to conclude Graduation in Materials Engineering (1997).

Last update: March 2014v01

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Júlia C. Oliveira, MSc

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