Business Development Operations Manager

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CURRICULUM VITAE

Dr. Mohamed Mbarki PharmD, Msc, MBA.

Business Development

Operations Manager

Pharmacist-Qualified Person.

Pharmaceutical Sciences Expert (CMC, MST, QARA).

• Address : Sousse, Tunisia.

• Birth : July1985.

• E-mail : ******.*@*******.***

• Mobile : +216-**-***-***.

15 years experience on pharmaceutical manufacturing Operations (MST, R&D, Quality).

5 years on pharmaceutical Business Development.

ACADEMICS RECORD

2024 - 2026 * Healthcare Policy & Management Master Program / Medical School of Sousse, Tunisia.

2022- 2023 Private Equity: Financing, Investing and Value Creation / Business School, Imperial College of London.

2011 - 2012 Drug Development Master Program / Pharmacy School of Monastir, Tunisia. 2004 - 2011 PharmD degree / Pharmacy School of Monastir, Tunisia. WORK EXPERIENCE

Sep2018-Dec2023

Berg-Life Sciences

Technical Operations & Business Development Director

– Investment relations / opportunities Manager : Business Modeling, Financing Search.

– New projects Management: Parenteral manufacturing site project management

(Budgeting, Process Design, Equipment URS elaboration, Supplier Offers Validation, Project coordinating).

– Drug products Portfolio Management: coordinating tech-transfer to new sites.

– Regulatory affairs and Clinical Trials studies : Budgeting, Coordinating.

– Market Access : Pricing, Tenders Management.

Apr2015-Aout2018

Qatar Life Factory

Authorized Person-Quality Unit Manager

– Batch Release for all medicinal products.

– Ensuring compliance of Quality System to international guidelines.

– Ensuring adequate application of the Quality System.

– Ensuring Science based approaches of all Manufacturing Process and Development.

– Ensuring Operations Compliance to local legislation.

– New Products launch : Bench-scale, scale-up, ToT, Validations.

– Head of Transfer of Technology committee.

– Personnel training and management.

Oct2013-Fev2015

Alliance Pharma

Technical Operations Manager

– Management of pharmaceutical manufacturing & development operations.

– Formulation of new drug product / Manufacturing process design/ Pilot batches manufacturing.

2

Dec2012-Sep2013

Opalia Recordati

Senior Project Manager

– New drug product formulation (semi-solid forms, DPI), scale-up and manufacturing process problems investigation.

– Outsourcing operations management.

– Evaluation of CTD file, MAA submission process supervision. Fev2011-Dec2012

Adwya

Junior Project Manager

– CTD file elaboration.

– Responsible for new project’s CMC development.

– New drug product formulation (solid dosage forms, parenteral).

– Assistance on manufacturing and scaling.

PROFESSIONAL & SOFT SKILLS

Business development :

· Products Portfolio Management.

· Strategic Business Development & Business Intelligence.

· Financing opportunities hunting.

· Cooperation opportunities exploration.

Project & Operations Management:

· Budgeting.

· CAPEX Management.

· Strategic plans for site development.

· Industrial operations management, OPEX management.

Relations Management:

· Outsourcing activities development and coordination.

· Regulatory bodies relations management.

· B2B opportunities exploration.

· CAPEX opportunities development and negotiation.

Quality Management :

· Confirmed skills as per GMPc, ICH, WHO’s and PIC/S recommendations.

· Understanding of diversified Quality concepts: TQM, GAMP-5, ISO 9001, 6-Sigma concepts.

· Site Compliance insurance as per local and International regulations (FDA, EMEA, MHRA, ICH, ASQ) and technical recommendations (ISPE, SFSTP).

· Quality investigational tools (CAPA, FMEA, HACCP, RCA, A3 analysis, FTA).

· Good understanding of process improvement tools (Lean management, VSM, 6-sigma, PHA).

Pharmaceutics Sciences :

· Experience with Biosimilars transfer of technology.

· Confirmed hands-on experience with analytical chemistry techniques (HPLC, MS, NMR).

· Pharmaceutical statistics and basic sciences application (chemistry, Maths, Galenics, Material Sciences, Biologics Filtration, Coating, Granulation, Tabletting, CIP-SIP, Sterilization).

· Confirmed experience with solid dosage forms, parenteral/Aseptic process: direct working, personal advices and supervision, process problems solving, operational quality assurance.

· Aseptic Processing transfer, line/process validation-inspection.

· Solid, semi-solid and parenteral dosage forms formulation, bench scale, pilot batches, scale-up and industrial manufacturing; Pre- formulation studies / formulation screening / Technology transfer and process validation.

Regulatory Framework Management :

· Regulatory guidelines surveillance.

· CTD file elaboration, inspection and review.

· Hands-on with registration with EU market.

3

Soft Skills :

· Equilibrated hiring strategy.

· Personnels training, motivation and conflicts management.

· TQM approach instauration : Leadership, Personnel Implication. ACADEMICS RESEARCH

– In vivo bioavailability comparison (Glimepiride as API): 3 months training at Siphat laboratory, 2009.

– New drug delivery system (master program project: Fusidic Acid based nano-suspension formulation, 2012).

IT TOOLS

– MS Office, MS Project, ERP SageX3, SPSS, Python. LANGUAGE

– Arabic : Native.

– English : Bilingual.

– French : Bilingual.

– German : A1.

ENTERTAINMENT

– Sport: football, walking.

– Reading: history, Politic, business/entrepreneurial management.

– Internet : hand-craft applications, Documentary.

– Intellectual : Chess, paper games.

– Social Activities: charity (orphans associations, Tunisian Red Crescent volunteer & sponsor).

Contact this candidate