Sponsor Project Manager
Resume:
Industrial pharmacist with +** years’ experience on drug product manufacturing, analysis, pre-formulation
and formulation.
Looking for position as Pharmaceutical Operations Management / Projects Management / R&D and Regulatory affairs management.
Academic Year Diploma/ Institution
2020 - Master Degree in Management and strategic Business Intelligence (ongoing).
2011 - 2012 Pharmaceutical Development master program / Faculty of Pharmacy of Monastir, Tunisia. 2010 - 2011 PharmD degree / Faculty of Pharmacy of Monastir, Tunisia
2003 - 2004 Baccalaureate degree (mathematics section, Good Grade)/ Tunisia.
Work Experience
Duration
Company/Position/Responsibilities
September 2018
Berg-Life Sciences/Tunisia: Technical Operations And Business Development Director
-Equity Research, Investment opportunities Manager.
-New projects management: new parenteral manufacturing site project management (Budgeting, project coordinating).
-New drug products introduction: coordinating tech-transfer to new sites.
-Regulatory affairs and Clinical Trials studies coordinating.
-Registration and Export coordinating.
November 2017 to September 2018
Qualified Person, Senior Pharmaceutical CMC consultant:
-Senior Consultant as Project Manager: Start-up, new product launch, tech-transfer (Assistance of pharmaceutical companies on Process validation, problems solving, MAA submission)
-Personal training on technical guidelines, pharmaceutical basic operations/Process,
April 2015 to September 2017
Qatar Life Factory/Doha-Qatar: QC Manager-Authorized Person
-Approval/authorization of QC department’s SOP, Product quality profile approval, regulatory documentation review/approval.
-Laboratory auditing for Quality-Regulatory compliance, Laboratory PT scheme design and monitoring, QC staff training.
-Reviewing QA documentation, Assistance on internal audit and QA investigation.
-Production BMR review, change control review, PVP review.
-Head of technology transfer committee, leading external audit, new project implementation.
-Product release (Intermediate, Finished Product).
-Member of negotiation/consultancy team on new project.
10/2013 to
02/2015
Alliance Pharma/ Sousse-Tunisia: Technical Operations Manager
-Supervision of pharmaceutics’ development operations.
-Formulation of new drug product / Manufacturing process design/ Pilot batches manufacturing.
-Industrial Manufacturing: scale-up, validation, adoption to equipments.
12/2012 to
09/2013
Opalia-Recordatti/ Ariana-Tunisia: Senior Project Manager
-New drug product formulation (semi-solid forms, DPI), scale-up and manufacturing process problems investigation.
-Evaluation of eCTD, MAA submission process supervision.
04/2011 to
11/2012
Adwya/Tunis-Tunisia: Entry level Project Manager - eCTD elaboration (3.2.S and 3.2.P parts).
-Responsible for new project’s analytical part validation.
-New drug product formulation (solid dosage forms), assistance on manufacturing and scaling.
-Project management: Budgeting, Business development, project realization stream-map’s design and coordination, OPEX management, strategic thinking capacity.
-Private equity opportunities search and evaluation of financial experts’ counseling.
-Industrial operations management: KPI development, statistical applications.
-Soft and International relations management: Outsourcing activities development and coordination, regulatory bodies relations management, B2B opportunities exploration, CAPEX opportunities development and negotiation.
-Confirmed skills as per cGMP, WHO’s and PIC/S recommendations.
-Confirmed experience on analytical chemistry, pharmaceutical statistics and basic sciences application.
-Perfect understanding-application of pharmacopeia texts and Product quality profile review as per diversified regional and international regulations.
-Documentation review as per international regulations (FDA, EMEA, MHRA, ICH, ASQ) and technical recommendations (ISPE, SFSTP).
-Confirmed experience with quality investigational tools (CAPA, FMEA, HACCP, RCA, A3 analysis, FTA).
-Good understanding of process improvement tools (Lean management, VSM, 6-sigma, PHA).
-Confirmed experience with solid dosage forms, parenteral/Aseptic process: direct working, personal advices and supervision, process problems solving, operational quality attention.
-Aseptic Processing transfer, line/process validation-inspection (Media fill, SIP-CIP, Personal training).
-Confirmed skills on solid dosage form granulation (Wet/Dry) and coating process/formulation optimization.
-Solid, semi-solid and parenteral dosage forms formulation, pilot batches, scale-up and industrial manufacturing; Pre-formulation studies / formulation screening / Technology transfer and process validation.
-Confirmed experience with eCTD dossier review, correction and MAA process supervision (EMEA, FDA applied regulations), project management.
-Various experiences with HPLC methods modification, validation (chemical and biologic matrix).
-Understanding of diversified Quality concepts: TQM, GAMP-5, ISO 9001, 6-Sigma concepts.
-Multi-factorial industrial operations management applied to pharmaceutical manufacturing.
-Initiation with German drug regulations (AMG, AMWHV) and German pharmaceutical terminology (Ability to adapt with German speaking environment).
-In vivo bioavailability comparison (Glimepiride as API): 3 months training at Siphat laboratory, 2009.
-New drug delivery system (master program project: Fusidic Acid based nanosuspension formulation, 2012).
-Paper reading: Innovative drug delivery system for poorly water-soluble drug candidates / Biopolymers in drug delivery systems / Quality Management Guidelines.
-ERP sageX3, SPSS 18.0, MS Project, ChemBio (chemical modeling), MS office.
Arabic (native speaker)/ French (bilingual) / English (fluent)/ Deutsch (basic, short discussion).
-Sport: football, walking.
-Reading: history, Politic, business/entrepreneurial management, hand-craft applications.
-Chess, documentary movies, traveling.
-Social Activities: charity (orphans association, Tunisian Red Crescent/ International Red Cross volunteer sponsor).
Contact this candidate