Marlene Monteiro
Sittard,Netherlands
Summary
More than 30 years’ experience in Pharmaceutical Industry and more than 15 years’ experience in Program/Project Management.
Biologist and Pharmacist by training, with Master of Sciences degree (MSc) in Pharmacy and equivalent degree in Biology.
Strong leadership, stakeholders management and communication skills dealing with multi-site and multifunctional teams, customer and top management. Proven experience in successfully deliver projects of several pharmaceutical areas and lifecycle: small and large molecules of drug substance and drug product (oral, injectable, inhaled).
Specific areas of work: biotechnology (cell and gene therapy), small molecules (including process development chemistry), inhalation development, spray drying and sterile drug products.
Highly customer and results driven in a fast-pace environment, ensuring that project milestones are met.
Focus in internal and customer KPIs achievement, contributing actively to the business growth.
Overview
33
33
years of professional experience
1
1
Certification
Work History
Associate Director Program Management
Lonza
2022.01 - Current
- Project Management of Contract Development and Manufacturing Organizations (CDMO) - Cell and Gene Therapy (CGT), both autologous and allogenic products.
- Lead of projects from Technical Transfer to Commercial, including expansion / scale-up.
- Projects lead for launch and approval by FDA, EMEA, MHRA and middle East Asia (e.g. UAE and KSA) - effectively accomplished.
- Strong leadership skills in a matrix environment with cross-functional teams Quality Control, Analytical Development, Manufacturing Operations, Supply Chain, Quality Assurance, MSAT, Regulatory Affairs, Account Management, Proposal Management and other relevant areas.
- Stakeholders management, facilitating communication and collaboration across departments and customers (including the senior management).
- Monitors continuously KPIs included in commercial service agreements and liaise proactively with stakeholders to successfully achieve the objectives.
- Management of monthly invoices and sales recognition of projects with annual revenue of more than 60 million EUR.
- Customer satisfaction monitored against milestones on an annual basis with outcome of good to very good feedback.
- Proven experience in managing highly performance teams under a matrix environment.
- Internal Lonza evaluation in 2023 and 2024 as an 'outstanding' performer.
- Start working as Senior Program Manager at Lonza that transited to Associate Director, from 2022 onwards.
Senior Project Manager
Lonza
2020.05 - 2021.12
- Job description very similar to the 'Associate Director Manager' above.
Senior Project Manager
Hovione
Loures
2007.11 - 2020.03
- Progression of Project Management at Hovione: - 2018 - 2020 PMO Senior Project Manager - 2014 - 2018 Project Management in RD / Process Chemistry Development Group - 2007 - 2014 - Project Management in Pharma and in RD / Drug Product Development Group.
- Main Responsibilities and Professional Experience:
- - Team Lead with great focus in inter and intra communication (project teams, internal stakeholders and customers);
- - Management of Scope, Budget and Timelines, specific to the PM job function;
- - Management of projects mainly from USA, UK, EU (Hovione main customers);
- - Management of projects as CDMO that includes Proof of Concept, Phase I, Phase II, Phase III and Process Validation / Commercial clinical trials phases; the projects are related with both Drug Substance and Drug Product development; the products are essentially for oral and inhalation administration but injectable as well.
- - Experience in project management across projects life cycle, in the RD Drug Product and Process Chemistry Areas.
- - Planning, monitoring, executing and ensuring the completion of projects within a required / defined timeframe, with the required quality, aiming to meet customer satisfaction.
- - Implementing proposed / required changes into the project lifecycle, according to agreement between the relevant stakeholders and the customer.
- - Facilitator in technical risk assessments / problem solving with project teams and customers; mitigation plans implementation and reporting to the higher management levels (when needed).
- - Conflicts management with cross-functional project teams.
- - Scheduling of internal and external meetings and preparation of respective agendas and meetings minutes.
- - Periodic evaluation / written reports: projects status review (Key milestones, Deliverables, Timelines).
- - Work proposals support - scope review for ongoing projects and new scope review for new projects; change of scope management.
- - Continuous monitoring and update of deliverables and invoicing in CRM application.
- - Organization of face-to-face meetings with technical teams and customers; MS Power Point public presentations.
- - Project Management within a matrix organization, cross-functional links with the core teams (Process Development, Manufacturing, Quality Assurance, Quality Control, Sales) and with the supportive team members (Purchasing and Sourcing of Raw Materials, Logistics, Order Processing, Regulatory Affairs, Compliance, Regulatory Affairs, Process Safety Health, Safety and Environment, Marketing).
Microbiology Head
Hovione
Loures
1999.06 - 2007.10
- Line Manager of the Microbiology team group (included in the Quality Control Unit). Responsible for all microbiological analysis and release of drug substance and drug product (DS, DP).
- Microbial tests namely bioburden, identification of species and endotoxin content determination by both gel-clot and chromogenic methods.
- Microbiological monitoring of the water systems and environmental monitoring (operators, air and surface) as part of the responsibilities of the Microbiology Lab.
- All microbial methods validated according to USP, EP and JP monographies.
Microbiology Head
Hikma Pharmaceuticals
Sintra
1993.03 - 1999.06
- Progression of the Microbiology career at Hikma:
- 1993-1997 - Microbiology Analyst and Technician
- 1997-1999 - Head of Microbiology Lab Responsibilities
- Activities of the job: Line Manager of the Microbiology Lab team (part of the QC Group), responsible for the coordination of all the Lab activities, including performance evaluation and recruitment (analysts and technicians).
- Responsible for microbiological analysis/release of the final sterile dosage form (liquid and solid), namely sterility testing and endotoxin content determination.
- Sterile Drug Product manufactured by aseptic process filling.
- Validation of the microbiological methods for sterility and endotoxin testing.
- Media Fills assessment for the validation of the aseptic process simulation.
- Microbiological validation of the sterilization processes (dry heat sterilization, steam sterilization, liquid sterilization by filtration, UV Pass box loads).
- Testing of Sanitization / disinfection agents (IPA and other cleaning agents).
- Environmental Microbiological monitoring of all grade rooms - Grade A to Grade D (air, surfaces and personnel).
- Water systems analysis (WFI, PW).
- Important Milestones at Hikma: Started working when the first facility unit initiated manufacturing - small team with very demanding fast pace multi-tasking environment.
- 1997 - First FDA Inspection to the facility - high and crucial contribution for the successful of the FDA pre-approval - extremely active role as the company Microbiologist expert and high recognition by the Hikma Top Management.
Education
Master of Pharmaceutical Sciences - Pharmacy
Instituto Superior de Ciências da Saúde Egas Moniz
Monte da Caparica, Portugal09.2009
Biology equivalent to Master Degree -
Faculdade de Ciencias da Universidade de Lisboa
Lisboa, Portugal03.1995
First Certificate in English -
British Council
Lisboa, PortugalSkills
- Strong leadership
- Very good communication
- Strategic Planning
- Risk Management
- Cross-functional leadership
- Customer relationship building
Languages
Portuguese
First Language
English
Proficient
C2
Spanish
Beginner
A1
French
Beginner
A1
Custom Section
- PMI (Project Management Institute) IX International Conference of PMI Portugal Chapter, 2015-01-01, Lisbon, Lisbon, Portugal
- PMI (Project Management Institute) VIII International Conference of PMI Portugal Chapter, 2014-01-01, Lisbon, Lisbon, Portugal
- Annual Pharma PPM Toolbox, 2013-01-01, Basel, Switzerland
- Inhaled Drug Delivery, 2009-01-01, London, United Kingdom
- Project Management Institute Membership, 2016-01-01, 2020-01-01
Certification
CERTIFICATES & COURSES
- First Certificate in English - British Council, Portugal (Lisboa)
- Project Management PMP Certification Training Course in March 2019, Lumiar, Portugal, concluded successfully
- Workshop in "Business Analysis" in 2015, Lisbon
- "Project Leadership: High-Performance Teams" training in 2012 (London), concluded successfully
- "PMI - Project Management Fundamentals" training in 2009 (Lisbon), concluded successfully
- "PMI Microsoft Project I Planning" and "PMI Microsoft Project II Controlling", 2010, Lisbon trainings, concluded successfully.
- "Conflicts Management" and "Time Management" (2010) - Training at Hovione (external qualified consultants), concluded successfully
Conferences / Seminars and Memberships
- PMI (Project Management Institute) IX International Conference of PMI Portugal Chapter, Lisbon, 2015
- PMI (Project Management Institute) VIII International Conference of PMI Portugal Chapter, Lisbon, 2014
- Annual Pharma PPM Toolbox, Basel, Switzerland, 2013
- Inhaled Drug Delivery, London, UK, 2009
- Project Management Institute Membership, 2016-2020
Accomplishments
- Successfully delivered projects from tech transfer through commercialization, including global regulatory approvals (FDA, EMEA, MHRA, Middle East)
- Managed projects generating >€60M annual revenue
- Achieved strong customer satisfaction ratings based on KPI performance
- Recognized internally as “outstanding performer” (2023 & 2024)
Timeline
Associate Director Program Management
Lonza
2022.01 - Current
Senior Project Manager
Lonza
2020.05 - 2021.12
Senior Project Manager
Hovione
2007.11 - 2020.03
Microbiology Head
Hovione
1999.06 - 2007.10
Microbiology Head
Hikma Pharmaceuticals
1993.03 - 1999.06
Master of Pharmaceutical Sciences - Pharmacy
Instituto Superior de Ciências da Saúde Egas Moniz
Biology equivalent to Master Degree -
Faculdade de Ciencias da Universidade de Lisboa
First Certificate in English -
British Council