ROMELL TRUJILLO
Sunrise, Florida (*****)
Phone: +1-954-***-**** Email: **************@*****.***
Linkedin: linkedin.com/in/romelltrujillo
Project Manager for Development and Manufacturing
Project Management, Portfolio, Regulatory, R&D and Team Leadership
Bilingual Regional Project Manager in the Pharmaceutical Industry with proven expertise in Product Development for Rx (Teva) and OTC (Procter & Gamble, P&G, PGT), managing submission of new products from Design to Commercialization, by leading in-house developments, third-party and leveraging files from projects developed for USA and Europe, for submission in strategic markets in International Markets (Brazil, Mexico, Argentina, Chile, Peru, Venezuela).
Acting as business strategy partner with Marketing, Sales, Customer Service, Operations, Quality and Supply to provide technical feedback (feasibility, quick timelines and costs) for early evaluation of innovative ideas and/or implementation of new technologies.
Leading the execution of 100+ technical projects at local/regional level, under a fast-paced environment; adapting them to new business needs, resources and financial analysis.
13+ years of management experience within a multi-cultural and cross-functional environment, by inspiring people from different background and languages (English, Spanish, Portuguese), fostering clear communication with respect, sense of ownership and team-work.
Presenting monthly global project reports to stakeholders by translating complex information into single actions to promote high impact decisions and avoid delays.
CORE SKILLS
Project Management / Business acumen / Imaginative / Smart and Strong Leadership Ability / Self-discipline to work independently / Ability to Multi-Task, organized leader / Cross-functional / Coaching, mentoring and delegation / Communication skills / Influence and Respect / Project Planning / Pharmaceutical Market Experience / Research and Development (R&D) formulation / Rx, OTC / Microsoft Office
PROFESSIONAL EXPERIENCE
TEVA USA (TEVA PHARMACEUTICALS) 2013 – 2018
Miami/Fort Lauderdale Area, Florida Project Manager IV for Latam – Rx
Regional Project Manager (R&D Portfolio) accountable for timeline management for Latam within a multicultural and multidisciplinary environment of project sourcing from Latin America, USA and Europe
Submitted 30+ new products/year in Latam.
Implemented a SharePoint platform linked to an automated Excel sheet to generate the regional/global reports: Latam, India, South Africa, Israel, Russia and Asia key countries. This system ended up in reducing by 50% the time spent gathering data from 150+ projects.
Led a 6-month-review and implementation of quality improvement process and execution of a remediation plan for 13 reformulation projects in Mexico (after Teva’s acquisitions).
PGT HEALTH CARE (JOINT VENTURE TEVA P&G) 2013 – 2017
From Miami, to support Panama’s HQ R&D Project Leader for Latam - OTC
Led R&D regional development of OTC products, working with various functions: Product Portfolio, Marketing, Regulatory, Sales support, Retail Supply Chain, Quality, and Operations (Manufacturing/Packaging).
Monitored 10+ regional PGT projects to ensure deliverables are aligned to the approved project scope from our parent companies: P&G, Teva.
Partnered with Commercial/Marketing to customize new products to meet customer needs.
Submitted 6 OTC products: Brazil (3), Chile (3), full developed, including stability studies protocols, validation, and bioequivalence, under a multi-country network (USA, UK, Brazil, Chile, Panama, India and Germany).
Run strategic due diligences and regulatory inspections (with QA/RA/OPS) to third-party development and manufacturing companies.
TEVA PERU S.A.C. Lima, Peru 2000 – 2013
R&D Manager
Managing (as leader and mentor) a 22-highly motivated team-members, to develop new products from concept to the Market.
Submitted 10+ new products/year, average.
Led the design, planning, development, validation, scale up and technology transfer of new products, line extensions and analytical methods to Operations and Quality.
Promoted continuous improvement and innovation by fostering the use of latest excipients/technologies to launch unique formulations.
Led ad-hoc meetings with Marketing / Commercial to provide technical support and share ideas/proposals for new products, as well as support the timely product launches program.
Implemented a mindset to think-out-the-box within the framework of our Global Policies and Procedures.
Prepared, executed the R&D’s budget management for the next 3 years (planning and forecasting reports).
TEVA PERU S.A.C. Lima, Peru 2000 – 2001
Oral Solid Dosage – Manufacturing and Packaging Chief, Rx, OTC
Managing all the manufacturing and packaging activities for Oral Solid Dosage forms at Industrial Scale.
Leading the Production Department in prioritizing manufacturing to ensure on-time delivery.
Implemented the ‘Organic Solvent Reduction’ to all the coating process in less than 14 months, to improve personal safety and production environment.
Led the switch process of using ‘Direct Compression and/or Aqueous Granulation’ and removing gradually all the ‘Organic solvent granulation’.
Promoted the use of Aclar/PVC to protect instable formulations from Zone IVb (Stability Studies).
EDUCATION
Master’s Degree (studies concluded), Experimental Pharmacology
Universidad Nacional Mayor de San Marcos, Post-Graduate Studies, Lima, Peru
Bachelor of Pharmacy, Pharmaceutical Sciences
Universidad Nacional Mayor de San Marcos, Fac. Pharmacy & Biochemistry, Lima, Peru
PROFESSIONAL DEVELOPMENT
Project Management Institute (on-going training for PMP)
Leadership Development
PROFESSIONAL AFFILIATIONS
AAPS (American Association of Pharmaceutical Scientists)
PMI (Project Management Institute)
CERTIFICATES / LICENCES
In-house: Competing Fairly and Conducting Business with Integrity (Oct’17)
In-house: PLM Certification (Sep’17)
In-house: Clinical Safety Adverse Event Reporting (Jan’17)
In-house: Other trainings in Documentation and Standard Operating Procedures (2000-2018).
SOFTWARE
MS Office (with improved skills on Excel). Planisware- Product Lifecycle Management (PLM), BI-Cognos, PS-Next and MS Project.
LANGUAGES
English (fluent) – Spanish (native) – French - Portuguese.