MST & Project Manager

Descripción de la oferta de empleo

Perfil buscado (Hombre/Mujer)


MST & Project Manager, ESO Owns technical stewardship of FDF products (E2E oversight of manufacturing process & technology, specifications, validation & continuous improvement), support regulatory with filing/maintenance questions, QA support with troubleshooting customer/supplier matters all in coordination with CDMO/CRO´s and other company departments. Owns & leads technology transfers as part of network optimization/portfolio expansion plans and responsible for project team.

The main activities and responsibilities
• General: Represent the technology function in ESO with coordination across the company and 3rd parties. Build and maintain an adequate external network to deliver on customer commitments and long-term growth plans. Acts as SPoC & SME across the company on all product, process & technology related matters in compliance with industry regulatory/quality guidelines.
• Operational: accountable for ensuring the portfolio is maintained in a validated/compliant status across the product lifecycle. Develops portfolio risk assessment and implements annual continuous improvement plans for marketed portfolio. Technical coordination/support with CDMO/CRO & Centrient departments across product, process, specification & technology, related to Regulatory maintenance/new filings, Quality action points/troubleshooting and root-cause/CAPA of production issues.
• Tech transfer & network due- diligence: Project lead for assigned dossier/tech transfers across FDF manufacturing network. Accountable for delivering against business case mandate across the entire project scope (e.g. technical protocol development, AMT, engineering batches, scale-up/validation & dossier submission). Responsible for coordinating a cross-functional project team, their deliverables and reporting status through governance. Responsible for providing technical due-diligence support on portfolio/asset acquisitions and evaluation of new to network CRO/CDMO´s.
• Shared responsibility in cross-functional Teams within ESO & FDF organization
• Give Technology support to own FDF Development Team and other disciplines, company-wide within the company
• General compliance
• Being responsible for budget/cost, timeline, and risk management of assigned technical projects

• Tech transfer, scalability, validation, compliance, regulatory, manufacturing|Finished Dosage Forms (FDF) & CMOs
• At least 6 years of experience in Pharmaceutical Technology, preferably in Generics.
• Academic degree (MSc) in Technology, Pharmacy, Biochemistry or related field. Advanced degree preferred.
• Broad, multidisciplinary experience.
• Professional English level (company official language)
• Well-trained in all relevant Quality and SHE policies and procedures.
• Managerial and social knowledge and experience.
• Having extensive experience in pharmaceutical production (Test to Pilot to Full-scale).
• Having experience in analytical chemistry.
• Having extensive experience in collaborations with (international) third parties.
• Having experience in bringing generics to the Market.
• Customer and external focus.
• Drive for results.
• Improve, Innovate and Change.
• Engage People.
• Act Responsibly.
• Passion for success and driving results
• Improve, Innovate and Change
• Flexible, agile, proactive with a "never give up" type of mindset
• Customer and external focus
• Structured, Analytical, Creative
• Collaborating cross-functional, both internally and with 3rd parties, Engage People


API Multinational Company

• Multinational environment
• Fix contract
• Barcelona based but open for international home office
• Great salary package

Otros detalles de la oferta

Datos principales de la oferta

• Barcelona - España
  Ubicación
• Jefe de Proyecto
  Funciones
• Jornada completa
  Jornada
• 3-5 años
  Experiencia
• Indefinido
  Tipo contrato
• QA Project Manager