Pablo Gamboa

Experience

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  Kylolab, S.L.

  Jan 1997 - Feb 2009

  Still Head of the Quality Unit and Qualified Person, became the Head Project Manager and Deputy GM.• Directed and managed the improvement of the QMS from ISO to GMP compliance.• Accountable for all Quality activities, including QMS ISO/GMP compliance, audits, etc.• Projects Manager coordinating R&D, Quality, and Production Units.• Person of contact for all customers.MSA: The development of a customer’s novel clinical test for lactose intolerance, holding meetings at the Spanish Medicines Agency to ensure safety and GMP compliance. Weniger anzeigen

  • Project Manager / Qualified Person / Legal Representative

    Apr 2007 - Feb 2009

  • Head of Quality Unit & Legal Representative

    Apr 2001 - Apr 2007

  • Head of Quality Unit

    Jun 1999 - Apr 2001

  • Research Chemist & Analyst

    Jan 1997 - Jan 1999
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  Derivados Químicos, S.A.

  Feb 1997 - Jan 1997

  Analyst

  Oversaw the analysis of raw materials, intermediates, and finished API's. Edited CoA's. Became deputy QC manager.MSA: Mastering HPLC & GC analyses (including handling and maintenance of chromatographs).

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  Bayer AG

  Jan 1999 - Apr 1999

  Chemist in Practice

  R&D lab, Analytical development lab, ZeTO plant (pilot plant).Technical link between Kylolab and Bayer, responsible for the implementation of Bayer's procedures and philosophy in Kylolab.

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  CCOO

  Sept 2005 - Jul 2010

  Trainer

  Chemical plant operators courses on health and safety, basic operations, and chemistry.

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  Ministerio de Trabajo e Inmigración

  Jan 2008 - Feb 2009

  Technology Expert

  Working with SPEE for the elaboration of the national Professional Certificate (Level 2) for the Manufacture of Pharmaceutical and Similar Products, published as Annex II to the Royal Decree 719/2011, on 20 May (BOE, 23 June, 2011).

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  EEN - Escuela Europea de Negocios

  Jan 2009 - Jan 2009

  Lecturer

  Lecturer on "Improvement Tools", part of the Master en Integración de Sistemas de Gestión (Management Systems Integration).

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  Kylolab, S.L.U. - INFA Group

  Feb 2009 - Feb 2010

  Managing Director

  Led the integration of Kylolab into the Infa Group. Contact person in the company with direct reporting line to the Group’s President & CEO.• Acted as legal representative and business developer (CPhI, Informex, Chemspec).• Was project manager and responsible for all customer relationsMSA: Successful integration of Kylolab within the Infa Group, coordinating projects and teams.

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  Derivados Químicos, S.A. - INFA Group

  Feb 2010 - Jan 2010

  Marketing & Sales Manager

  Monitored Spanish API market and was responsible for the business development and marketing activities for Derivados Químicos.• Evaluated the technical and financial aspects of new projects.• Acted as project leader for new projects, taking part in project meetings with customers.• Attended Pharma industry events, like Informex, CPhI, and ChemSpec.MSA: The coordination of the first cryogenic (-90ºC) project at 200 kg scale. Collaborated with the customer to apply for the corresponding US EPA authorisations. Weniger anzeigen

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  Desarrollo Químico

  Nov 2010 - Jan 2010

  Private consultant

  Optimization of industrial processes (pharma industry).Upscale of chemical processes.Project development and management.

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  Synthetics International AG

  Jan 2011 - Jan 2011

  Head of R&D

  Responsible for the corporate R&D unit. Based in Jiangsu (China), directed and coordinated all new projects, allocating resources (ca. 30 people in lab and plant), prioritizing projects and activities, and periodically communicating with customers (mainly from US, but also from Europe) on a commercial and technical basis. Worked with 100% Chinese staff. Accountable for lab and pilot plant activities, and for industrialization of new projects.• Channelled requests for R&D, setup and checked adherence to timelines and milestones.• Introduced new synthesis concepts process upscale and transfer.• Evaluated existing products for improvements, setting timelines and milestones.• Ensured that Production Dept. could operate procedures from R&D and Pilot, supporting operational improvements.• Trained and coached higher level managers.MSA: The development and successful up-scale of an advanced intermediate for a Phase III drug, leading the local Chinese team to meet the expectations of our US customer. Also became involved in the sourcing of the key raw material for this customer. Weniger anzeigen

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  Synthetics China Co., Ltd.

  Jan 2012 - Nov 2015

  Business Development Manager for Europe & US

  Responsible for the business development activities for active pharmaceutical ingredients (API’s) and intermediates in Europe and US markets. Establish and keep relationships with key persons in large pharmaceutical companies. Serve as only point of contact with customers for resolution of high-profile issues, both technical and commercial. Coordinate marketing and sales activities.• Integrated new customers in the company’s portfolio, expanding the company’s client base.• Renewed company portfolio through agreements with customers diversifying the risk: long-established projects with predictable sales, Clinical Phase III projects, and developments for products to become generic drugs in 3-5 years.• Defined collaboration framework with customers project-wise, opting for tolling, sharing risk, or developing the IP, attending to customers’ preferences and market information.• Took over the major projects as project manager.• Led projects internally and acted as contact person for foreign customers.• Supported production management system to improve productivity and product life cycle.MSA: Attracted new customers (from Europe and US) to the company, diversifying the type of customer (big pharma, CRO, trader, etc.), size of project (10 kg to +300MT), and type of collaboration (partnership, tolling, etc.). Weniger anzeigen

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  MORCHEM China

  Jan 2015 - Nov 2018

  General Manager

  Responsible for setting up and managing Morchem office in China, leading all activities of Morchem Group in China, Japan, Taiwan, and South Korea.• Establishment of the company in Shanghai.• Recruit and management local employees, especially in the commercial and technical teams.• Monthly financial and commercial reporting.• Support headquarters in sourcing and qualification of raw material.MOST SIGNIFICANT ACCOMPLISHMENT (MSA): Creation of the legal and operational structure to import and market Morchem speciality products (including dangerous goods) in China. Weniger anzeigen

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  Vidara Switzerland AG

  Jan 2018 - now

  • Pharma Strategy Director & QP

    Jan 2023 - now

  • Pharma Strategy Director & Qualified Person

    Jan 2019 - Jan 2023

  • Strategic Global Pharma Director

    Jan 2018 - Jan 2019