R&D Physical Properties Team Leader

Plan, coordinate, manage, advise, monitor, and report the advanced analytical characterization of development and life-cycle improvement projects, for active substances, excipients, finish dosage forms and respiratory products where applicable. Coordinating and controlling the different areas of her/his department involved in the required physical properties characterization; in order to achieve the development, launch and life-cycle improvements of products within the stipulated deadline with the required quality and ensuring the continuity of production.

Supervise, coordinate, and analyze the activities of the R&D Physical Properties, the technical work of each project and ensure that projects are undertaken in accordance with current legislation, Guidelines of Agencies, FDA, EMA, GMP regulations, and corporate objectives of the strategic quality annual plan.

• Responsibility for advanced analytical characterization of all Chemo’s portfolio of projects.
• Manage, plan and report on the overall advanced analytical characterization of projects to achieve their development and launch within the stipulated time, with the quality needed to ensure business continuity.
• Lead R&D groups for Physical Properties.
• Manage, coordinate, advise and control the assigned area for the development of projects and assess the resources, human and material, necessary to operate.
• Prepare and approve specific scientific documentation for quality and regulatory affairs to support projects assigned to R&D and to meet the standard approval flow established by the quality system.
• Serve as point of contact for advanced analytical characterization with relevant internal and/or external stakeholders in development programs to ensure the achievement of the agreed goals are met.
• Evaluate and advise, along with the areas of R&D on the needs of potential implementation and/or upgrade of advanced analytical techniques.
• Prepare the annual budget and needs assessment for both investment and human resources, and actively participate in the recruitment and development of the team.

• Education: Pharmaceutical degree or PhD in Pharmacy, Pharmaceutical Sciences, or related scientific degree in Chemistry.
• Languages: Very good level in spoken English and written communication. Spanish fluency is an asset.
• Experience (years/area): A minimum of 10 years of experience in characterization of physical properties and/or any other advanced analytical characterization of different pharmaceutical dosage forms.
• Specific Knowledge: Knowledge of GMP regulations and other relevant EU & US guidelines.
• Travels: Willingness to travel.