Formulation & Drug Product Development Technician (Devices)

At mAbxience, a company specialized in the development and manufacturing of biosimilar medicines, we are hiring a Formulation & Drug Product Development Technician for our Manufacturing Site in León (Spain).

General Responsibility

Responsible for proper execution of drug product and device development activities of biologic molecules. Lead chemical and physical analyses in support of biopharmaceutical product development. providing analytical support for drug product and device development. Prioritizes group tasks and manages resources to meet organizational goals.

Specific Responsibilities

• Contribute to a diverse set of projects, for a wide range of biosimilar biomolecules, including antibodies and non-antibodies.
• Evaluate drug product and device development activities and assist fill & finish activities.
• Conduct laboratory tests and procedures in accordance with GLP, cGMP, and SOP standards and accurately analyse scientific data with precision.
• Perform assigned analytical tasks with minimal supervision to drug product and device development activities.
• Perform analytical tests and procedure on candidates for biological drugs, particularly, but not limited, to CCIT, FlowCAM, Stoppering & Assembly machine, Microscope FTIR, Rheometer, UTT machine (for medical devices).
• Support the development, qualification, and validation of analytical methods specific based on the Formulation and Drug product development department.
• Identify technical challenges and effectively trouble-shoots any instrument problems
• and suggests and implements areas for improvement.
• Timely and efficiently prepare detailed study protocols, SOPs and technical reports.
• Actively contribute to the maintenance of Formulation and Drug product development laboratory organization and equipment.
• Train staff on laboratory procedures when required.

Requirements and personal skills

Mabxience is a company committed to equal opportunities, and therefore, all candidates will be considered without distinction of race, color, gender, age, sexual orientation, religion, origin, marital status, citizenship, or disability.