(PEK-444) | Formulation & Drug Product Development Technician

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 formulation and drug product development activities of biologic molecules. Lead chemical and physical analyses in support of biopharmaceutical product development, providing analytical support for formulation and drug product 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 protein formulated product and assist in drug product development / fill & finish activities.
• Conduct laboratory tests and procedures in accordance with GLP, cGMP, and SOP standards and accurately analyze scientific data with precision.
• Perform assigned analytical tasks with minimal supervision to support process development, formulation, stability studies, forced degradation, and product characterization.
• Perform physicochemical tests on candidates for biological drugs, particularly, but not limited to UV-Vis spectrophotometry; SoloVPE, pH, conductivity, osmolality, DSC, UV-CD, DSF, Microscope FTIR, Rheometer, Flow Cam, Uncle platform.
• Support the development, qualification, and validation of analytical methods specific to the Formulation and Drug product development department.
• Identify technical challenges and effectively troubleshoot any instrument problems and suggest and implement 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

• Education : PhD / Bachelor in relevant Biochemistry / Chemistry specialty.
• Languages : Fluent Spanish and English, knowledge of other languages will be an asset.
• Experience : 3 – 5 years of formulation and analytical experience relevant to the role working with biologics pharmaceuticals and biotech environments.
• Travels : Not required.
• Specific Knowledge : Previous knowledge and hands-on experience with biophysical characterization techniques.
• Personal skills : Ability to work successfully under appropriate supervision using scientific judgment and professional competency. Excellent problem-solving skills as well as time management and organizational skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization. Willingness to work extended and, at times, unusual hours to meet business needs. Teamworking 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.