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
* Education : PhD / Bachelor in relevant Biochemistry / Chemistry specialty.
* Languages : Fluent Spanish and English, knowledge of other languages will be an asset.
* Experience (years / area) : 3 – 5 years of drug product, device 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 device 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.
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.
Product Development • Castilla and Leon, Spain
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