Formulation & drug product development technician (devices)

mAbxience; Madrid; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A biopharmaceutical company in Madrid is seeking a candidate to lead drug product and device development activities. The role requires a Ph.D. or Bachelor's in Biochemistry or Chemistry, along with 3-5 years of relevant experience. The successful candidate will manage analytical tasks and laboratory procedures while supporting product development. Fluency in Spanish and English is mandatory, and teamwork is essential. The position does not require travel.

Formación

• 3-5 years of experience in drug product and device development.
• Fluent in Spanish and English; knowledge of other languages is a plus.
• Previous experience in biological pharmaceuticals and biotech environments.

Responsabilidades

• Lead drug product and device development activities.
• Conduct laboratory tests following GLP, cGMP, and SOP standards.
• Prepare detailed study protocols, SOPs, and technical reports.
• Train staff on laboratory procedures.

Conocimientos

Analytical test execution

Laboratory procedures

Scientific communication

Problem-solving

Teamwork

Educación

PhD / Bachelor in Biochemistry / Chemistry

Descripción del empleo

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.

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.