(ENV137) Formulation & Drug Product Development Technician (Devices)

Mabxience; León; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading company specializing in biosimilar medicines is hiring a Formulation & Drug Product Development Technician for its Manufacturing Site in León, Spain. The role involves executing drug product development activities, conducting analyses, and supporting various drug and device projects. Candidates should have a PhD or Bachelor in Biochemistry or Chemistry and 3-5 years of relevant experience, with a commitment to scientific excellence and teamwork.

Formación

• 3-5 years in drug product, device, and analytical work with biologics in pharmaceutical or biotech environments.
• Fluent in Spanish and English; knowledge of other languages is a plus.
• Hands-on experience with device techniques.

Responsabilidades

• Lead chemical and physical analyses in support of biopharmaceutical product development.
• Conduct laboratory tests and procedures in compliance with GLP, cGMP, and SOP standards.
• Prepare detailed study protocols, SOPs, and technical reports.

Conocimientos

Scientific judgment

Problem-solving

Time management

Effective communication

Teamwork

Educación

PhD or Bachelor in Biochemistry or Chemistry

Descripción del empleo

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. Provide analytical support for drug product and device development. Prioritize group tasks and manage 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 in fill & finish activities.
• Conduct laboratory tests and procedures in accordance with GLP, cGMP, and SOP standards; analyze scientific data accurately.
• Perform analytical tasks with minimal supervision related to drug product and device development.
• Perform tests on candidates for biological drugs using techniques like CCIT, FlowCAM, Stoppering & Assembly machine, Microscope FTIR, Rheometer, UTT machine (for medical devices).
• Support the development, qualification, and validation of analytical methods specific to formulation and drug product development.
• Identify technical challenges, troubleshoot instrument problems, and suggest improvements.
• Prepare detailed study protocols, SOPs, and technical reports timely and efficiently.
• Maintain laboratory organization and equipment; train staff on procedures when required.

Requirements and Personal Skills:

• Education: PhD or Bachelor in Biochemistry or Chemistry.
• Languages: Fluent in Spanish and English; knowledge of other languages is an asset.
• Experience: 3-5 years in drug product, device, and analytical work with biologics in pharmaceutical or biotech environments.
• Knowledge: Hands-on experience with device techniques.
• Personal Skills: Scientific judgment, problem-solving, time management, effective communication, teamwork, and willingness to work extended hours if needed.

mAbxience is committed to equal opportunities, considering all candidates without discrimination based on race, color, gender, age, sexual orientation, religion, origin, marital status, citizenship, or disability.