Research Scientist, Science

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

Descripción de la vacante

A leading biopharmaceutical company in Madrid is seeking an experienced Bioassay Scientist to coordinate the Bioassay group and develop analytical methods. The ideal candidate will have a Master's or PhD in Biological Sciences, along with extensive experience in bioanalytical assay development and effective communication skills in English and Spanish. This role offers competitive compensation and an inclusive work environment.

Formación

• Master’s degree or PhD with major in Biological Sciences or related.
• 5-7 years of experience in bioanalytical assay development.
• Hands-on experience with bioanalytical tools.

Responsabilidades

• Co-ordinate and supervise the Bioassay group.
• Develop, implement, and qualify high-complexity assays.
• Document analytical activities accurately in a timely manner.

Conocimientos

Analytical skills

Communication skills in English

Interpersonal skills

Problem-solving skills

Method troubleshooting

Educación

Master’s degree or PhD in Biological Sciences

Herramientas

SPR

ELISA

Flow Cytometry

Western blot

Enzymatic assays

Cell-based assays

Descripción del empleo

At mAbxience, a company specialized in the development and manufacturing of biosimilar medicines, we are hiring a Bioassay Scientist for our Manufacturing Site in León (Spain).

GLOBAL RESPONSIBILITY

This individual will be responsible to co‑coordinate the work of the Bioassay group inside analytical development. The main task will be development, qualification and validation of new bioanalytical methods, co‑ordination of sample testing to support process and formulation development and other developmental activities of biotherapeutic drug candidates at all stages of development. Review of external development and qualification & validation reports. Bioanalytical techniques include but are not limited to high complexity cell‑based test assays (ADCC, CDC, neutralization, apoptosis, etc.), SPR, target binding ELISA, flow cytometry‑based binding assays, and residual impurities analysis in compliance with GLP / GMP and regulatory guidance as it relates to drug substance and drug product development. This individual will be required to present and interpret scientific data, write technical reports, and represent the team in matrix or R&D group meetings when needed.

SPECIFIC RESPONSIBILITIES

Performs the assigned analytical tasks individually if needed in support of product development, registration lot release, pre‑ and post‑regulatory submission activities. Performs activities within the assigned timelines and in compliance with GLP / GMP, regulatory requirements and company practices and procedures.

• Co‑ordinate and supervise the work of the Bioassay group (technicians and analysts).
• Develop, implement, and qualify high‑complexity Surface Plasmon Resonance (SPR) and cell‑based test assays (ADCC, CDC, neutralization, apoptosis, etc.) as well as process impurities in compliance with GLP / GMP and regulatory guidance to support process and formulation development.
• Identify technical challenges during analytical method development and perform method troubleshooting.
• Proactively participate in activities in support of process development and process changes.
• Design, follow, and review protocols, scientific methods, and departmental procedures; organize and interpret scientific data.
• Document analytical activities and results accurately, in a timely manner and right‑first‑time.
• Review and check analytical data generated by peers and maintain data integrity.
• Communicate effectively with peers, supervisor, and management about the status of the assigned activities, maintaining supervisor constantly updated.
• Write and review technical and data‑analysis reports, SOPs, tech transfer documents and maintain accurate, precise, legible documentation.
• Support quality control during tech transfer and validation.

REQUIREMENTS AND PERSONAL SKILLS

• Education: Master’s degree or PhD with major in Biological Sciences or another science‑related major.
• Languages: Excellent communication and interpersonal skills in English and Spanish, both written and verbal are required. (Spanish is not a must).
• Experience: PhD with 5‑year industry experience or MS with minimum 8‑10 years of relevant experience in biopharmaceutical / biotechnology industry. Graduation gained from chemistry, analytical chemistry, biology, biochemistry, immunology, bioengineering, pharmacology, or other related disciplines preferred.
• Experience: Minimum 5‑7 years’ experience with development, validation of bioanalytical assay methods in a regulated Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP) environment.
• Experience: Hands‑on experience and proficiency with the use of various bioanalytical and biochemical tools including but not limited to SPR, ELISA, Western blot, enzymatic assays, cell‑based assays.
• Experience: Hands‑on experience with Flow Cytometry.
• Knowledge: Knowledge of Surface Plasmon Resonance (SPR) platform.
• Knowledge: Knowledge of biologics and industry experience in biologics research / development.

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.