Senior Researcher in Monoclonal Antibodies

Place of work

Anagni (FR)

Job description

We are seeking a seasoned and highly knowledgeable Senior Researcher in Monoclonal Antibodies to play a pivotal role in advancing our R&D capabilities. This role will focus on training and mentoring the existing R&D team for the implementation of industrial-scale production. The ideal candidate will have extensive experience in both monoclonal antibody research and the processes required for successful scale-up to manufacturing.

Key Responsibilities:

Training and Mentorship:

• Develop and implement comprehensive training programs for the R&D team focused on monoclonal antibody research and development.
• Provide hands-on training and mentorship to junior researchers and scientists, ensuring they gain the necessary skills and knowledge to contribute effectively to monoclonal antibody projects.

Research Leadership:

• Lead advanced research projects oncharacterization, and optimization of monoclonal antibodies with a focus on scalability and manufacturability.
• Guide the R&D team in adopting best practices and methodologies that align with industrial-scale production requirements.

Process Development for Scale-Up:

• Collaborate closely with the production and process development teams to ensure smooth technology transfer from the research lab to the manufacturing floor.
• Develop and refine protocols for the scale-up of monoclonal antibody production, considering factors such as yield optimization, cost efficiency, and regulatory compliance.

Collaboration:

• Work in close collaboration with cross-functional teams including process development, manufacturing, and quality assurance to ensure that research outputs are fully aligned with production needs.
• Foster a collaborative environment that encourages knowledge sharing and continuous improvement across teams.

Regulatory and Quality Compliance:

• Ensure that all R&D activities comply with relevant regulatory standards, including Good Laboratory Practices (GLP) and guidelines relevant to monoclonal antibody production.
• Prepare and review documentation related to the research and development processes, including standard operating procedures (SOPs) and technology transfer documents.

Innovation and Continuous Improvement:

• Stay up-to-date with the latest advancements in monoclonal antibody research and industrial-scale production technologies.
• Identify and implement innovative approaches to improve the efficiency and effectiveness of monoclonal antibody development and scale-up processes.

Qualifications:

Education:

• PhD in Immunology, Biochemistry, Molecular Biology, or a related field with a focus on monoclonal antibodies.

Experience:

• Minimum of 7-10 years of experience in monoclonal antibody research, with significant experience in industrial-scale production or process development.
• Proven track record of leading and mentoring research teams, with experience in training and development.

Technical Expertise:

• Deep understanding of monoclonal antibody discovery, characterization, and optimization techniques.
• Extensive experience with processes involved in scaling up monoclonal antibody production, including upstream and downstream processing.

Leadership and Communication:

• Strong leadership and team-building skills, with the ability to inspire and develop a team of researchers.
• Excellent communication skills, both verbal and written, with the ability to convey complex technical concepts to a non-technical audience.

Project Management:

• Strong project management skills, with the ability to manage multiple projects and meet deadlines in a fast-paced environment.

Preferred Qualifications:

• Experience in technology transfer and the development of monoclonal antibodies for clinical or commercial use.
• Familiarity with regulatory requirements for biopharmaceutical production, including FDA, EMA, or other relevant bodies.

Knowledge of process analytical technologies (PAT) and Quality by Design (QbD) principles