Copenhagen

Position Summary: The Drug Substance Process Specialist will be responsible for developing, optimizing, and overseeing the manufacturing processes for biologic drug substances, with a focus on Live Biotherapeutic Products (LBPs). This role involves collaboration with Research, Quality, and Regulatory teams to ensure efficient and compliant production of high-quality biologic drug substances at partner CDMOs.

Key Responsibilities:

Process Development and Optimization:

• Develop and optimize scalable manufacturing processes for biologic drug substances, specifically LBPs.
• Conduct experiments to enhance process efficiency, yield, and robustness.
• Implement process improvements based on data analysis and scientific principles.

Manufacturing Support:

• Provide technical support to manufacturing operations, troubleshooting issues related to process performance and product quality.
• Collaborate with cross-functional teams for seamless technology transfers.
• Monitor production processes for compliance with established protocols and regulatory requirements.

Quality and Compliance:

• Ensure adherence to Good Manufacturing Practices (GMP) and other regulatory standards.
• Participate in internal and external audits, providing technical expertise and documentation.

Collaboration and Communication:

• Work closely with Research, Quality Assurance, and Regulatory Affairs teams to align on project goals and deliverables.
• Communicate effectively with stakeholders to provide updates on process development, scale-up activities, and manufacturing performance.
• Prepare and present technical reports, summaries, and presentations.

Continuous Improvement:

• Stay current with advancements in bioprocessing technologies and industry trends.
• Identify opportunities for innovation and improvement in the manufacturing process.
• Participate in professional development activities and training programs.

Qualifications:

Education:

• Bachelor’s or Master’s degree in Biochemical Engineering, Biotechnology, Microbiology, or a related field. Ph.D. preferred.

Experience:

• Minimum of 8 years of experience in biologics manufacturing or process development, with a LBPs or live microbial products as an advantage.
• Proven track record of developing and optimizing bioprocesses for scale-up and commercial production.

Technical Skills:

• Strong understanding of bioprocessing principles, including fermentation, cell culture, purification, and formulation.
• Proficiency in using bioprocessing equipment and analytical instruments.
• Experience with process simulation and modeling software is a plus.

Soft Skills:

• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills.
• Ability to work effectively in a team-oriented, collaborative environment.

Regulatory Knowledge:

• Familiarity with GMP, FDA, EMA, and other relevant regulatory guidelines.

Experience with regulatory submissions and inspections is highly desirable.

Contact
If you want to hear more about this opportunity and the company, or if you have any questions regarding the position, please do not hesitate to contact us. If you wish to apply for the position, please send an updated version of your CV, together with what questions you might have, and we will get in touch with you soon.

DANIEL OLSEN
Senior Consultant
BUSINESS DEVELOPMENT
[email protected]