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.