Process Development and Manufacturing Manager - Biologics

About the Role

We are seeking a Process Development and Manufacturing Manager to join our team at SAB BIO. This role is crucial for managing process development and manufacturing projects that support both clinical and commercial manufacturing. As a Process Development and Manufacturing Manager, you will lead the development and characterization of upstream and downstream manufacturing processes, ensuring adherence to quality systems and regulatory compliance.

What You'll Do

• Lead the development and characterization of manufacturing processes, ensuring they meet quality and regulatory standards.
• Define process parameters, select raw materials, and manage manufacturing equipment.
• Participate in equipment and process design for scale-up and tech transfer.
• Collaborate with tech transfer teams to ensure successful scaling of manufacturing processes.
• Oversee department management, including hiring, training, and coaching of staff.
• Ensure compliance with GLP and GMP standards for toxicology and clinical studies.
• Coordinate with other departments to facilitate seamless collaboration on projects.
• Manage materials and vendor approval processes.

Requirements

• Master’s degree with 3+ years of relevant experience or Bachelor’s degree with 5+ years of relevant experience.
• 3 years of experience managing teams in a regulated biologic or pharmaceutical manufacturing environment.
• 5 years of experience with biologic purification techniques such as filtration and chromatography.
• Strong analytical skills and ability to interpret data effectively.
• Excellent communication skills, both written and verbal.
• Proficiency in Microsoft Office and project management software.
• Ability to work independently and manage multiple projects simultaneously.
• Passion for continuous improvement and innovation in manufacturing processes.

Nice to Have

• Certifications related to pharmaceutical development or manufacturing.
• Membership in industry organizations such as PDA or ISPE.
• Experience with AI tools and electronic lab notebooks.

What We Offer

• Competitive salary ranging from $90,000 to $120,000 per year.
• Relocation assistance to help you settle into your new role.
• Comprehensive benefits package including health insurance and retirement plans.
• Opportunities for professional development and continuous learning.
• A collaborative work environment that values innovation and teamwork.
• Commitment to diversity and inclusion in the workplace.