Qualifications

• Bachelor's Degree in Sciences or Engineering or equivalent experience.
• 5 years of experience in biotech or pharmaceutical manufacturing operations.
• 5 years of project management experience in a biotech, pharmaceutical, or CMO setting.
• Experience with aseptic operations and drug product manufacturing preferred.
• Strong grasp of GMP regulations and compliance in manufacturing facilities.
• Proficient in analyzing and improving manufacturing process data.
• Excellent written and verbal communication skills, especially in technical writing.
• Ability to work collaboratively in cross-functional teams and manage multiple projects effectively.
• Self-motivated and comfortable in a fast-paced environment.

Responsibilities

• Lead proposal writing and review efforts for new product introduction.
• Conduct facility fit assessments, including risk and process impact analyses.
• Oversee technology transfer from development to manufacturing.
• Translate process development reports into manufacturing batch records and SOPs.
• Provide hands-on training for manufacturing processes during technology transfer.
• Develop and manage process improvement projects.
• Implement systems for enhanced GMP planning and execution.
• Oversee clinical and commercial program lifecycle management.
• Manage project plans and key deliverables for stakeholders.
• Act as primary liaison for clients, ensuring quality in contract manufacturing services.
• Serve as a technical interface between internal teams and clients.
• Support root cause investigations and implementation of corrective actions.
• Author and manage change control for projects.
• Drive operational excellence through process improvement.

Benefits

• Opportunity to drive meaningful projects in a dynamic biotech environment.
• Collaborative work culture with cross-functional teams.
• Exposure to various aspects of product development and manufacturing.
• Hands-on experience in technology transfer processes.
• Potential for career advancement within the organization.