Senior Drug Product Development Manufacturing Lead

Job Summary

A company is looking for a Senior Drug Product Development & Manufacturing Lead.

Key Responsibilities:

• Develop and execute strategic plans for drug product development, manufacturing, supply, and global submissions
• Oversee drug product manufacturing processes and ensure efficient commercial operations
• Implement process improvements and advanced manufacturing technologies to enhance productivity and quality

Qualifications:

• In-depth knowledge of solid dosage unit processes
• Experience in batch record reviews and investigations related to manufacturing deviations
• Ability to collaborate with cross-functional teams and drive alignment
• Expertise in process validation activities and statistical process control techniques
• Experience in authoring/reviewing regulatory submissions related to drug product development and manufacturing