Senior Director - Manufacturing, Science and Technology
21 hours ago
Description
• Provides technical and operational support for manufacturing activities for drug product. • Oversees early access and commercial label generation and release. • Ensures adherence to relevant regulatory requirements and company SOPs. • Collaborates with internal and external teams to troubleshoot manufacturing processes.
Requirements
• Bachelor’s degree in a scientific or engineering discipline. • Minimum of 9 years of relevant experience in small molecule drug product formulation and manufacturing. • Minimum of 5 years in technology transfer and process validation related activities. • Excellent knowledge of GMP, GCP, and ICH guidelines. • Demonstrated experience with process validation and regulatory requirements. • Experience overseeing/managing CDMOs conducting clinical and commercial manufacturing. • Ability to influence without direct authority. • Excellent verbal and written communication skills. • Analytical thinker with excellent problem-solving skills.
Benefits
• Eligible for short- and long-term incentives. • Enroll in medical, dental, vision, and retirement savings plans.
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