Job Description
**Director, Technical Operations** **Summary:** Manage technical operations, oversee process strategy, and lead cross-functional teams to achieve project milestones in a fast-paced pharmaceutical company. Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products for underserved patients. As an industry leader, Azurity leverages its integrated capabilities and vast partner network to expand its commercial product portfolio and late-stage pipeline. **Key Responsibilities:** * Manage planning and execution of manufacturing, qualification, and validation activities for development and commercial products * Collaborate with contract facilities to review, approve, and execute controlled documentation for late-stage development, qualification, validation, and commercial manufacturing activities * Direct tasks associated with product/process development, product transfers, equipment qualifications, and validation activities to ensure alignment with company policies and objectives * Support product launch and commercialization efforts * Ensure policies, SOPs, and documentation are in place to support validation practices according to regulatory requirements and industry guidance documents * Support Management Review and Compliance activities as needed * Assist in preparing metrics and compiling summaries to communicate status and recommendations to Senior Management * Collaborate closely with cross-functional team members from Supply Chain, Product Development, Quality Assurance, and Regulatory Affairs **Requirements:** * Bachelor's degree in Life Sciences (Master's Degree preferred) * Minimum 15 years of experience in biopharmaceutical/pharmaceutical GMP environment or related industry * Expertise in cGMPs, ICH, and Validation related requirements and guidances * In-depth experience in performing technical transfer of multiple dosage forms * Experienced in multiple validation disciplines, including manufacturing process validation, cleaning validation, packaging validation, analytical methods validation, and facilities validation * Ability to work in a strategic, tactical, and hands-on level * Proficient in Microsoft Word, Excel, and Powerpoint * Experienced in participating in regulatory agency inspections * Strong organizational, interpersonal, and communication skills to plan and accomplish goals * Team-oriented approach to project management and problem resolution * Ability to organize and prioritize project objectives for multiple products/projects * Ability to supervise direct reports and set personal development objectives * Strong analytical and problem-solving skills