Manager, Technical Operations

As a member of the Technical Operations team at Azurity Pharmaceuticals, you will play a crucial role in managing and overseeing technical process strategy, CMO and CDMO management, and the execution of product deliverables. Your dedication and expertise will contribute to the success of Azurity in providing innovative products to underserved patients. Here are the key responsibilities and qualifications required for this role: **Key Responsibilities:** - Manage the planning and execution of manufacturing for both development and commercial products, including qualification and validation activities. - Develop, review, and approve controlled documentation related to late-stage development, qualification, validation, and commercial manufacturing activities. - Support late-stage product/process development, product transfers, equipment qualifications, and validation activities to ensure alignment with company objectives. - Lead product launch and commercialization efforts. - Ensure validation practices are in accordance with regulatory requirements and industry guidance documents. - Collaborate with cross-functional team members from Supply Chain, Product Development, Quality Assurance, and Regulatory Affairs. - Daily management of commercial manufacturing projects including technical review and approval of change controls, CAPAs, deviations, and investigations. **Qualifications and Education Requirements:** - Bachelor's degree in Life Sciences (Master's Degree preferred) or related field. - Minimum of 8 years of experience in biopharmaceutical/pharmaceutical GMP environment or related industry. - Thorough knowledge of cGMPs, ICH, and Validation related requirements and guidances. - Experience in technical transfer of multiple dosage forms and various validation disciplines. - Proficiency in Microsoft Word, Excel, and Powerpoint. - Experienced in participating in regulatory agency inspections. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities without any restrictions. If you have any concerns or disabilities that may affect your ability to perform the job, please inform HR in advance. Join Azurity Pharmaceuticals, an inclusive workplace and Equal Opportunity Employer, where your dedication and expertise will make a difference in the lives of patients. Visit www.azurity.com for more information.,