Manager, Technical Operations

Role Overview: Azurity Pharmaceuticals, a specialty pharmaceutical company, is seeking a motivated individual to join their Technical Operations team. As a key player in managing technical process strategy, this role involves overseeing product deliverables in alignment with company objectives. You will lead a team to achieve project milestones supporting process scale-ups, technical transfers, and investigation of deviations for commercial products. Key Responsibilities: - Manage manufacturing planning and execution, including qualification and validation activities for both development and commercial products. - Develop and review controlled documentation for late-stage development, qualification, validation, and commercial manufacturing activities in collaboration with contract facilities. - Support late-stage product/process development, product transfers, equipment qualifications, and validation activities to ensure alignment with company policies. - Lead product launch and commercialization efforts, ensuring compliance with regulatory requirements and industry guidance. - Manage daily commercial manufacturing projects, including technical review and approval of change controls, CAPAs, deviations, and investigations. - Collaborate with cross-functional team members from Supply Chain, Product Development, Quality Assurance, and Regulatory Affairs. Qualifications Required: - Bachelor's degree in Life Sciences (Masters 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. - Experienced in technical transfer of multiple dosage forms and various validation disciplines. - Proficiency in Microsoft Word, Excel, and Powerpoint. - Experience participating in regulatory agency inspections. No additional details of the company were provided in the job description.,