Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
The Director, Technical Operations is responsible for management and oversight of Technical Operations process strategy, CMO and CDMO management, and execution of product deliverables in alignment with Azurity policies, Azurity clients and in accordance with company objectives. The position leads staff and / or contractors and collaborates cross-functionally to achieve project milestones. The Director must possess a strong technical knowledge of drug product development, technology transfer, process validation, and commercial manufacturing, preferably demonstrated with previous drug development and commercialization experience. This position reports to the Vice President, Technical Operations.
Requirements
* Manage the planning and execution of manufacturing along with associated qualification and validation activities as they relate to both development and commercial products.
* In cooperation with contract facilities, manage the review, approval, and execution of controlled documentation concerning late-stage development, qualification, validation, and commercial manufacturing activities as needed.
* Direct tasks associated with product / process development (as applicable), product transfers, equipment qualifications, and validation activities to ensure alignment with company policies and objectives.
* Support and / or lead product launch and commercialization efforts.
* Ensure that appropriate policies, SOPs and documentation are in place to support validation practices according to regulatory requirements and applicable industry guidance documents.
* Support Management Review and Compliance related activities as needed. Assist in preparing metrics and compiling summaries to effectively communicate status and recommendations to Senior Management.
* Support Due Diligence activities to support company objectives including product development, technical transfer, commercial manufacturing, and/or commercial launch.
* Collaborate closely with cross-functional team members from functions including Supply Chain, Product Development, Quality Assurance, and Regulatory Affairs.
* Assist and advise other departments as required. Provide recommendations and input regarding departmental policies, procedures, goals and objectives; make judgments and decisions in a sound logical manner.
* Possibility of up to 40% travel, both domestic and international
Experience Required
* Hard Skills
* Bachelor's degree in Life Sciences (Master's Degree preferred), or related field.
* 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 (solid oral, liquid oral, injectables, etc.)
* Experienced in multiple validation disciplines including manufacturing process validation of multiple dosage forms, cleaning validation, packaging validation, analytical methods validation, terminal sterilization validation, hold time studies, shipping studies, equipment / utilities qualification, and facilities validation
* Ability to work in a strategic, tactical, and hands-on level.
* Candidate must be proficient in Microsoft Word, Excel, and Powerpoint.
* Experienced in participating in regulatory agency inspections.
* Soft Skills
* 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 setting of personal development objectives.
* Interact with all levels of the organization and with current partners (and potential partners)
* Strong analytical and problem-solving skills
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