Manager, Technical Operations

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.

Brief team/department description:

Technical Operations is responsible for management and oversight of technical process strategy, CDMO management, and execution of product deliverables in alignment with Azurity policies and objectives. The position leads staff and contractors and collaborates cross-functionally to achieve project milestones in support of process analytical method developments, analytical method validations, analytical method verifications and validations, method verification of excipients, packaging materials, scale-ups and process validation, technical transfers, implementation of lifecycle post approval changes, and investigation / closure of deviations / OOS for commercial products. This position ensures the post registration development activities, tech transfers, validation / launch and product post approval change projects are driven to success across CDMO network. This role is responsible for complete cycle project deliverables specific to Analytical activities to the product transfers, scale-up to manufacturing sites, and commercial manufacturing of drug products.

Principle Responsibilities:

• Develop analytical methods for product development. 
• Conduct forced degradation studies and identify unknown impurities.
• Perform experiments to address regulatory queries.
• Qualify and maintain working and reference standards per storage requirements.
• Verify analytical methods. Execute analytical ATR, document results, and share findings with the formulation team.
• Conduct literature reviews and follow good documentation practices.
• Prepare and execute protocols and technical reports.
• Prepare method development and verification reports and test methods.
• Support method validation, transfer, and verification as applicable.
•  Review API and excipient methods from vendors and monographs.
• Apply pharmacopeial information to product development where applicable.
• Comply with data integrity requirements and regulatory expectations.
• Support CRO and CMO analyses as needed to address queries
•  Initiate change controls and deviations in the Analytical department as needed.
• Investigate deviations.
• Calibrate HPLC systems, dissolution apparatus, KF apparatus, and pH meters.
• Prepare specifications and STPs.
• Prepare CoAs. Archive documents, records, and lab notebooks.
• Maintain GLP, lab cleanliness, and safety standards.
• Ensure all documents and data are adequate, accurate, and complete.
• Organize, attend, and provide required training.
• Procure project materials such as columns, reagents, standards, and impurities.
•  Track chemicals, solvents, standards, impurities, and other project needs.
•  Handle RGP and NRGP where applicable.
• Dispose of leftover samples, expired chemicals, and reagents as applicable.
• Send and receive samples or materials to and from CROs, CTOs, and CMOs as applicable.

Qualifications and Education Requirements

• Bachelor’s degree in Life Sciences (Master’s Degree preferred), or related field.
• Minimum 8 years of experience in biopharmaceutical/pharmaceutical GMP environment or related industry working directly with analytical instrumentation and methodologies.
• Thorough knowledge of cGMPs, ICH, USP and Validation related requirements and guidances
• In-depth experience in performing analytical / microbial method transfers, validations, verifications, etc., supporting multiple dosage forms (solid oral, liquid oral, injectables, etc.)
• Basic understanding of multiple validation disciplines including manufacturing process validation of multiple dosage forms, cleaning validation, packaging validation, terminal sterilization validation, hold time studies, shipping studies, equipment / utilities qualification, and facilities validation, with in-depth expertise in analytical methods 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.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.