Associate Director, Technical Operations

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:

• Draft / Review / Approve analytical method transfers, validations, verifications documentation to ensure correct implementation of validation strategy.
• Provide on-site CMO oversight during execution of analytical method transfers, validations, verifications activities to ensure alignment with approved strategy and documentation in support of Tech Transfers, product validations and product lifecycle changes.
• Serve as the Tech Ops analytical Lead and coordinate with the Azurity cross-functional and CMO teams during preparation for and execution of analytical method transfers, validations, verifications needed for post-registration scale-up and engineering batch manufacturing and, and process qualifications batches.
• Prepare / support CDMO RFQ/RFP as needed to support opportunities for technology transfer, scale-ups, validation, and post approval changes. Review and approval of proposals for post registration CDMO activities with reference to the analytical activities.
• Coordinate with CMOs for CMC documents needed in support of regulatory filings. Timely review of m3 sections for accuracy prior to filing
• Review due diligence documentation and provide feedback on red flags and value erosion findings to Business Development team in support of opportunities. Timely communications through due diligence trackers, summary of findings, etc.
• Review and approve (as applicable) post approval product deviations / OOS / complaint investigations. Support root cause analysis and determination of CAPAs in support of issue resolution.
• Review, provide technical assessment and support the implementation of post approval changes and support documentation at CMOs.
• Oversee all analytical activities required for supporting product development at Development lab and/or Contract Research Organization (CRO), CTL and/or CMO/CDMO.
• Provide guidance for analytical method development and method verification to analytical scientists.
• Review of analytical raw data ensuring maintenance of data quality throughout product development and lifecycle.
• Review of standard operating procedures pertaining to analytical activities at CMO/CRO network.
• Review of specification, Analytical Test methods, method verification/validation protocol, and reports CTL, and/or CMO/CDMO.
• Review of Drug Master File (DMF) provided by Active pharmaceutical ingredient (API) vendor and
  co-ordinate with them to address any deficiency specific to analytical if applicable.
• Evaluation of impurities from various sources, finalizing the source.
• Draft and/or Review of various CMC study protocols and reports, e.g., ICH stability study, photo-stability study, hold time study, in-use study.
• Preparation and review of the Risk assessment report and justification reports like chiral purity chiral purity, residual solvent justification, elemental impurities risk assessment, Nitrosamine risk assessment, etc.
• Troubleshooting of technical areas pertaining to analytical activities at CRO, CTL, and/or CMO/CDMO, and if required, visiting these sites for the same.
• Review of Quality management system (QMS) documents such as change controls, deviations, out of specifications for CRO, CTL, and/or CMO/CDMO.
• Responsible for addressing all analytical queries/deficiencies arising from regulatory authorities specific to assigned products.
• Responsible for monitoring of overall periodic Pharmacopeial updates of assigned products for API, excipients and drug products.
• Assessment of CRO, CTL, and/or CMO/CDMO suitability for Analytical capability.
• Audit the contract research organization, contract testing laboratory and contract manufacturing organization, active pharmaceutical site to Azurity projects and preparation of audit reports

Qualifications and Education Requirements

• 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 working directly with analytical instrumentation and methodologies. 
• Expertise in 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.