Director, Analytical Development (Injectable)

Job Description Summary

Lead, manage and direct activities in injectable / complex injectables Analytical Research and Development group to support the R&D programs. Supervision of R&D Analytical lab personnel through the provision of clear objectives, positive employee environment, effective team working and adequate support to ensure their successful and effectively delivery of excellent customer service to all relevant stakeholders.

Job Description

Core Technical Competencies:-

• Ensure on-time support to the product development (PD) teams for development of Sterile injection products. Ensure that the testing of the development batches is completed in time and quality data available to the product development team.
• Ensure that teams develop rugged and robust, validatable analytical methods that are stability indicating for injectable / complex injectable drug products.
• Provide expert input in analysis and characterization of diverse molecular entities including Peptides, Microspheres, Liposomes, carbohydrates, Emulsions and small molecules for Injectable products. 
• Ensure thorough evaluation of DMF holder’s methods and testing of drug substance to qualify the API for development. Ensure that the DMF is reviewed to ensure that it contains data that meets the current FDA expectation for Drug Substance. Where require would interact with the technical team of the DMF holder to resolve issues.
• Coordinate with outside CRO’s / CMO’s for on-time completion of analytical activities. Provide support in review of analytical reports/documents.
• Ensure that all documents required by the regulatory team are available as per agreed timeline for product submission.
• Ensure that all analytical regulatory queries are addressed as per agreed timeline. To ensure that there is no repeat of the query in future submission. To put in place processes that ensure that quality of analytical work ensure minimum queries
• To track the projects to identify the gaps between project status and the set timelines and take corrective and preventive actions to meet the timelines along with HOD and Designee 
• To Co-ordinate with cross functional teams for the timely completion of assigned group activities.
• Ensure that external laboratories used for regulatory work are qualified by internal Quality team. Ensure that required CDA/MSA are in place. Ensure that Analytical team properly coordinates and monitors the work

Quality & safety

• Observance of the laid down standard operating procedure (SOP) as applicable at all PAR formulation sites (Labs, production facilities etc.), including laboratory safety.
• To be updated (self) with latest cGMP/GLP/Regulatory requirements and to train the same to the departmental people.
• Interact with Quality Assurance department during inspections or any audit conducted by regulatory authorizes.

Documentation

• To prepare and review the development reports, study protocols & reports including Stability, Specifications of formulation tentative specification for API, RM and finished product based on scientific rationale with Team Member.

Technology Transfer

• Technical support for any challenges during method validation / transfer of analytical methods.

Education & Experience

• Master of Pharmacy or Master of Chemistry (Full Time) or Ph.D.
• Required Experience: 15-18 yrs. of Analytical research and development experience for regulated market.

Commitment to Diversity, Equity, and Inclusion:  

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.