Job Description

SummaryThe Dy Manager , Global LTS Microbiology-Policy, Assessment, and Innovation is primarily responsible for supporting new product development/project planning and assessment (microbiology perspective), Global Microbiology Policies and Harmonization, new technology evaluation, QMS, education/training, and provide complex investigation support to QC Microbiology. Support also includes mentorship for method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbiological/biological analyses (including the most complex analyses) using all equipment. This position will have a significant role representing Quality Control in cross-functional teams supporting pending ANDA submissions, product launches, complex product investigations, product development, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. The Dy Manager is responsible for planning, designing, and execution of LTS activities, and leading technical project teams of Scientists and Microbiologists.

• Leads new product development/project planning and assessment (microbiology perspective), Global Microbiology Policies and Harmonization, new technology evaluation, QMS, education/training, and provide complex investigation support to QC Microbiology.
• Leads the process for determining specifications and specification justifications for raw materials and drug products.
• Mentors the development and validation of microbiological/biological methods and the evaluation of compendial changes/updates
• Acts as a liaison between the LTS-Microbiology and Quality Control groups for transfer of knowledge and technology
• Mentors the Method Validation team for Developing and validation experiments designed to provide support for process and formulation activities (e.g. biological challenge, microbiological DS and DP methods)
• Prepares general method validation protocols, harmonized report templates, harmonized microbiological/biological test methods, and microbiological sections for regulatory submissions if required
• Leads new product development/project planning and assessment (microbiology perspective), Global Microbiology Policies and Harmonization, new technology evaluation, QMS, education/training, and provide complex investigation support to QC Microbiology.
• Leads the process for determining specifications and specification justifications for raw materials and drug products.
• Mentors the development and validation of microbiological/biological methods and the evaluation of compendial changes/updates
• Acts as a liaison between the LTS-Microbiology and Quality Control groups for transfer of knowledge and technology
• Mentors the Method Validation team for Developing and validation experiments designed to provide support for process and formulation activities (e.g. biological challenge, microbiological DS and DP methods)
• Prepares general method validation protocols, harmonized report templates, harmonized microbiological/biological test methods, and microbiological sections for regulatory submissions if required.
• Evaluates, troubleshoots/improves existing microbiological/biological methods when necessary
• Independently performs scheduling and coordination of activities of assigned projects
• Oversees project status to ensure that project timelines are met and the team works in compliance with cGMP, GLPs and all other applicable requirements. Presents proposed assessments and harmonized programs to LTS/QC teams for review and discussion
• Writes and reviews SOPs, test methods, general validation protocols and harmonized validation report templates
• Reviews laboratory test data and documentation (e.g. notebooks, raw data and technical documentation, test method, validation protocol, or validation report) for completeness and compliance, when necessary, in support of regulatory filings and commercial product maintenance
• Reviews and evaluates drug substance suppliers technical documents and provides recommendations of API vendor selection
• Is alert to and detects abnormalities during performances of tests and reviews
• Assist in complex laboratory investigations
• Leads root cause identification of complex laboratory investigations
• Evaluates questionable sample results, OOS, and aberrant results and recommends a course of action
• Writes, edits, and reviews SOPs and laboratory investigations
• Identifies need for SOPs and writes or revises, as appropriate
• Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations
• Apprises management of the status of investigations and works with the Compliance group on determination of regulatory actions to be taken
• Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs
• Takes active role in auditing laboratory logbooks/documentation to ensure compliance

Education & ExperienceMasters Degree in above disciplines with 10 years relevant microbiological/biological lab experienceCommitment 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 persons 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.

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