Associate Director-Analytical Method Validation & Transfer

POSITION SUMMARY

The Associate Director AMV is the analytical method validation lead & works with the Head Analytical Research (Formulations)/Head Global Analytical Validations based in India. The AMV lead at Monroe will liaison with injection development teams in India and oversee successful method validation at Monroe site. The Associate Director is responsible to provide analytical support for ANDA filings and regulatory deficiency response. The position also supports analytical method validation lifecycle management.

Project Coordinator Duties and Responsibilities:

• Lead and manage the team carrying out the analytical validation for all methods of API, Excipients and Finished products.
• Approve validation protocols, reports, SOPs related to validation and method change justifications.
• Lead and manage invitro studies at site as per requirements.
• Lead and manage the analytical method technology transfer of API, Excipients and Finished products to QC (Both in house and from third party CTLs).
• Coordinate and collaborate with QC during Exhibit batch analysis and stability analysis.
• Collaborate with Analytical R&D, QA, Manufacturing, Tech Transfer, and Regulatory Affairs.
• Provide technical guidance during investigations, OOS/OOT, and CAPA implementation.
• Submission of analytical documents to Regulatory affairs for filing purpose.
• Respond to regulatory queries, FDA deficiencies, and observations related to analytical methods.
• Lead and manage the life cycle management for analytical methods for API and Finished Products.
• Coordinate with CMOs for analytical work and help them to do troubleshooting.
• Act as a subject matter expert (SME) for analytical validation during regulatory inspections and audits.
• Expected to support Pillar, Argentina and Osasco Brazil for analytical validation related activities

JOB RESPONSIBILITIES

Responsibilities

Manage the AMV team at Monroe to achieve the ANDA filings as per the project GRID

Collaborate with RA and Global PM teams to plan and execute experiments, provide justification/write-up for regulatory queries related to ANDA filing

Collaborate with CMO/CTL for successful execution analytical activities in support of ANDAs

Collaborate with quality team at Monroe for successful execution of ANDAs

Any other activities as assigned

KNOWLEDGE, SKILLS AND ABILITIES

Education

Minimum MS/Ph D in Pharmaceutical Sciences, Analytical Chemistry, or equivalent

Experience

18 + years in the Pharmaceutical Industry

Knowledge and Skills (Functional / Technical)

• Chromatography
• Wet chemistry
• Injectable products in general
• In Vitro studies
• US FDA guidance related to analytical development, validation, specifications and
• Knowledge of instrumentation like HPLC, GC, Malvern PSD, Zetasizer, UHPLC etc.
• Sameness Studies

Leadership / Managerial Attributes

• Able to manage a team of 4-6 direct reports
• Able to deal with multiple locations