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Responsible for New Product Launch (NPL) process activities including creating templates, completing product reviews, customer strategies and launch plans.
Manage the Pricing & Contracts team and work closely with Sales to ensure accurate and timely responses to Requests for Proposal (RFPs), including Terms & Conditions review, Profit & Loss (P&L) preparation / review, RFP price file completion, and RFP submissions.
The Project Manager is responsible for product lifecycle management. Projects will range from early development through commercialization and post-approval changes.
Develop and validate test methods for residual solvents in drug substances/excipients according to ICH/FDA/USP requirements.
The candidate will be expected to independently prepare and review many types of documents for submission to the FDA and customers.
The applicant will be responsible for monitoring the FDA website for labeling changes and ensuring submission labeling meets the required submission standards established by the FDA.
Support the Manufacturing and Packaging teams by ensuring training is conducted in a consistent, effective, and efficient way.
Provides analysis, evaluation and interpretation of varied data including technical assessments of products and manufacturing processes.
The Associate Director of Operational Excellence will lower operational risk, lower operating costs, and increased revenues relative to its competitors, creating value for customers and shareholders.