Senior Scientist Analytical Development of Biologicals
Your Tasks And Responsibilities:
Develops and aligns a global strategy for test method development and validation, stability studies, analytical control strategy, etc. within ARD and cross-functionally considering the global regulations and GMP requirements with focus on new biological entities (NBE) and chemical entities (NCE);
Manages effectively local/global interfaces (LU, US East and West Coasts and Lake County) and drives cross-functional alignment (DPD, Regulatory, QA, S&T, etc.). Contributes to global cross-functional initiatives to improve processes and facilitates their implementation;
Evaluates the regulatory landscape for new requirements and changes impacting the area of responsibility and ensures their implementation.
Who you are:
Degree in pharmaceutical sciences, chemistry, biochemistry, molecular biology, food sciences or related field, preferably with PhD;
Minimum 5 years of experience in the pharmaceutical industry with exposure to analytical development across all stages of development, including regulatory filings;
Sound expertise in development of complex analytical methods and practical experience with test method validation preferably for NBEs;
Experience with analytical areas relevant for the filing strategy of development programs (e.g. stability testing, analytical control strategy,);
Sound knowledge of global GMP requirements and regulations and experience with their implementation in a global ARD development strategy.
Innovation & Scientific Leadership:
Is up to date on regulatory expectations (guidelines, GxPs as appropriate) and translates these in locally and globally aligned strategy and executable approaches;
Drives/coordinates local and global initiatives to align and improve processes;
Adapts to changing environments and balances priorities within function;
Supports the utilization of appropriately risk based approaches to ensure project and internal/external budget success and to increase efficiency;
Drives technological innovation and guides improvements to leverage operational excellence within function and in line with the ARD vision;
Serves as SME and consultant for ARD project teams;
Contributes to creating and establishing a new centralized function within AR&D.
Builds strong relationships with peers to create and implement aligned local and global processes and strategies as it relates to area of responsibility;
Motivates and influences others to drive global alignment and process improvement;
Knows the business to influence long-range strategy;
Deals comfortable with uncertainty, ambiguity and risk to make decisions having mid-term impact. Ensures alignment with corporate/regulatory policies/standards;
Learns fast, grasps the essence and can change course quickly where indicated to manage and prioritize resources & timelines across a wide range of development programs/scientific initiatives within area of responsibility.