Associate Principal Scientist - Analytical Research and Development

Job Description

Position Description:

Associate Principal Scientist - Analytical Research and Development

An excellent opportunity is available for an Associate Principal Scientist in Analytical R&D with a strong focus on Analytical Tech Transfer program management. The primary objective of this role is to provide technical leadership and oversight for validation and transfer activities for analytical test methods supporting pipeline programs. As an Associate Principal Scientist, you will lead collaboration with cross-functional teams to ensure adherence to current regulatory standards and successful implementation of robust methods at designated testing sites. This pivotal function is essential for driving the effective commercialization of products and ensures a consistent validation approach across all programs.

Our team is dedicated to establishing best-practice validation strategies for our pipeline products, focusing on release and stability analytical methods, and providing comprehensive, standardized guidance to ensure regulatory compliance and robust method implementation at testing sites. This role offers an exciting and dynamic environment with the opportunity to lead and participate in multiple validation and transfer projects across an extensive network of Analytical R&D and Quality Control Laboratories.

Bring energy, knowledge, and innovation to carry out the following:

• Lead and apply project management skills to analytical method validation and transfer activities for pipeline commercialization projects, ensuring testing site readiness

• Implement method validation strategies, and support validation authors with necessary documentation, timelines and project updates

• Collaborate with internal and external labs to support the execution of method validations and transfers by acting as a liaison between key stakeholders through effective communication and applying innovative solutions to issues

• Ensure adherence to timelines by managing approval cycles for validation documentation, sample shipments, site readiness, and method implementation following validation

• Effectively communicate across functions and departments to support management and governance teams in escalating risks, managing issues, and developing mitigation plans

• Stay abreast of industry trends, scientific advancements, and regulatory changes to inform the development and enhancement of analytical method validation and transfer

• Serve as the subject matter expert for reviewing regulatory filings, providing scientific and technical insights and ensuring their compliance with regulatory requirements and industry standards

Position Qualifications:

Education Minimum Requirement:

• B.S. with a minimum of 8 years OR

• Master's with a minimum of 6 years OR

• Ph.D. with a minimum of 3 years of relevant experience in analytical development or quality control

Required Experience and Skills:

• Knowledge in the technical aspects of drug substance and drug product analytical methods used for release, stability, process monitoring and characterization, supported by prior hands-on experience

• Strong understanding of regulatory validation guidelines and prior experience of successfully implementing validation best practices

• Proven track record of managing processes with the ability to effectively track, support and communicate timely delivery of milestones

• Demonstrated ability to work both independently and within cross-functional teams, whether in-person or remotely, fostering collaboration and achieving team objectives

• Strong knowledge and experience in application of current Good Manufacturing Practices (cGMP) to analytical activities within a quality management system

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