Associate Director – Analytical Development (AD) – Bioanalytics Late Stage

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Job Description

Objective / Purpose:

As an Associate Director in Analytical Development, it is expected that the individual will independently lead efforts in development of appropriate scientific methods and technology, implementation of evolving scientific technology, drive team objectives and manage team performance in line with Pharmaceutical Sciences’ strategy to deliver on program strategy and initiatives. The individual is expected to have acquired expertise in benchmarking analytical development trends within industry and demonstrate an in-depth working knowledge of Pharmaceutical Sciences and other partner organizational (Research, GMSGQ) roles and program strategy.   

Accountabilities:                                                                                                                                                                                                  

• Expected to independently conduct technical analyses and risk assessments to build knowledge of processes, methods, and to inform related strategies across program and potentially across Pharmaceutical Sciences especially for Bioanalytics for late stage Biologics programs

• Manage staff with accountability for performance and talent development

• Works with senior management to develop and set vision for departmental activities and management of resources.

• Ownership of Bioanalytics late stage area, responsible for establishing and managing operational processes within the department and influencing scientific and process improvement in global AD.

• Strong knowledge of ICH and other regulatory guidelines including Analytical Quality by Design (AQbD)

• Experience in reviewing and approving analytical-related CMC sections of BLA/MAA regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics

• Represents AD and provide guidance to PST teams by leveraging cross program learning, demonstrating ability to understand and communicate impact of technical and project risks on program timelines and other PS functions

• Reviews and interprets complex data, industry trends and incorporates into strategy to communicate clearly to PS functional leadership and partner functional leadership as appropriate.

• Driving vendors and sourcing/consultancy strategy both internally and externally.

• Responsible for developing AD skill set to enable department vision, and management of team performance, engaging with external professional/scientific community, may drive publication strategy

• Complete all required training appropriate to role and function in a timely manner

Education & Competencies:

• Bachelors degree with 15+ yrs relevant experience, Masters degree with 13+ yrs relevant experience, Ph.D. with 7+ yrs relevant experience

• Provides technical/managerial leadership for analytical function, in-depth understanding of PS deliverables and program timelines, driving program strategy, demonstrating leadership in functional and cross functional teams

• Able to communicate to cross functional senior leadership on technology implementation strategy, able to lead or contribute in cross functional teams and ways of working, provide guidance around project leadership and strategy to team members as well as technical guidance  

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