Senior Director of Analytical Development
3 weeks ago
At BioSpace, Inc., we are seeking a highly skilled and experienced Associate Director to lead our Analytical Development team in the Bioanalytics Late Stage area. The successful candidate will be responsible for independently conducting technical analyses and risk assessments to build knowledge of processes, methods, and to inform related strategies across program and potentially across Pharmaceutical Sciences.
Key Responsibilities:
- Manage staff with accountability for performance and talent development
- Work 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
- Represent 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
Requirements:
- 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
About Us:
BioSpace, Inc. is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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