Manages staff with accountability for performance and results of team, and has authority to commit area resources to CMC/project teams. Contributes to and drives line function strategy. Uses technical expertise to contribute across multiple projects. Benchmarks current industry trends in functional area. Establishes and manages operational processes within the department/function. Contributes to wider cross-functional/cross divisional strategy and drives initiatives to completion. Leads or provides strategic guidance across projects that involve extraordinary, well-considered risks. Directs and manages outsourcing across a product platform as appropriate.
- Develops and manages strategies for departmental infrastructure, resources, projects, etc. in conjunction with senior staff.
- Recommends and implements new technologies and innovations as appropriate.
- Contributes significantly to develop, drive and set vision and direction of departmental activities, management of resources, time, personnel and financial resources.
- Manages aspects of department performance, personnel issues, and effective communication within group and with the company as directed by senior staff.
- Communicates and coordinates implementation of procedural improvement to senior management, across therapeutic and scientific areas.
- Conducts analysis of technical and conceptual risk; identifies and champions operational processes and strategies.
- Serves as a technical resource to guide group members in strategic decision making (and technical guidance as appropriate)
- Incorporates industry trends and company goals in departmental strategy.
- Maintains complete technical responsibility for a program(s)/initiative(s) within the department.
- Leads GCT sub teams and/or other cross functional teams
- Leverages knowledge of multiple projects and functional areas to guide team members on potential impacts in both strategic and technical aspects.
- Insures effective project management of all plans and projects within own area of responsibility and direct reports, linking all scientific efforts to company, program and functional goals.
- Contributes to cross-departmental strategy.
- Develops discipline/departmental plans and drives strategy and implementation for respective group, creating linkages with strategies of other relevant functions.
- Identifies topics for initiatives and leads local/global department initiatives
- Provides technical /departmental leadership by fostering development of skill sets among staff, and providing guidance on project leadership and cross-functional awareness
- Initiates or endorses complex projects with extraordinary technical challenges and applies broad technical risk assessment skills.
- Identifies potential changes within department in infrastructure, processes and scientific rationale and leads aspects of the change planning as appropriate.
- Proposes cross-functional improvements
- Defines outsourcing strategy for department in conjunction with senior staff.
Communicates with senior management of other functions on implementation of infrastructure, technology, work processes, or business processes.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education and Experience:
- Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 15+ years relevant industry experience
- Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 13+ years relevant industry experience
- PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 7+ years relevant industry experience
- Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP s
- Sound knowledge of current Good Manufacturing Practices (cGMP)
- Significant relevant pharmaceutical development experience
- Significant technical and strategic leadership experience with direct accountability for managing a team of direct reports.
- Experience in working in a multi-disciplinary environment with accountability for informing departmental or functional strategy.
- Experience leading functional regulatory strategy
Knowledge and Skills:
Experience leading a cross-functional team in the development of a pre-filled syringe combination products, Experience authoring Design Controls and Quality Risk Management documents; Experience discussing combination products/devices with regulatory agencies; Experience planning and executing Human Factors studies. Experience developing Biologics products.
May require approximately 15-20% travel.
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