Description:

Impact on business results

• Lead analytical method development and validation activities to support formulation and manufacturing process development activities.
• Manage Global and China stability programs for the project. This would include writing and/or approving stability protocols, interpretation of data and subsequent regulatory specification setting.
• Ensure suitability of all analytical method development work and method validation status to meet the regulatory requirements of Global and China CMC submission.
• Author Drug Product sections for CMC dossier submissions, suitable for Global and China submission.
• Lead method establishment at AstraZeneca Clinical or Commercial Operations facilities.
• The role holder will have sufficient experience to lead these activities independently.
• To provide scientific or technical supervision to junior members of the team within AstraZeneca and within CROs to enable them to optimally meet their project objectives.
• To provide disciplinary scientific leadership and present work through patents, publications and lectures.
• Maintain good knowledge of the external regulatory environment.
• Contribute to constructive scientific debate during project technical reviews across the portfolio.

Accountabilities/Responsibilities:

People Management, Problem Solving, Communication

The role holder will:

• Provide expert technical guidance, challenge and problem solving in projects.
• Take responsibility for the quality, communication and delivery of science in projects.
• Will act as project coordinator and be a member in the core project teams supporting Global development activities.
• Provide disciplinary scientific leadership, coaching and mentorship for junior scientists both internally and with external suppliers.
• Identify improvements in science and technologies that can be successfully applied to advance department activities that contribute to achievement of Business goals.
• Recommend, gain commitment to, initiate, lead and champion new science and technology initiatives within the department that improve its capability to deliver on projects.
• Be an active member of scientific discipline networks.
• Demonstrate creativity and innovation on projects.

Minimum Requirements – Education and Experience

Functional & Business knowledge

Experience, Functional Knowledge, Business Knowledge, Education, Specialist Skills

• Demonstrated a proven track record of delivery and experience in product development.
• Have a good understanding of the overall drug development process with an appreciation of how CMC development contributes to R&D.
• Will have lead authoring and submission of CMC dossiers and answered subsequent Regulatory Questions.
• Significant experience in pharmaceutical science, including demonstrating scientific leadership.
• Have experience of technical supervision, coaching and mentoring or leading small teams of people or scientific projects.
• Evidence of good communication skills and of building good relationships with customers.
• Evidence of expertise on in-vitro performance testing and stability studies.
• Experience in method development for degradation product.
• Evidence of scientific report writing skill.

Internal and External Contacts/Customers

• This role will have key contacts and customers at external service providers as well as internally within their function, department and project teams and will act as an opinion leader in the scientific community in the department.
• This role will have significant interaction with colleagues in both broader R&D teams and Commercial Operations teams.
• The role holder will represent and role model scientific excellence within the department.
• Work in collaboration with line and project managers to ensure that science and technology that is implemented in projects is world class.

Reporting Relationship

• Direct Reports – typically 0
• Indirect Reports – typically 0

Budget Responsibility

Based on science project initiatives.

Measure of Success

• Regulatory submissions to both Global and China Agencies to support AstraZeneca development projects.
• Delivery of robust and efficient Drug Product analytical methods, specifications and control strategies to Commercial Operations group.
• Evidence of innovative scientific contribution to projects that make a difference to patients.
• Effective technical supervision and coaching of scientific staff for more effective contribution to projects.
• Giving the GPD a strong scientific impact in Pharmaceutical Technology and Development.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.