Short role description

Leads formulation and process development activities for new molecular entity. Ensure suitability of all development work to meet the regulatory requirements of Global and China CMC submission.

Typical Accountabilities

• Leads formulation and process development activities for new molecular entity. Author Drug Product sections for CMC dossier submissions, suitable for Global and China submission. Lead technical transfer between AstraZeneca sites for Clinical or Commercial Manufacture. The role holder needs to have sufficient experience to lead these activities independently.
• Acts 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 (CDMOs). Presents work through patents, publications and lectures as needed.
• Maintain good knowledge of the external regulatory environment.
• Takes responsibility for the quality, communication and delivery of science in projects. Contributes to constructive scientific debate during project technical reviews across the portfolio. Provide expert technical guidance, challenge and problem solving in projects.
• 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. Demonstrate creativity and innovation on projects.
• Be an active member of scientific discipline networks.

Education, Qualifications, Skills and Experience

Essential

B. Sc., M. Sc., or Ph. D. Degree in Chemistry, Pharmaceutical Sciences or related discipline. Typically 10 years’ experience working in a pharmaceutical development technical / industrial environment with a B. Sc., 8 years’ experience with a M. Sc., and 5 years’ industrial experience with a Ph. D. degree.

Have a good understanding of the overall drug development process with an appreciation of how CMC development contributes to R&D. Recognized as expert in own area of scientific discipline and often seen as point of reference for others.

Excellent communication skills both verbally and in writing in both Chinese and English.

Desirable

Good team working and networking skills and an ability to influence others and engage relevant AstraZeneca staff in new initiatives. Capable of building good relationships with customers across functions.

In-depth knowledge and experience in specialized field. Works independently requiring only minimal guidance. Able to leverage internal and external resources to solve complex problems. May act as a coach or team leader for technicians or lower level scientists.

Demonstrated a proven track record of delivery and experience in product development.  Experienced in authoring and submission of CMC dossiers and answering subsequent regulatory questions. Experience of technical supervision, coaching and mentoring or leading small teams of people or scientific projects.

Date Posted

09-9月-2021

Closing Date

30-10月-2021

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.