The Senior Director's is responsible for leading and directing the viral vector purification activities for Alexion's AAV production platform. The Senior Director will collaborate with key functional experts in our Research, Product Development, and Analytics teams, among others to advance our growing portfolio. The incumbent will be part of the Viral Vector Product Development Leadership Team in defining overall strategy, team growth, budgeting, and providing expertise to project team on all aspects of downstream process development.
You will be responsible for:
Accountable for all downstream development activities, including life-cycle management, externalization, due-diligence, academic partnerships, and in-licensing, across the entire product life-cycle, from pre-clinical to commercialization.
Provide product development leadership and strategy on project teams (or mentoring junior Project Leaders) and collaborating across all areas of CMC and clinical development functions from early discovery into development
Collaborate on the development of innovative technologies and with the Formulation team to establish systems with appropriate quality and stability.
Identifying, negotiating, and delivering partnerships with academic institutions or industry to evaluate, development and implement new technologies and improved workflows.
Establish positive relationships across AstraZeneca teams to share innovative technologies
Provide subject matter expertise for regulatory interactions including inspections, audits, and is accountable for the technical content of process development sections of regulatory submissions.
Lead and develop an innovative team of process development scientists.
Devote significant time and effort in developing colleagues and the requisite bench strength to deliver on Alexion's growing R&D pipeline.
You will need to have:
The successful candidate will have 10+ years of process development experience with direct experience in AAV and late-stage molecular biologics development, including participation in projects involving cross-functional teams
Must be proficient in downstream state-of-the art technologies to establish viral vector systems in compliance with global regulatory standards and guidance.
Knowledge of current regulatory guidelines and cGMP requirements is essential. Knowledge of preclinical and clinical drug development is a prerequisite
Direct experience in preparing and supporting regulatory submissions including INDs/CTAs, BLA/MAAs and engaging with regulatory agencies is required. Be a key subject matter expert in for CLD activities when working with CMOs, Quality, Commercial, and other key stakeholders, both internal and external.
The candidate will have people-leadership, management, and development expertise, with a proven history of leading, prioritizing, and managing multiple successful projects and support strategy thinking and actions.
Well-developed leadership, communication, team building and influencing skills; unquestioned integrity; and the experience to help establish a global function that is critical to our organization's success
Ability to travel up to 20%
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
Bachelor's, Master's, or Doctorate degree or equivalent in Pharmaceutical Sciences, Bio/Chemical Engineering, Biochemistry, Molecular Biology, or related discipline.
At least 8+ years of experience (from Doctorate) in managing a process development group with direct deep expertise in developing processes from pre-clinical through licensure of viral vectors, gene therapies, and/or molecular biologics
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.
