The Senior Director of Cell Line Development (CLD) will lead and direct the production of novel viral vector plasmids and high-producing, high quality packaging and/or producer cell lines for AAV. They will also be responsible for new technology evaluations, due diligence activities, and cell line strategy across the entire product lifecycle. They will be responsible for all aspects cell line generation, including raw materials, adventitious agents, and project planning. Accountable for authoring technical reports and cell line sections of Regulatory sections for world-wide regulatory submissions through successful licensure. They will work closely with key stakeholders in Research, Development, Quality, and Global Regulatory Affairs on cell line development strategy and phase-appropriate product details. The incumbent will be a key member of the Viral Vector Drug Substance team, providing input on the team strategy, including budgeting and internal resources. They will devote significant time and effort in developing colleagues and the requisite bench strength to deliver on Alexion's growing viral gene therapy pipeline.
Responsibilities
The Senior Director, Cell Line Development will be part of the Viral Vector Drug Substance (VVDS) Leadership team. They will support the Head of VVDS in budget and internal resources strategy
The incumbent is accountable for all cell line development activities, including externalization and in-licensing, across the entire product life-cycle, from pre-clinical to commercialization.
They lead and develop an innovative team of molecular and cell biology scientists.
Leading projects and/or providing leadership to junior Project Leaders for multiple programs from early discovery into development
Direct the development and characterization of the plasmid vectors and high-productivity cell lines. Will collaborate closely with research and Drug Substance process development teams to establish systems with appropriate quality and expression levels.
Providing early development leadership and strategy on project teams and collaborating across all areas of pharmacology, CMC, and clinical development functions
Establishing positive relationships within the AstraZeneca discovery team to share innovative technologies
Identifying, negotiating, and delivering partnerships with academic institutions or industry to evaluate, development and implement new technologies and improved workflows.
Provide subject matter expertise for regulatory interactions including inspections, audits and is accountable for the technical content of cell line development sections of regulatory submissions.
Collaborate with appropriate stakeholders to identify and deliver on life-cycle management opportunities for commercial products with respect to next generation processes.
Actively seek and achieve alignment on CLD strategies within the VVDS and PDCS teams with key stakeholders in Research, Global Operations, Global Regulatory Affairs, Quality, and Commercial organizations.
Devote significant time and effort in developing colleagues and the requisite bench strength to deliver on Alexion's growing R&D pipeline.
Qualifications
The successful candidate will have 10+ years of cell line development experience with direct experience in AAV and late-stage molecular biologics development, including participation in projects involving cross-functional teams
At least 8+ years of experience in managing a cell line development group with direct deep expertise in developing cell lines from pre-clinical through licensure of viral vectors, gene therapies, and/or molecular biologics
Must be proficient in cell line development analytical tools and state-of-the art technologies to establish viral vector plasmid systems and cell lines 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 track record 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
Education
Must have a BS/MS/PhD or equivalent in Pharmaceutical Sciences, Bio/Chemical Engineering, Biochemistry, Molecular Biology, or related discipline.
Competencies
Leadership
Accountability
Collaboration
Decision making
Change management
Perseverance
Problem Solving
Results oriented
Developing Direct Reports and Others
Hiring and Staffing
Managing Performance
Motivating Others
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.
