Sr. Director, Viral Vector Cell Line Development

Position Summary

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

Date Posted
01-Apr-2024

Closing Date
30-Jun-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.