Associate Director, Bioanalysis Genomic Medicine

Join our dynamic team dedicated to developing novel therapeutics and transforming patient lives through bioanalytical science. In this role, you will represent Bioanalytical Development on project teams, leading the creation and implementation of bioanalytical strategies in collaboration with your department. You will support a diverse range of therapeutics, particularly focusing on genomic medicine candidates, and provide bioanalytical project leadership within cross-functional teams. Your responsibilities include bioanalytical method selection, guiding internal method development, coordinating with CRO partners for method transfer and sample analysis, ensuring regulatory compliance and engaging with regulatory agencies regarding specific bioanalytical methods. Additionally, you will contribute to the bioanalytical sections of regulatory documents such as IND, NDA/BLA, IB, and CSRs.

Accountabilities

• Serve as the BA Project Lead providing input on PK, PD and immunogenicity assays
• Develop bioanalytical strategies and plans for therapeutics at various stages of late research through clinical development
• Lead the implementation of the bioanalytical strategies, working with both internal staff scientists and CROs, in developing, qualifying, and validating key assays, and ensuring sample analysis is completed on time
• Accountable for the compliance of regulated bioanalysis with good laboratory practices (GLP), OECD regulations, FDA, EMA, PMDA and other relevant global bioanalytical and immunogenicity guidance documents
• Lead the interpretation of bioanalytical data provided to project teams
• Responsible for the preparation of BA sections of study protocols, reports, sections of IND, IMPD, BLA/MAA, EOP2 meetings and other regulatory documents

Essential Skills/Experience

• Doctoral degree (PhD) in biology, biochemistry or relevant field is preferred
• A minimum of 8 years of pharmaceutical proven experience with minimum of 4 years supporting regulated bioanalysis in non-clinical and clinical studies
• Solid understanding of bioanalytical assay development for biologics and genomic medicine drug candidates, and experience in managing bioanalytical projects
• Strong knowledge in GxP regulations that pertain to Bioanalytical Development
• Experience writing documents to be included in regulatory submissions for NDA/BLA and meeting with regulators to discuss the bioanalytical package that is included in the final NDA/BLA submission
• Willingness to potentially travel approximately about ~10% of the time

Desirable Skills/Experience

• Experience in supporting genomic medicine projects (gene therapy, gene editing, and cell therapy) is desired
• Experience selecting and managing CROs is desirable
• Strong management skill and capability; experience with regulatory agency inspections is a plus

When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we champion diversity and foster an energizing culture where people build connections to explore new ideas that profoundly impact patients' lives. Here, diversity and different thinking are valued, and inclusion is championed so those life-changing new ideas can come from everywhere. We celebrate and reward each other, ensuring kindness remains as important as our ambition to succeed for those in need. We take pride in giving back to the communities in which we operate.

Ready to make a difference? Apply now!

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.