If you have the passion and the drive to accelerate growth and make people's lives better - then AstraZeneca is the place for you. In Operations we have a big ambition - to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.
AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery. Operations is accelerating, fast. We are on track for Our Bold Ambition 2030, delivering 15+ new medicines driving us forward across different modalities including biologics, cell therapy, ADCs and small molecules.
Position Summary
The Executive Director Analytical Sciences & Technology will lead the analytical development encompassing method development, qualification, and cell therapy drug substances and drug product characterization for all cell therapy programs during product lifecycle. You will play an instrumental role in post-launch Life Cycle Management (LCM) and will be an important member of the CMC Development Leadership Team.
The position will report to the Vice president of Analytical and Process Development, Cell Therapy. The position can be based in Gaithersburg, MD or Santa Monica, CA.
Responsibilities
- Lead the Analytical Development team for cell therapy.
- Visionary leader for a current team of 30+ and growing, strategically shape the team as it continues to evolve in a fast-paced environment.
- Accountable for Methods, including development, QC support, validation, remediation, and LCM.
- Create analytical control and regulatory strategies for drug substance and drug product quality attributes.
- Drug substances and drug product characterization to define CQAs and develop phase appropriate QTPP targets for DS & DP development.
- Manage analytical testing for DS & DP development.
- Draft and approve CMC sections in regulatory filings, support agency interactions and inspections.
- Collaborate across Process Development, Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance and Technical Development for successful commercialization of late-stage portfolio.
- Work with Research, Clinical Development, and Product Strategy Teams for technical and strategic input.
- Exhibit comprehensive knowledge of cGMP practices and novel process technologies.
- Stay updated on biopharmaceutical industry trends.
- Set and balance organizational goals with immediate and long-term priorities.
- Recruit, mentor, and nurture talent.
- Oversee departmental budgeting.
Preferred Requirements
- A Ph.D./M.S. in a relevant field with 10+ years of experience in analytical development, demonstrating a progressive increase in responsibilities and an understanding of managing programs from IND submissions to MAAs.
- Large team leadership experience.
- Global experience.
Skills and Competencies
- Expert in Mechanism of Action (MOA) for defining Critical Quality Attributes (CQAs) and developing Quality by Design (QbD) control strategies for cell therapy or biologics products. Experience creating comprehensive product quality control strategies.
- Develop, qualify, and validate a variety of assays, including those for product purity, process-related impurities, flow cytometry, and cell-based potency assays.
- Experience with product characterization techniques, encompassing both biophysical methods and potency-based approaches, as well as high-throughput assay methodologies.
- Well-versed in industry best practices, guidelines, and new trends. Experience drafting regulatory documentation across all stages, including IND, BLA, and MAA submissions.
- You will demonstrate qualities such as collaboration, accountability, influence, strategic vision.
- Create Inclusion: Recognizes the value of diverse teams, models inclusion, and embed the importance of diversity in team management.
- Develop Talent: Understands the experience, aspirations, and potential of their team members, coaching them on current performance and future potential. Ensure employees receive the feedback and insights needed to develop their purpose.
- Empower Teams: Connects the team to the broader organization by aligning goals, purpose, and organizational goals, while holding them accountable. Provide the necessary support to remove barriers and integrate the team into the broader ecosystem.
When we put unexpected teams in the same room, we fuel 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 three days per week from the Gaithersburg, MD or Santa Monica, CA office. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
The annual base salary for this position ranges from $269,000 to $328,900. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted
05-Sep-2024Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.