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Director/Senior Director Analytical Sciences
2 months ago
Join us as a Director/Sr Director, Analytical Sciences in Gaithersburg, MD and play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
Accountabilities:
As a Director/Sr Director, you will lead a group of scientists for analytical development of multiple biopharmaceutical drug candidates from clinical development through registration. You will represent Analytical Sciences and Biopharmaceutical Development in cross-organizational governance and committees to drive and steer technical and business strategies and processes. You will also lead product characterization, CQA assessment, method development/optimization, setting scientifically justifiable comparability strategies, specification and control strategies. You will author, review and approve comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings (IND, IMPD), and lead cross-functional teams to develop business processes and guidelines for coordinated early and late stage analytical development activities in support of biologics commercialization, including post-market life cycle management.
Essential Skills/Experience:
- A PhD in chemistry, biochemistry or related field with 15+ years of relevant experience.
- Significant and established experience in late stage product characterization, regulatory filing, and response to agency questions.
- Experience leading/developing staff members, including both direct reports and skip-level staff.
Desirable Skills/Experience:
- Proven scientific leader with vision in establishing analytical capabilities to support novel modalities.
- Demonstrated organizational and strategic leadership in establishing technical guidelines and business processes, as well as steering cross-organizational alignment within and outside of biologics CMC development.
- Working knowledge of innovative physicochemical characterization technologies.
- Team oriented and able to lead multiple projects cross various development stages.
- Experience interacting with process, formulation, bioassay and lot release/stability functions to ensure strong cross functional collaborations and integrated process and product development.
- Experience collaborating with business partners across global development and manufacturing network.
- Good understanding of quality systems and experience with successful internal and regulatory audits/inspections.
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 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 daring world.
At AstraZeneca, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
Are you ready to be part of a team that follows the science unlike anywhere else? This is the place for curious minds. Dig deep into the biology of complex disease and uncover breakthroughs. Our belief powers us to push the boundaries. As we improve success rates, we keep moving forward. Celebrating both successes and failures along the way. We're investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and groundbreaking innovative ways to better predict clinical success. Always advancing our scientific knowledge and helping to craft the future of healthcare for the greatest and swiftest impact on disease.
Join us in our quest to push the boundaries of science and deliver life-changing medicines
Date Posted
14-May-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.