AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re proud to have a unique workplace culture that inspires innovation and collaboration through scientific research. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.
Director, Analytical Sciences
As a Director, Analytical Sciences in Gaithersburg, MD you’ll 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.
AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and Responsibilities
- Lead analytical development for multiple biopharmaceutical drug candidates from clinical development through registration.
- Represent Analytical Sciences at CMC teams. Establish analytical team, development plan and timeline to meet CMC team needs.
- Represent Analytical Sciences and Biopharmaceutical Development in cross-organizational governance and committees to drive and steer technical and business strategies and processes.
- Lead product characterization, CQA assessment, method development/optimization, setting scientifically justifiable comparability strategies, specification and control strategies.
- Represent Analytical Sciences and Biopharmaceutical Development in verbal and written communications with regulatory agencies, AstraZeneca senior leadership meetings, R&D product development teams for all therapeutic areas.
- Author, review and/or approve key documents such as: comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.).
- Lead cross-functional team to develop business processes and guidelines for integrated early and late stage analytical development activities in support of biologics commercialization, including post-market life cycle management.
- Advance AstraZeneca scientific and regulatory approaches via active participation and leadership across industry groups and conferences.
Essential Requirements
- A PhD in chemistry, biochemistry or related field with 15+ years of relevant experience.
Desirable Requirements
- 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.
- Significant and established experience in the biopharmaceutical industry with relevant experience in late stage and commercial product characterization, risk assessment, method development, optimization, validation, regulatory filing, and response to agency questions.
- Working knowledge of state-of-the-art physicochemical characterization technologies.
- Experience with regulatory submissions (IND, BLA, MAA, JNDA). Deep understanding of regulatory requirements for development and commercialization of biopharmaceuticals.
- Experience leading/developing staff members, including both direct reports and skip-level staff. Provide technical advice to analytical scientists and associates, where needed, to assure the highest quality of data is developed and presented.
- Excellent oral and writing skills.
- Team oriented and able to manage 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 interfacing with business partners across global development and manufacturing network
- Good understanding of quality systems and experience with successful internal and regulatory audits/inspections.
- Demonstrated scientific thought leader in expanding analytical capabilities to support biological products of different modalities.
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