This is what you will do:
The Director role is a strategic, scientific, and technological role that involves leading independent functional level objectives for downstream biologics therapeutics pipeline development for Alexion, Rare Disease Business Unit of AstraZeneca.
The Director is responsible for managing a direct and matrix team of managers, scientists, and development associates to achieve functional level objectives to support CMC development of early, late and commercialization of biologics therapeutics as well as working on intensifying downstream bioprocesses with an aim to reduce COGS, increase robustness and speed to clinic and launch.
This role will work closely with other functions within drug substance process development group and with other groups within Process Development and Clinical Supply (PDCS), Research, Operations, Quality (QA), Regulatory (RA), AstraZeneca network and external vendors. The successful candidate must have mature team-working behaviors and organizational awareness and insight.
You will be responsible for:
Leading a group of downstream scientists and engineers to develop, design and scale up downstream and harvest processes for Alexion’s entire biologics pipeline from pre-clinical support to early, late, and commercial process development
- Assist and mentor colleagues for efficient and successful development and technology transfers of Drug Substance to internal and external manufacturing organizations in a phase appropriate manner
- Co-leading interface on new capabilities and cross-functional interactions with other teams to implement technological innovation including process intensification and advancing new biologics modalities
- Leading and developing downstream control strategy for process performance qualification for late phase biologics processes
- Partnering with operations to develop lifecycle management approach for commercial biologics and lead second generation downstream process development
- Leading and managing cross-functional interactions with other process development teams and develops effective collaborations with internal functions within process development, process engineering in AZ network and, broader PDCS, Research, Operations, QA, RA organizations to advance functional goals
- Leading troubleshooting for complex deviations to support GMP manufacturing throughout lifecycle of biologics pipeline in partnering with QA and Operations as applicable
- Leading and collaborating with EHS in maintaining high standard of laboratory safety per current regulations
- Authoring internal, reports, regulatory facing documents, provide summaries and internal and external steering committee presentations, and provide executive summaries to senior leadership on functional updates
- Actively participating in and occasionally leading relevant industry wide forums to have up to date knowledge on functional area specific fields
You will need to have:
PhD in biological sciences, biochemistry or chemical engineering or related field with 8+ years of relevant experience, or BS with 15+years of relevant experience or MS with 14+ years of relevant experience
- Experience in managing a group of bioprocess development scientists or engineers with direct experience of developing early as well as late-stage programs through licensure
- Experience and good technical knowledge of biotherapeutic process development, scale-up, technology transfer and manufacturing with a focus on downstream and harvest process for mAbs and proteins
- Experience with process characterization using DOE and associated data analysis, process validation and Quality by Design concepts
- Proven track record of authoring, and providing critical input to regulatory submissions including but not limited to INDs, IMPDs, CTAs and BLAs
- Ability to understand the development lifecycle from R&D through commercialization, including an understanding of the interdependencies of functional groups
- Extensive working knowledge of US and worldwide drug substance regulations including cell line, upstream and downstream processes for biologics
- Must be proficient in managing multiple projects, timelines, in writing reports, project summaries, and internal/external presentations
We would prefer for you to have:
Track record of scientific publications and conference presentations
- Proven track record of implementing new technologies (e.g. continuous or connected processing, high throughput process development) in process development workflows and/or in GMP manufacturing
- Experience with process modeling, process controls, and mathematical and statistical approaches
- Knowledge in planning for program advancement to process validation and commercial launch
- Experience in cell & gene therapy field
- Good technical knowledge of other related functions of biotherapeutic process development including cell line, upstream process development, manufacturing, testing, and characterization
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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.