Associate Director, Upstream Process Development

Introduction to role: 

Are you ready to own the charge in developing next-generation upstream manufacturing processes? As an Associate Director at Alexion AstraZeneca Rare Disease, you'll orchestrate critical initiatives for biologics therapeutics pipeline development. This pivotal role involves leading a dynamic team of managers, scientists, and associate scientists to drive innovation in upstream process development. Collaborate with various functions within AstraZeneca and external partners to ensure seamless CMC development from early stages to commercialization. If you possess mature team-working behaviors and organizational insight, this is your opportunity to make a significant impact! 

Accountabilities: 

• Functional and technical ownership of perfusion-based intensified fed-batch (iFB) and integrated dynamic bioprocess (IDB) upstream processes for Alexion’s entire biologics pipeline from pre-clinical support to early, late, and commercial process development. 

• Functional and technical ownership of perfusion-based iFB and IDB platform processes for Alexion’s early-stage biologics pipelines. 

• Functional and technical ownership in support of development and tech transfer of upstream control strategy for iFB and IDB processes. 

• Partner with Alexion operations to develop lifecycle management approach for commercial biologics by applying next-generation upstream processes. 

• Lead and handle cross-functional interactions with other process development teams and develop effective collaborations with internal functions within process development, process engineering in AZ network, and broader PDCS, Research, Global Operations, QA, RA organizations to advance functional goals. 

• Lead new capability development teams and cross-functional interactions with other teams to implement technological development and innovation. 

• Lead a group of scientists (matrix managers) and associate scientists to support professional development and functional level objectives. 

Essential Skills/Experience: 

• PhD in biology, biotechnology, biochemical engineering, chemical engineering, or related fields with 6+ years of relevant experience, MS with 12+ years of relevant experience, or BS with 14+ years of relevant experience in bioprocess science and development. 

• In-depth technical knowledge of upstream perfusion-based process development, scale-up, and tech transfer for biologics. 

• Extensive working knowledge of biological drug substance process development, manufacturing, analytical testing for biologics. 

• Consistent record of authoring and providing critical input to regulatory submissions and inquiries to INDs, IMPDs, CTAs, and BLAs. 

• Strong capability to develop daring but achievable project plans to ensure effective and timely execution. 

• Strong capability to communicate program progress, issues, and mitigation plans to management. 

• Strong learning agility and ability for people management and leadership cross-functional teams. 

• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. 

Desirable Skills/Experience: 

• Experience in molecular biology and medium and feed development. 

• Working knowledge of regulatory guidelines related to cell line, upstream, or downstream development and process characterization including viral clearance and process validation. 

• Working knowledge and expertise on statistical analysis and process modeling. 

• Strong verbal and written communication and interpersonal skills. 

• Experience in influencing and collaborating with peers and external partners to achieve meaningful outcomes and build business impact. 

• Consistent record with strong passion and dedication to implement process science and innovation into routine biologic process development. 

When we put unexpected teams in the same room, we unleash 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. Bu