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. 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 ambitious world. 

The annual base pay for this position ranges from $138,393 to $207,589. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as 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.

At AstraZeneca, you'll find an environment where diversity is celebrated, ideas are valued, and inclusion is championed. Our patient-driven culture fosters connections that lead to groundbreaking innovations impacting lives globally. With a rapidly expanding portfolio, you'll enjoy the entrepreneurial spirit of a leading biotech while being supported by exceptional leaders. Here, your career journey aligns with our mission to make a difference where it truly counts. 

Ready to make an impact? Apply now to join our team! 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.