Senior Principal Scientist, Advanced Experimental Design and Automated Optimization

This is what you will do:

Alexion's Product Development and Clinical Supply (PDCS) organization is seeking a stong CMC development professional to serve as an authority leading the build-out of our capability in experimental design, empirical modeling, and machine learning, in support of drug substance and drug product process characterization and optimization. The Senior Principal Scientist will demonstrate expertise in statistical experimental design, automated data aggregation and data visualization, statistical analysis, and closed-loop optimization techniques to accelerate development of safe, robust, and cost-effective pharmaceutical manufacturing processes.

You will be responsible for:

• Building an innovation ecosystem for the development and deployment of experimental design strategies, statistical analysis tools, and machine learning techniques for Alexion synthetic modalities (small molecules, peptides, and oligonucleotides).
• Applying statistical design and analysis strategies, coupled with machine learning techniques, to accelerate the development of safe and scalable manufacturing processes that decrease costs, optimize process efficiency, and improve product quality.
• Providing expert consultation to CMC process development teams on our most complex experimental design and statistical analysis challenges.
• Demonstrating strong in-laboratory presence to develop closed-loop process optimization workflows for deployment across the Alexion synthetic product development portfolio.
• Representing Alexion as authority in interactions with peers within AstraZeneca, and across the industry.
• Providing technical expertise to enable authoring of Module 3 content for regulatory submission documents that convey phase-appropriate scientific understanding, spanning IND/IMPD through NDA/MAA.
• Statistical and data-driven insights to formulate integrated and comprehensive CMC control strategies for NDA/MAA.

You will need to have:

• Ph. D. in chemical engineering, organic chemistry, analytical chemistry, biochemistry, or related scientific field with 15 years industry experience in pharmaceutical, agrochemical, and/or fine chemical process development.
• Proven ability to design, implement, and interpret data-rich experiments.
• Expert hands-on laboratory skills, and desire to grow as a research scientist via technical excellence in the laboratory.
• Technical expertise to remain abreast of the latest scientific trends pertaining to advanced experimental design and automated knowledge generation in the pharmaceutical industry, and to evaluate emerging technologies.
• Intimate understanding of the design, development, optimization, and scale-up of pharmaceutical manufacturing processes.
• Familiarity with cGMPs and pharmaceutical regulatory guidances.
• Up to 15% travel, with ability to work independently of remote locations.
• 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. In addition, employees in this role must be able, with or without an accommodation to: pass a medical evaluation; wear a respirator while maintaining a tight fitting seal to the face.

We would prefer for you to have:

• Prior hands-on experience (academic or industry) in the use of online process analytical tools to accelerate development and enhance control of continuous manufacturing processes.
• First-hand experience in the design of multi-step continuous drug substance manufacturing processes, and supervising cGMP implementation at CMOs.
• Prior experience in process safety and process hazards analysis!
• Prior industrial experience with the development, scale-up, and cGMP manufacture of synthetic peptide drug substances.
• Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working give 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.

Date Posted

15-Mar-2024

Closing Date

27-Jun-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.