Introduction to Role:
Join Alexion’s Synthetic Product Development (SPD) organization as an experienced analytical and control strategy development leader. Delivering phase-appropriate control strategies for Alexion small molecule and synthetic peptide programs spanning preclinical development through first commercial launch. This is an outstanding opportunity to make a significant impact on the lives of patients worldwide!
Accountabilities:
In this role, you will guide the development, optimization, and validation of analytical methods for small molecule and synthetic peptide drug substances and drug products at CROs/CDMOs. You will propose scientifically sound, phase-appropriate specifications for starting materials, synthetic intermediates, drug substances, and drug products. You will also author compelling responses to health authority queries on regulatory submission documents and represent Alexion as a subject matter expert in meetings with health authorities.
Essential Skills/Experience:
- Ph.D. in analytical chemistry, bioanalytical chemistry, or a related field with minimum 12 years proven experience in analytical and control strategy development for small molecules and synthetic peptides
- Solid understanding of current regulatory guidelines and cGMP requirements pertaining to small molecules and synthetic peptides
- Strong experience in preparing regulatory submissions for small molecules, synthetic peptides and responding to inquiries from health authorities
- Proven record of leading sophisticated technical development projects, and remotely leading development timelines at CROs/CDMOs
- Technical expertise and intellectual curiosity to remain abreast of the latest developments pertaining to small molecule and synthetic peptide control strategy, and to proactively evaluate emerging technologies and regulatory trends
- Strong understanding of the design, development, optimization, and scale-up of small molecule and synthetic peptide manufacturing processes
- Up to 10% travel, with ability to work independently from remote locations
- Experience with online process analytical techniques to accelerate development and enable enhanced control strategies for multi-step continuous manufacturing processes
- Experience with Chemometrics, multivariate data analysis, in situ reaction monitoring and reaction profiling
Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash 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 bold world
At Alexion, AstraZeneca, Rare Disease, we are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and closer to each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. We champion diversity in a patient-driven, energizing and kind culture where people build connections to explore new ideas that profoundly impact patient’s lives. Here diversity and different thinking are valued, and inclusion is fostered.
Join us in making an impact by driving change with integrity, supported by a culture that celebrates diversity, innovation, and the power of connection to patient’s lived experiences. Here, your career is not just a path, but a journey to making a difference where it truly counts.
Ready to make a difference? Apply today!
Date Posted
22-Aug-2024
Closing Date
30-Oct-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 accommodations@Alexion.com. 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.