Associate Principal Engineer, Antibody Drug Conjugates - Process
AstraZeneca
- Gaithersburg, MD
- Permanent
- Full-time
Your role will involve leading activities related to ADC conjugation and associated purification unit operations platforms within Biologics GTO to achieve optimized manufacturing processes regarding productivity, product quality and SHE (Safety, Health & Environmental). This will involve building the requisite technical knowledge to plan and execute the development, characterization, and validation of relevant unit operations internally and/or at third parties with other departments.Essential Skills/Experience:
- Bachelor’s degree in engineering, biochemistry or related field: 12+ years of experience with Bachelors degree; 9+ years with Masters; and 6+ years with Ph.D.
- Minimum of ten years of significant engineering or operational experience.
- Excellent problem-solving abilities.
- Strong interpersonal, organizational, collaboration and communication skills.
- Demonstrated ability to develop, characterize (involving DOEs) and validate (performance qualification) drug substance purification manufacturing processes.
- Deep knowledge of ADC conjugation:
- Chemistries (mabs, linkers and cytotoxic payloads), process parameters affecting yield and product quality like purity (i.e. generation of product-related substance impurities) and potency.
- Associated purification unit operations such ultrafiltration/diafiltration (UF/DF) and various modes of chromatography (ion exchange, hydrophobic interaction, multi-mode).
- Knowledge of current Good Manufacturing Practices (cGMPs) and relevant SHE (Safety, Health & Environmental) laws, regulations, and guidance, especially those related to the conjugation operations.
- Experience leading a project with cross-functional internal and external teams.
- -Master’s or Ph.D. degree is preferred.
In Operations we have a big ambition. To deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking. We are driven by our commitment to deliver accelerated growth for AstraZeneca and to make people's lives better. It pushes us to keep building on our foundations and progressing as we turn our ever-growing and increasingly complex pipeline from molecule to medicine. Be part of evolving how we work with Lean, cutting-edge science, digitalisation and sustainable practices.Are you ready to embrace a long-term, varied career in a fast-paced, growing environment? With a huge variety of global opportunities and learning from other teams this is the place to embrace lifelong learning and build capabilities, setting your own direction and pace. Apply today!Date Posted 14-Mar-2024Closing Date Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.