Associate Principal Engineer, Antibody Drug Conjugates - Process
Gaithersburg, MD, United States
Are you ready to make a significant impact on patients' lives? As the Associate Director of Antibody Drug Conjugate (ADC) Manufacturing Process, you will be responsible for developing, characterizing, and validating conjugation and associated purification platform unit operations within our biologics Global Technical Operations (GTO). You will work closely with BioPharmaceutical Development and other members of the New Modalities Team to build the requisite technical knowledge to plan and execute activities internally and/or at third parties.
Accountabilities:
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.
Desirable Skills/Experience:
• -Master’s or Ph.D. degree is preferred.
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Why AstraZeneca?
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!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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