Sr. Scientist - Purification Process

Do you a passion for bringing new medicines to patients? Would you like to apply your expertise to impact the manufacturing success of clinical and commercial products in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

AstraZeneca has an opening for a Senior Scientist in Gaithersburg, MD in the Purification Process Sciences-Technical Transfer team (PPS-TT). We are seeking a highly motivated downstream technology transfer and manufacturing support professional. This position will be responsible for transfer of downstream processes from development into clinical and commercial manufacturing. Members of the TT group within this department work closely with the process development scientists (located in the US and UK), clinical/commercial manufacturing organizations, CMOs, and QA to ensure appropriate scale up and transfer of clinical and commercial processes to manufacturing production.

Main Duties and Responsibilities

Transfer multiple projects as downstream tech transfer project lead/ representative. Serve as downstream process SME to perform fitto-plant, process risk analysis, timely generation of tech transfer documentation, batch record review/approval, technical collaboration with receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support, campaign summary report authoring, and routine presentations to multi-functional teams and the management

• Build and maintain effective working relationships with internal stakeholder groups and external CMOs to successfully advance AZ’s Biologics portfolio. Proactively addresses risks/issues to avoid non-conformances and enable efficient transfers

• Serve as subject matter expert and provide technical support to manufacturing within AZ and external partners

• Effectively communicate and collaborate in a matrix team setting to implement technical solutions

• Author, review, and approve technical documents, CMC sections of regulatory submissions (INDs/BLAs), and responses to questions from health authorities.

• Contribute to the improvement of the tech transfer business processes through idea generation and implementation activities

• Position may require weekend work and/or periodic late-night calls (manufacturing support or international collaborations). Position may require travel to CMOs or other AZ sites (domestic and international)

Education & Experience Requirements:

Education: Minimum BS or MS in an engineering or scientific field such as biological sciences or chemistry. A focus in a process engineering field (e.g., chemical, or biochemical engineering) is preferred but not required.

The candidate must have industry related experience.

Senior Scientist required experience: (BS and 10+), (MS and 8+), (PhD and 2+) year

SKILLS AND CAPABILITIES

Essential for the role • Downstream Technical Transfer and process development experience • Comprehensive knowledge of chromatography columns, virus and sterilizing-grade filters, and TFF membranes (bench, pilot and production scale) • Fundamental understanding of downstream unit operations such as affinity, ion exchange, and hydrophobic interaction chromatography, low pH and surfactant-based viral inactivation, virus filtration, and UF/DF • Working knowledge of scale-up/scale-down principles • Broad understanding of CMC activities and responsibilities with respect to TT • Knowledge of GMP manufacturing principles and documentation

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.