Manager / Sr Manager, R&D - Purification Process Sciences

Job Description

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration through scientific research. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

Location,: Gaithersburg, MD

AstraZeneca has an opening for a Manager / Sr Manager in Gaithersburg, MD. We are seeking a highly motivated downstream technology transfer (TT) and manufacturing support professional. This position will manage a team responsible for transfer of downstream processes from development into clinical and commercial manufacturing. The position resides within the Purification Process Sciences (PPS) department (within Research and Development). 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.

Responsibilities:

• Responsible for process TT activities including: fit-to-plant, process risk analysis, timely generation of TT documentation, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support, and campaign summary report authoring
• Serve as Drug Substance Process Technical Lead for TT of projects to commercial and contract manufacturing organizations
• Manage lab-scale experiments to support process changes, generate robustness data, and/or resolve manufacturing non-conformances
• Proactively influence process decisions to help avoid non-conformances
• Provide input on process development and manufacturing strategies
• Author/review technical reports and deliver presentations utilizing sound scientific reasoning and interpretation of the available data
• Author/review IND/BLA sections and responses to questions to support regulatory filings
• Builds and maintains relationships with partners, collaborators, departments and contractors.
• Contribute to the improvement of the TT business processes through idea generation, team leadership, and implementation

Required Skills:

• Downstream TT 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
• Experience as people manager in matrix team environments, ability to work with various subject matter experts and drive successful completion of team goals
• Knowledge of GMP manufacturing principles and documentation
• Demonstrated critical thinking skills
• Excellent written and verbal communication skills
• Demonstrated ability to outline issues, assess and present risks/benefits, and ability to make recommendations with limited data using sound scientific reasoning
• Skilled in effectively explaining complex scientific or engineering concepts to a broad and diverse cross-functional audience
• Demonstrating initiative and drive for results
• Proven experience in preparing detailed and thorough technical protocols and reports

Desirable Skills:

• Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory
• Experience with biopharmaceutical modalities in addition to recombinant proteins and/or monoclonal antibodies such as antibody-drug conjugates, viral products, nucleic acids and/or cell therapies
• Comprehensive knowledge of commercialization activities (process characterization, validation, BLA preparation and inspection support) for biopharmaceutical products
• Experience transferring and/or supporting commercial products
• Skilled in conducting complex transfer/process development/technology development projects
• Familiarity with statistical software and Monte Carlo simulations

Supervision

This position does not require direct supervision but will require management of matrix teams

Education

A minimum of a bachelor’s degree in an engineering or scientific discipline with a focus in a biochemical engineering field (e.g., chemical or biochemical engineering) is required.

Experience

The candidate must have industry related experience

Manager: (BS and 10+) or (MS and 8+) years of relevant experience

Sr Manager: (BS and 13+), (MS and 10+), or (PhD and 3+) years of relevant experience

*Position may require weekend work and/or periodic late-nights (campaign support) and possibly some travel to CMO or other sites (domestic and international).