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Sr Scientist, Purification Process Sciences

Location Gaithersburg, Maryland, United States Job ID R-077781 Date posted 03/20/2020

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.

Functional lead for pipeline portfolio projects.  Responsible for design, optimization, and/or characterization of downstream processes for manufacture of monoclonal antibodies and other proteins in late stage development, including validation through commercial launch.  

Key Responsibilities:
• The Sr Scientist will be responsible for supervising the planning and execution of all late stage downstream development activities for one to two concurrent projects or one accelerated project.  Includes process characterization, scale-down model verification, definition of control strategy, technology transfer/process validation, BLA/marketing application strategy/authoring, and addressing information requests from health authorities.  Able to lead and prioritize to ensure delivery in a matrixed organization in the face of rapidly changing and complex project plans.


• This role will be an emerging leader in building platform capabilities (strategy and execution) in late-stage development to BLA, including cross-functional initiatives and collaborations on common and integrated approaches to support the increasing complexity and acceleration of the AstraZeneca late stage portfolio.


• The Sr Scientist will represent purification development on cross-functional CMC teams.  Coordinates efforts with CMC Regulatory, Quality, Operations, and other R&D groups in order to meet project timelines and company goals. Experience preparing regulatory documents (e.g., BLAs and MAAs) is essential, together with a good working knowledge of GMP and Quality issues.


• This role will utilize good working knowledge of drug development, including protein chemistry, protein purification, process design. Can solve problems through formal channels and informal networks.  Work is performed with limited direction.  Demonstrated leadership through project team participation, internal consulting and mentoring.  Demonstrates ability to resolve conflicts between team members.  Demonstrates the ability to effectively explain complex scientific concepts to a broader, diverse audience.  Frequent inter and intradepartmental collaborations. Has external alliances.


• The Sr Scientist will engage in statistical design of experiments as well as identification of critical process parameters, in-process control limits, and scale-down model verification. Must be proficient in protein purification, including process chromatography, filtration, and process characterization. Expected to be knowledgeable in viral clearance, formulation, and product characterization/critical quality attributes.  Expected to analyze and interpret analytical and process data and understand the process and regulatory implications. Will be expected to effectively assess process capability and impact of process parameters and material attributes on product quality and process performance.


• This role may provide the opportunity to serve as line manager for junior scientific staff operating in a highly matrixed environment.


Requirements:

- Requires a Ph.D or MS in chemical/biochemical engineering, biochemistry, or related field

- PhD with a minimum of 7 years of relevant postdoctoral and/or industrial experience OR MS with a minimum of 13 years of relevant experience.

- Expertise/experience strongly desired in late stage process development, preparation/review of BLAs/marketing authorization applications, technology transfer, and process validation.

- Good understanding of statistical design of experiments and the ICH concepts of quality by design, risk assessments, and control strategy are strongly preferred.  

- Prior supervisory experience is required (line management and/or matrix management).

- Excellent oral and written communication skills are essential.

- Prior GMP experience is a plus.

- Able to prepare/review/approve documents such as development reports, tech transfer documents, batch Production Records, and validation protocols and reports.

- Familiar with computer software including word processing, data evaluation, statistical packages.

- Familiar with protein purification equipment at laboratory and process scale. Demonstrated ability to manage complex projects.



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 authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.