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Scientist I/II - Downstream - BPD

Lieu Gaithersburg, Maryland, États-Unis Job ID R-057628 Date de publication 08/02/2019

As a Scientist I/II in Bioprocess Technology and Engineering (BTE), you would join a team exploring and evaluating novel methods of development and manufacturing for purification of biological therapeutics, including antibodies, bispecific antibodies, and Fc-fusions. Gene and cell therapies are also possible modalities. You would work on a matrix team with members from cell line development, cell culture development, purification development, analytical development, formulation development, and data analytics and modelling.    

Initially, innovation would focus on the development of intensified downstream unit operations and process analytical technologies for next generation manufacturing of protein-based therapeutics. This platform would involve integrated and continuous manufacturing to enhance flexibility and productivity.  The role would focus on the demonstration of integrated upstream and downstream methods and equipment at mid-scale with some proof of concept work at small scale.  

In addition, you will interface with Quality, Engineering, Validation, Manufacturing, and Development to solve downstream production issues. You will apply scientific and engineering principles, theories and concepts to assist investigation, scale-up specification, and process controls of downstream operations. You would be a member of a matrix teams of scientists and engineers focused on process engineering and technology development/implementation projects and may lead aspects of some projects.  You will present at internal departmental and cross-functional meetings, and may participate and present at external meetings.

Education Requirements:

A Bachelors, Masters or PhD Degree in a scientific or engineering discipline with a focus in a process engineering field (e.g., chemical or biochemical engineering) is strongly preferred.

Industry related experience:

  • Sci I (BS 10-13, MS 8-10, PhD 0-3)
  • Sci II (BS 13-15, MS 10-13, PhD 3-7)

Industrial experience developing or supporting clinical or commercial biotechnology is preferred. Demonstrated leadership through project team participation, internal consulting, and mentoring.

Preferred Qualifications:

• Fundamental understanding of downstream unit operations such as mixing, batch chromatography, multi-column chromatography, filtration (particle removal, virus removal, and UF filtration) and precipitation methods.

• Knowledge of GMP manufacturing principles is desired.

• High level knowledge of the drug development process, global regulations, process validation and ICH guidelines is desired.

• Experience with GMP equipment design and use of data management systems.

• Skilled in conducting complex research projects.

• Skilled in problem-solving.

• Skilled in effectively explaining complex scientific or engineering concepts to a broader, diverse, cross-functional audience.

• Anticipates and resolves project priority conflicts.

• Ability to travel occasionally to conferences and global manufacturing sites (approximately 10-20% time required for travel).

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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