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Associate Scientist II/ Scientist I - Fill-Finish Process Development & Engineering - BPD

Location Gaithersburg, Maryland, United States Job ID R-077169 Date posted 03/12/2020

This position can be filled at either the Associate Scientist II or Scientist I level.

Primary responsibilities will include:

1) Technical Leadership: Contribute to the operation of a fill-finish pilot laboratory with lab scale capabilities including vial and syringe filling, lyophilization, and device assembly.  Develop risk assessment tools, study protocols and report templates.  Mentor and teach process design, development and engineering concepts to staff members.  Provide technical rigor in experimental design and data analysis across projects.  Carry out ongoing academic, regulatory and vendor literature review, maintain cutting edge technical knowledge, and communicate findings to team.   Build technical capability in manufacturing technologies for cell and gene therapy.

2) Process Characterization: Perform risk analyses and conduct laboratory or engineering studies at manufacturing sites to characterize processes.  Test, analyze and interpret a range of protein and peptide characterization assays (e.g. HPLC, UPLC, HIAC, MFI, cIEF).  Design process steps, establish associated operational design space and control strategy.  Support engineering and clinical fills at GMP fill-finish sites.  Review and approve batch records, validation protocols, and other GMP documents.  Provide on-site support of fills, provide support to investigations and evaluate non-conformances.  Regulatory writing responsibilities include supporting clinical and commercial filings.

3) Tech Transfer: Assist or lead late-stage and commercial technical transfer of fill-finish and device assembly processes to internal or contract manufacturing facilities for biopharmaceutical drug products. Serve on an internal sending unit team including development functions (formulation, process, device, analytical, packaging), operations, supply chain, project management and QA.  Manage timelines and activities internally, communicate goals and track deliverables at the receiving site.  Manage TT documentation effectively.  Some travel is required (typically 5 – 15 trips per year) in the US and abroad. 

Education & Experience:

Educational requirements include a degree in chemical, pharmaceutical or mechanical engineering, chemistry, materials science, or a related engineering or pharmaceutical science field.

Associate Scientist II: Bachelor's degree and 8+ years OR Master's degree and 5+ years of experience.

Scientist I: Bachelor's degree and 10+ years' experience OR Master's degree and 8+ years' experience OR PhD and 0-3 years' experience in a relevant Engineering discipline.

The candidate should have capability, skill and/or knowledge in most of the following areas:

  • biopharmaceutical drug product development
  • fill-finish unit operations including formulation, mixing, filtration, fill and lyophilization
  • biopharmaceutical degradation pathways and mechanisms
  • QbD, experimental design, statistics, modeling
  • technical writing and documentation
  • cGMP, aseptic processing , and related regulatory literature
  • ability to handle multiple ongoing work streams in an organized fashion 

Experience:

Suitable experience may include development of fill-finish, lyophilization, device assembly, or related processes.  A high degree of self-motivation and technical rigor is required.  Strong communication and technical writing skills are essential.  Experience organizing and leading cross-functional teams is valuable.  Though this position is in Development, we will consider strong candidates with GMP processing experience, e.g. in technical services, project management, QA or validation. We will also consider strong candidates from a device development or small molecule parenteral background.



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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