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R&D Associate II/Associate Scientist I - Process Engineering & Packaging - BPD

Location Gaithersburg, Maryland, United States Job ID R-076281 Date posted 03/03/2020

1) Pilot Laboratory Operation: Contribute to the operation of a fill-finish pilot laboratory with lab scale capabilities including vial and syringe filling, lyophilization, and device assembly.  The candidate will work on cross-functional teams to ensure equipment/process capability for process development studies on multiple pipeline projects. Perform risk assessments, design experimental protocols and write reports.  Provide technical rigor in experimental design and data analysis across projects.  Test, analyze and interpret a range of protein and peptide characterization assays (e.g. HPLC, UPLC, HIAC, MFI, cIEF). 

2) Process Characterization: Conduct experiments in development laboratories or manufacturing sites to characterize processes in support of clinical and commercial tech transfers.  These studies will be conducted to establish design space of fill-finish unit operations and set the manufacturing control strategy. Regulatory writing responsibilities include supporting clinical and commercial filings.  Carry out ongoing academic, regulatory and vendor literature review, maintain cutting edge technical knowledge, and communicate findings to team.  

3) Tech Transfer: Assist clinical-stage and commercial technical transfer of fill-finish and device assembly processes to CMOs and internal manufacturing facilities for biopharmaceutical drug products. Support engineering and clinical fills at GMP fill-finish sites. Provide on-site support of fills, provide support to investigations.  Sound technical writing skills and interpersonal communication are required.  Some travel is required (typically 0-5 trips per year) in the US and abroad. 

Minimum Education Requirements:

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

R&D Associate II: Bachelors degree with 2+ years of experience OR Master's degree with 0+ years of experience.

Associate Scientist I: Bachelors degree with 5+ years of experience OR Masters degree with 2+ years of experience.

Required Skills:

The candidate should have capability, skill and/or knowledge in several 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:

  • University laboratory research, pharmaceutical R&D internships or full-time positions, or similar. 
  • A high degree of self-motivation and technical rigor is required. 
  • Strong communication and technical writing skills are essential. 
  • Experience participating in 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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