Device Assembly Process Engineer (Associate Scientist I/II) - BPD

Gaithersburg, Maryland

Posted in Pharmaceuticals
about 2 months ago

This job has expired.

Job Info

This position can be filled at either the Associate Scientist I or Associate Scientist II level. The candidate will support assembly process development for medical devices and/or combination products, which may include accessorized prefilled syringes, auto-injectors, and/or other devices.

Primary responsibilities will include:

1) Device/Combination Product Assembly Technical Leadership: Contribute to the operation of a fill-finish/assembly pilot laboratory with lab scale capabilities including vial and syringe filling, lyophilization, and device assembly. Develop risk assessment tools, study protocols and report templates. 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

2) Assembly Process Characterization: Perform risk analyses and conduct laboratory or engineering studies to characterize processes. Test, analyze and interpret a range of assembly methods on device or combination product performance (e.g. injection time, glide force). Design process steps, establish associated operational design space and control strategy. Support engineering and Clinical/Commercial GMP runs at assembly sites. Review and approve batch records, validation protocols, and other GMP documents. Provide on-site support for assembly activities and support to close non-conformances. Support Regulatory writing for clinical and commercial filings.

3) Medical Device/Combination Product Design Transfer: Assist or lead late-stage and commercial design transfer of assembly processes to CMOs and internal facilities for parenteral biopharmaceutical or synthetic drug products (including technical support for clinical technology transfer as required). Organize 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 DT 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 Mechanical Engineering, Biomedical or related engineering or pharmaceutical science field.

Associate Scientist I: Bachelors degree and 5+ years OR Master's degree and 2+ years of experience.

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

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

  • Biopharmaceutical / combination drug product development
  • Combination product and cGMP regulations
  • Assembly, label and packaging processes and equipment
  • Validation of Equipment, Process and Shipping Configurations
  • QbD, experimental design, statistics, data analysis
  • Leadership and interpersonal communication
  • Technical writing and documentation


Suitable experience may include development of combination products and/or associated manufacturing processes, Quality oversight or validation of device/combination product assembly processes. Design Transfer experience or experience organizing and leading cross-functional teams is valuable. Knowledge of injection molding and materials science of polymers is beneficial. A high degree of self-motivation, mechanical skill and technical rigor is required. Strong communication and technical writing skills are essential. Though this position is in Development, we will consider strong candidates with GMP process development experience, e.g. in technical services or validation. We will also consider strong candidates from a device development or small molecule parenteral background.

This job has expired.
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