Sr. Scientist, DrugDevice Combo Pdts

Job Description

Job Description

Our Companys Device Development & Technology (DD&T) Team is seeking a hands-on/ lab-focused engineer focused on the characterization and testing of devices (components sub-assemblies and full devices) and combination products (drug-delivery products). This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our Companys pipeline to identify risks (i.e. when/why/how will the device fail) and opportunities for improvement. They will utilize a wide variety of cutting-edge analytical instruments methods and extensive data analysis/interpretation to build fundamental understanding of the devices material and functional properties and attributes. Many of the drug delivery device technology platforms are often assemblages of injection molded plastic components driving delivery of a drug typically though mechanical (i.e. compress/torsion spring compressed gas) or electro-mechanical (i.e. DC motor and battery driving a gearbox) means. Examples include but not limited to injector pens on-body injectors and inhalers. At this early stage of evaluation material is often limited and will demand creative approaches.

Our Company is on a quest for cures and is committed to being the worlds premier most research-intensive biopharmaceutical company. Today were doubling down on this goal. Our Companys Research Laboratories is a true scientific research facility of tomorrow and will take our Companys leading discovery capabilities and world-class small molecule biologics and vaccine R&D expertise to create breakthrough science that radically changes the way we approach disease treatment.

Join us and experience our culture first-hand one of strong ethics & integrity diversified experiences exceptional science and a resounding passion for improving human health. As part of our global team youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Education Requirement (minimum):

• B.S. M.S. or Ph.D. in Mechanical Engineering or equivalent field is required.

Required Experience and Skills:

• A minimum of a Ph.D. M.S. plus 4 years or B.S. plus 6 years of design engineering and mechanical testing/test method development experience.

• Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting.

• Experience training junior staff on instrumentation operation and data analysis/interpretation best practices.

• Deep technical understanding of test method development and qualification/validation/transfer techniques.

• Fluency with mechanical testing imaging and measurement equipment and techniques. Including but not limited to force/tension/compression testing rhinometry and microscopy.

• Excellent collaboration ideation and prototyping skills including fixture development for functional testing.

• Experience in 3D CAD (e.g. Solidworks) geometric tolerancing and stack-up analysis.

• Documents (following Good Documentation Practices) and analyzes test cases and provides comprehensive feedback and recommendations for product or design changes.

Preferred Experience and Skills:

• Experience operating and interpreting data from Instron XRCT Microscopes Vision Systems (ex Keyence / Cognex) Bouncer and drop shape analyzers.

• Develop innovative mechanical tests with validations including engineering studies design verification protocols stability studies and validation protocols ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSAs) for all finished product performance test methods as needed in tech transfer or lifecycle.

• Experience with medical device development with understanding of Design Controls (21 CFR 820.30)

• Familiarity with the following standards: Quality Management ISO 13485 Risk Management ISO 14971 EU MDR Medical Electrical Equipment EN 60601 Medical Device Software Standard IEC 62304 ISO 11608 Needle-based injection system for medical use.

• Additional familiarity/experience with the following industry related knowledge is a plus:

  • 21 CFR Part 4

  • 21 CFR 211

  • FDA Guidance for Industry Container Closure Systems for Packaging Human Drugs & Biologics

  • ISO 13485

  • ISO 14971

  • ISO 11040

  • ISO 10993

  • ISO 11608

Required Skills:

Preferred Skills:

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U.S. Hybrid Work Model

Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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