Join Impel

Impel NeuroPharma is a clinical stage pharmaceutical company based in Seattle, WA. We are committed to developing the next generation of central nervous system (CNS) drug treatments. Impel’s proprietary Precision Olfactory Delivery (POD) technology enables many categories of therapeutics, including biologics, to be delivered to the CNS using cost-effective, disposable, and non-invasive intranasal drug delivery devices. We are working hard to develop meaningful treatments for devastating CNS diseases, and we hope you’ll join us.

Product Development Engineer

Job Description

As a Product Development Engineer, you will work with Impel’s worldwide supply base for components, device assembly and testing services to achieve project success.  You will develop specifications, test methods, protocols, execute testing, analyze results, and create final reports consistent with good documentation practices to meet regulatory requirements for our combination products. You will provide sustaining engineering support for devices molded and assembled at contract manufacturers.

Characteristics

You must have excellent cross functional team communication skills and outstanding documentation skills to be successful in this role. You work well within a team, and execute and achieve milestones to plan.  You are a self-starter, motivated to develop products on aggressive timelines.  You are organized, and live up to your commitments.  You demonstrate perseverance in solving problems.  You are passionate about making a difference to patients by successfully developing new therapies.

Typical Responsibilities may include:

  • Define product specifications to meet clinical performance and regulatory requirements.
  • Design and execute statistically based R&D experiments for product development
  • Develop test methods and design, develop, and create tooling to meet R&R requirements in support of Design Verification and Validation
  • Mange verification and validation protocols and reports; verify and validate device designs to both clinical and commercial timelines, including the use of pharmaceutical formulations in the evaluation of device performance
  • Manage third party testing laboratories to project requirements and timeline
  • Manage third party suppliers of components to project requirements and timeline; manage process validation within the supply chain
  • Ensure that applicable projects are in compliance with GxP, QSR (including Design Controls), ISO or other applicable requirements
  • Provide sustaining engineering support for molded parts and devices manufactured at third party suppliers for clinical and commercial production
  • Participate in FDA inspections, Customer Audits, and Supplier Audits as necessary
  • Support Quality Assurance and Regulatory Affairs by providing needed information and contributing to quality management system
  • Other projects as assigned

 

 

 

Qualifications:

  • Bachelor’s degree in Engineering with 2+ years relevant industry experience, preferably in a cGMP/FDA regulated environment
  • Hands-on experience with test equipment and metrology instruments; mechanical aptitude required
  • Experience working with commercial products
  • Detail oriented team player with effective planning, organization, and execution skills
  • Excellent verbal and written communication skills required, including adherence to formalized document control
  • Ability to adapt and respond to the needs of a growing organization conducting both R&D and commercialization activities
  • Versatility to engage with various functional representatives and contribute impromptu/ad hoc in the entrepreneurial spirit
  • Ability to work effectively at a fast pace with cross-functional teams
  • Please be proactive, resourceful, and self-motivated

Optional but desired:

 

  • Machine shop experience
  • Minitab experience
  • Solidworks experience
  • Experience managing outside manufacturing suppliers
  • Injection molding experience
  • Product assembly experience
  • Knowledge or experience with a formalized engineering or design document change process
  • Experience working within Design Controls regulation

 

Travel:

Travel may be required up to 25% of the time.

Accountant

The Staff Accountant will provide support to the accounting and administrative functions of the company.  This is a full time job with focus on transaction recording and reporting.

Job Description:

  • Understand, enforce, and contribute to accounting policy
  • Account Reconciliation
  • Inventory and Fixed Asset Tracking
  • A/P and A/R
  • Track outbound shipments
  • Receive inbound shipments
  • Month end tasks as assigned
  • Prepare responses to ad-hoc queries as requested
  • Other tasks as assigned

Qualifications:

  • Bachelor’s degree in Accounting. Candidates from other disciplines with good accounting skills may be considered
  • Knowledge of GAAP
  • 0-2 years of experience is appropriate for the position
  • Ability to adapt and respond to the needs of a growing organization conducting R&D project activities. Interpersonal and negotiation skills are emphasized
  • Versatility to engage with various functional representatives, and contribute impromptu/ad hoc in the entrepreneurial spirit
  • Familiarity with Microsoft Office Suite and Internet based office applications
Senior Quality Assurance Specialist

Impel NeuroPharma is an emerging medical device company developing novel drug delivery devices that enables drugs to bypass the blood-brain barrier (BBB) using direct nose-to-brain delivery. Impel’s proprietary Precision Olfactory Delivery (POD) technology enables many categories of therapeutics, including biologics, to be delivered to the central nervous system using cost-effective, disposable, and non-invasive intranasal drug delivery devices.

Job Description:

  • Assist in developing and maintaining aspects of the Impel NeuroPharma Quality Management System including writing and reviewing SOPs and other controlled documentation
  • Review supplier material specifications
  • Conduct supplier manufacturing batch record review
  • Conduct timely batch failure investigations
  • Resolve quality issues and routine deviations
  • Track outstanding CAPAs to completion
  • Conduct quality audits
  • Track audit observation responses
  • Review supplier validation protocol and reports
  • Measure, analyze, and trend quality
  • Conduct quality training
  • Provide leadership for improving the quality of product and product-related processes

 

Qualifications:

  • Experience with batch record review and working knowledge of lot release
  • Ability to work well in a project team environment
  • Experience in medical device or drug manufacturing
  • Ability to author, review, and approve SOPs and other controlled documentation for compliance with applicable regulations
  • Bachelor degree or the equivalent
  • 5-7 years’ experience working in Quality Assurance in the medical device or drug industry
  • Working knowledge in the application of FDA regulations and ICH guidelines covering good manufacturing practices in the development and manufacturing.
  • Good verbal and written communication skills
  • Should be familiar with Microsoft Word, Excel, and PowerPoint
  • Please be proactive, resourceful, and self-motivated

 

Regulatory Affairs Project Manager

Job Title:         Regulatory Affairs Project Manager

Impel NeuroPharma is an emerging medical device company developing novel drug delivery devices that enable drugs to bypass the blood-brain barrier (BBB) using direct nose-to-brain delivery. Impel’s proprietary Precision Olfactory Delivery (POD) technology enables many categories of therapeutics, including biologics, to be delivered to the central nervous system using cost-effective, disposable, and non-invasive intranasal drug delivery devices.

Job Description:

  • Review new regulations for implications for the company and recommend strategy to achieve compliance with requirements
  • Work with multiple cross functional departments to coordinate information required by regulatory consulting strategists across numerous projects
  • Manage consulting firms responsible for delivering regulatory projects on behalf of the company
  • Ensure consulting invoices are accurate and comply with contracts in place; be prepared to vouch for results and analyze budget to actual as necessary
  • Summarize project results and recommendations for management
  • Ensure execution of cross functional deliverables is provided timely and accurately
  • Compile and edit regulatory documents with various internal contributors
  • Assist in preparation of information to be submitted to outside regulatory strategists
  • Other tasks as assigned

Qualifications:

  • Science degree required
  • 2-5 years experience in a highly regulated environment
  • 1 or more years engaged in vendor management
  • Strong interpersonal skills with demonstrated performance in cross functional project leadership positions
  • Demonstrated leadership of effective project team meetings, reviews, and activities
  • Be highly organized and familiar with document version control
  • Familiarity with Microsoft Office Suite and Internet based office applications
HR Generalist III

This is Impel NeuroPharma’s first HR employee.  This employee is expected to support the HR needs of all other departments.  There is great opportunity for the right candidate to gain experience in building systems from the ground up.

Job Description:

  • Leads all day-to-day HR activities
  • Address investigations promptly and in a professional manner
  • Proactively reviews HR programs and policies
  • Maintain employee records according to State and Federal requirements
  • Ensure compliance with local, state, and federal employment laws
  • Coordinate and conduct all recruiting efforts
  • Coordinate and conduct onboarding activities
  • Process benefit enrollments, changes, and terminations
  • Serve as employee advocate for escalated benefit questions
  • Document and maintain processes, procedures, and employee handbook
  • Support annual Open Enrollment process
  • Other tasks as assigned

Qualifications:

  • Bachelor’s degree in Business, Human Resources, or related discipline
  • Knowledge of state and federal employment laws
  • 5+ years of HR experience required
  • Ability to adapt and respond to the needs of a growing organization conducting R&D project activities. Interpersonal and negotiation skills are emphasized
  • Versatility to engage with various functional representatives, and contribute impromptu/ad hoc in the entrepreneurial spirit
  • Familiarity with Microsoft Office Suite and Internet based office applications
Product Development Engineer III

Job Title:            Product Development Engineer III

_______________________________________________________________________________

 

Impel NeuroPharma is an emerging medical device company developing novel drug delivery devices that enables drugs to bypass the blood-brain barrier (BBB) using direct nose-to-brain delivery. Impel’s proprietary Precision Olfactory Delivery (POD) technology enables many categories of therapeutics, including biologics, to be delivered to the central nervous system using cost-effective, disposable, and non-invasive intranasal drug delivery devices.

 

Job Description

The Product Development Engineer is responsible for technical execution of projects and product development.  This role will support the matrix based product development team through compliant product development and actively lead and participate all activities within the multi-stage gate development process.  The Product Development Engineer will function across the organization in technical matters or issues challenging the business.

 

Primary Responsibilities:

 

  • Develop injection molded mechanical designs that fulfill system requirements
  • Develop product specifications and test methods for both in-house use and tech transfer to other facilities
  • Develop test methods and related documentation to support Design Verification and Validation.
  • Design, develop, and fabricate test fixtures.and tooling to support Design Verification and Validation
  • Evaluate and resolve product technical product performance issues
  • Apply statistical methods throughout the Verification and Validation process
  • Analyze test data using relevant data analysis methods to support design decisions
  • Verify and validate device designs for both clinical and commercial milestones, including the use of clinical stage pharmaceuticals in the evaluation of device performance
  • Manage verification and validation protocols and test reports, creation through release
  • Manage 3rd party testing laboratories where applicable
  • Design and execute statistically based R&D experiments for product development
  • Review validation and testing protocols for Impel’s supply chain
  • Provide Engineering support for design related manufacturing issues
  • Other projects as assigned

 

Qualifications

 

  • Bachelor’s degree in Mechanical Engineering or equivalent field.
  • Knowledge of applying statistics toward experimental design, sampling strategy, and process control
  • Excellent verbal and written communication skills required, including adherence to formalized document control
  • Experience designing plastic parts and assemblies using CAD (Solidworks native)
  • Hands-on experience with test equipment and metrology instruments; mechanical aptitude required

 

 

Characteristics:

 

  • Must be proactive, resourceful, self-starting and self-motivated
  • Detail oriented team player with effective planning, organization, and execution skills
  • Ability to adapt and respond to the needs of a growing organization conducting both R&D and commercialization activities
  • Versatility to engage with various functional representatives and contribute impromptu/ad hoc in the entrepreneurial spirit
  • Ability to work effectively at a fast pace with cross-functional teams

 

Optional but desired:

 

  • Machine shop experience (small shop onsite)
  • Experience managing outside manufacturing vendors
  • Knowledge or experience with a formalized engineering or design document change process
  • Experience working within Design Controls regulation

 

 

Travel:

 

  • Some travel required (up to 25%).
Manufacturing Engineer

Impel NeuroPharma is an emerging medical device company developing novel drug delivery devices that enables drugs to bypass the blood-brain barrier (BBB) using direct nose-to-brain delivery. Impel’s proprietary Precision Olfactory Delivery (POD) technology enables many categories of therapeutics, including biologics, to be delivered to the central nervous system using cost-effective, disposable, and non-invasive intranasal drug delivery devices.

Job Description:

  • Lead sustaining engineering support for device manufacturing through in-house testing and on-site support at Contract Manufacturing Organizations (domestic and international).
  • Participate in the transfer from Product Development to Manufacturing, including process validation support and functional testing.
  • Participate in product commercialization, while maintaining compliance with GxP, QSR (including Design Controls), ISO or other applicable requirements
  • Provide hands on trouble shooting, debugging, and investigation for manufacturing issues.
  • Update engineering models and drawings using CAD while adhering to EDMS.
  • Design and execute statistically based testing protocols for product testing.
  • Analyze test data using relevant data analysis to support design decisions, including statistical methods.
  • Review validation and testing protocols of components and assemblies.
  • Manage 3rd party service providers and suppliers where applicable.
  • Support QA/QC and Regulatory Affairs by providing needed information and contributing to quality management system.
  • Support product development to facilitate smooth transition of product ownership to manufacturing.
  • Other projects as assigned

 

Qualifications:

  • Bachelor’s degree in Mechanical Engineering or other applicable engineering discipline
  • Strong working knowledge of manual & automated assembly; process test & inspection.
  • Understand equipment validation, calibration, correlation, capability, repeatability & reproducibility.
  • 5-10 years relevant industry experience.
  • Working knowledge of designing products with CAD (preferably SolidWorks).
  • Hands-on experience with test equipment and metrology instruments; mechanical aptitude required
  • Advanced knowledge of applying statistics toward experimental design, sampling strategy, and process control
  • Experience working with commercial products and supporting regulatory inspections
  • Detail oriented team player with effective planning, organization, and execution skills
  • Excellent verbal and written communication skills required, including adherence to formalized document control
  • Ability to adapt and respond to the needs of a growing organization conducting both R&D and commercialization activities
  • Versatility to engage with various functional representatives and contribute impromptu/ad hoc in the entrepreneurial spirit
  • Ability to work effectively at a fast pace with cross-functional teams
  • Demonstrated interest in the life science industry
  • Please be proactive, resourceful, and self-motivated

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