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 consistent and predictable intranasal drug delivery devices. We are working hard to create life-changing, innovative therapies for CNS diseases and we hope you’ll join us.

Administrative Assistant, Engineering

The Administrative Assistant will provide outstanding customer service and administrative function to the Engineering, Operations, Clinical and Life Sciences Teams.  The ideal candidate must have a positive attitude, extreme flexible, organized, multi-tasks, able to deal with ever changing priorities, and enjoys learning new ways to support faster team execution and capability.

Though reporting to the SVP of Engineering, this position will have a dotted line relationship to the Heads of Clinical and Life Sciences.

Responsibilities include the following.  All duties and responsibilities apply in support of Engineering, Operations, Clinical and Life Sciences departments. Other duties may be assigned.

  • Management and planning support: calendars, meetings, department organization, travel and expense reports
  • Coordination of purchasing and receipt activities
  • Administrative support to the Heads of Engineering/Operations, Clinical and Life Sciences, and others, as assigned
  • Partner with other Administrative functions within Impel to manage shipments, deliveries in addition to providing overall company support as necessary
  • Departmental budget tracking for expenses and purchases
  • General departmental organization on Dropbox
  • Management of visitors

Qualifications

  • High School Diploma. Bachelor’s degree is highly desired
  • Minimum 3 years of experience as an Administrative Assistant in a fast paced, progressive environment
  • Must be proficient in Microsoft Office and Visio. Proficiency with Microsoft Project or Smartsheet is a plus.
  • Must be capable of continuous learning and have a desire to take on an ever changing list of tasks.

Qualified candidates, please email your resumes to hr@impelneuropharma.com

Lab Assistant

The laboratory assistant will support the analytical sciences function of the Life Science group through basic testing support and laboratory maintenance.

 

Responsibilities include the following. Other duties may be assigned.

  • Inventory supplies weekly and place orders as needed
  • Prepare samples for testing and buffers/solutions
  • Assist and perform laboratory testing, including pH, capsule filling, loss on drying and drug-device compatibility tests
  • Clean and maintain work area
  • Other duties as assigned

 

Qualifications

  • High school / GED required, college degree and/or some coursework in the sciences a plus
  • 2+ years of laboratory experience required
  • Organized and the ability to prioritize work for timely completion
  • Effective communication skills, both verbally and in writing
  • Ability to understand complex instructions
  • Able and willing to maintain strict level of confidentiality regarding laboratory results and records
  • Ability to record and tabulate data; meticulous record keeping in the laboratory notebook

Qualified candidates, please email your resumes to hr@impelneuropharma.com

Clinical Trial Associate

The Clinical Trial Associate will provide support for all clinical activities, ensuring the successful completion of clinical trials.

Responsibilities include the following. Other duties may be assigned.

  • Track and manage CRFs, queries and clinical data flow. May act as central contact for the clinical team for designated project communication, correspondence and associated documentation
  • Prepare, handle and distribute Clinical Trial supplies and maintenance of tracking information
  • Participate in team meetings and generate meeting agendas and minutes
  • Assist with the entry and tracking of data/samples in clinical databases and other associated data tracking tools
  • Maintain databases for appropriate study administration
  • Prepare and perform periodic review of the TMF including all GCP-related documents
  • Administer all study and related documents (correspondence, monitoring reports, contact reports, and other organizational documents) before and during the study
  • Coordinate with external vendors and sites
  • Generated/Track Check Requests for Investigator, Vendor Payments, and Pass Thru Payments based on the requests received by PM and/or Clinical Operations Manager

Qualifications

  • Bachelor’s Degree or higher in a relevant field
  • 1-2 years of experience in pharmaceutical industry or CRO
  • Experience supporting clinical trials
  • Basic knowledge of drug development and FDA GCP regulatory guidelines
  • Excellent oral and written communication, with particular attention to detail
  • Excellent organizational and problem-solving skills
  • Proven ability to learn and adapt in an evolving work environment
  • Advanced-level proficiency with MS Word, Excel, and Adobe Acrobat
  • Familiarity with MS project, MS Visio applications is preferred

Qualified candidates, please email your resumes to hr@impelneuropharma.com.

Clinical Research Associate

We are seeking an experienced in-house Clinical Research Associate (CRA) to join our growing Clinical Operations department. This is a mainly in-house position, although some limited site visiting will be required, offering competitive pay, and career development potential.

As the in-house CRA, you will be responsible for leading and assisting with clinical operations activities for various CNS studies. This position offers a unique opportunity to work on outsourced clinical trials and also participate in clinical operations oversight as Impel continues to grow and bring more functional responsibility internally.

Responsibilities include the following. Other duties may be assigned.

  • Manage defined aspects of clinical trials to ensure trials follow SOPs, FDA regulations and ICH/GCP guidelines
  • Assist clinical study sites and contracted CROs with start-up activities including IRB submissions and review of required essential study documents
  • Develop or assist contracted CROs in preparation of study documents (e.g., study plans, site training materials, lab manuals, methodologies, site tools, worksheets, study trackers)
  • Assist CROs in the development of eCRFs and eCRF completion guidelines (eCCGs).
  • Review completed eCRFs or data listings for accuracy, oversee data discrepancy management by the CROs and perform associated trainings/re-trainings as needed
  • Perform ongoing review of (electronic) Trial Master File (eTMF) held by CROs to ensure files are maintained in compliance with GCP, FDA, and ICH guidelines and prepare for transfer to Impel
  • Facilitate information flow between clinical trial sites, clinical project team members, other members of the Clinical Operations team (including CRO) and other staff as appropriate.
  • Assist in vendor (including CRO) selection and oversight
  • Represent Clinical Operations in project team meetings with CRO and internally
  • Draft and coordinate review of informed consent forms (ICFs)
  • Review and provide constructive feedback on study monitoring reports and follow up letters
  • Provide support to the monitoring team, and may assist in conducting pre-study, site initiation, interim monitoring and close out visits if requested (field visits ~ 1x/month)
  • Assist in management of investigational products (drug/device) and ancillary equipment supply.
  • Perform remote monitoring of clinical studies and alert Impel Clinical Operations team and CMO to any concerns/issues noted
  • Participate in investigator and vendor meetings
  • Manage internal and external study team members
  • Ability to adapt to a fast-paced, quickly changing environment and able to prioritize duties in alignment with company goals

Qualifications

  • Bachelor’s degree or equivalent in a scientific discipline
  • Minimum five years of experience in Clinical Operations
  • Previous experience as field-based CRA preferred
  • Previous Good Clinical Practice (GCP) training
  • Experience generating clinical documents
  • Strong familiarity and competence with Word, Excel, PowerPoint required
  • Excellent oral and written communication and interpersonal skills
  • Excellent organizational skills and attention to detail
  • Advanced-level proficiency with MS Word, Excel, and Adobe Acrobat
  • Familiarity with MS project, MS Visio applications is preferred
  • May require up to 25% travel

Qualified candidates, please email your resumes to hr@impelneuropharma.com.

Intellectual Property Paralegal

The Intellectual Property (IP) Paralegal will work closely with the Chief Scientific Officer and provide support for patent preparation, filing, patent searches, and patent maintenance for patent applications filed based on research activities at Impel NeuroPharma. The IP Paralegal will also provide support in trademark prosecution, copyright registration, domain registrations, and general contracts management.

Responsibilities include the following. Other duties may be assigned.

  • Work with outside IP firm to coordinate all aspects of IP, Trademark, Copyright work at Impel
  • Coordinate and perform patent and legal research as required
  • Summarize legal documents for the various members of Impel management
  • Analyze documents for accuracy
  • Prepare drafts of legal documents
  • Prepare legal correspondence and declarations
  • Disseminate, track, and retrieve required legal documents necessary for patent and trademark prosecution and copyright registration
  • Analyze and track intellectual property in coordination with outside IP firm
  • Provide support in the preparation and filing of selected patent applications for both U.S. and international patent applications
  • Coordination of all IP assets for projects under management (copyright, patent; trademark, domain.), including support for internal patent searches
  • Administrative support for other contract work at Impel, including related database entry
  • Additional administrative responsibilities as assigned

Qualifications

  • Bachelor’s degree or equivalent combination of education and experience
  • Two years of complex Patent Prosecution or Legal Administrative work experience or related work experience
  • Proven organizational, administrative, interpersonal, problem-solving and decision-making skills
  • Proven ability to exercise independent judgment, multi-task and meet required deadlines
  • Proven ability to work well with diverse personalities in a team, and function well under pressure
  • Strong working knowledge of Microsoft Office products
  • Flexibility and availability for some local and national travel

Qualified candidates, please email your resumes to hr@impelneuropharma.com.

Senior Manufacturing Engineer

The Senior Manufacturing Engineer provides outstanding customer service to Impel’s combination product development programs by ensuring timely and technically rigorous implementation of new designs into manufacture at Impel’s Contract Manufacturing Organization(s) (CMO). The Sr Manufacturing Engineer leads the technical coordination, development, and review of manufacturing related activities. This role is responsible for the manufacturing technical transfer of design into clinical and commercial manufacture, with specific focus on injection molding and semi-automated and automated assembly lines.  This role oversees, manages, and ensures technical rigor of tool qualification and process validation at Impel’s worldwide supply base.

 

The ideal candidate has a positive attitude, is flexible, organized, multi-tasks, can deal with ever-changing priorities and enjoys learning new ways to create ever faster team execution and capability.  The Sr Manufacturing Engineer delivers high-quality processes and products to program deadlines.

 

Responsibilities include the following. Other duties may be assigned.

  • Owns technical manufacturing development within Impel’s project team
  • Manages tool qualification and process validation at suppliers worldwide
  • Evaluates technical capability and contributes to the CMO selection
  • Develops Impel’s manufacturing capacity to support manufacture of Impel product, clinical through
  • Supports Operations by participating in the planning, maintenance, and development of new, modified and/or existing manufacturing activities conducted at
  • Acts as point of contact for manufacturing related
  • Participates on technical teams for Impel’s virtual manufacturing operations.
  • Maintains adherence to medical device quality standards and regulations, with emphasis on CMC
  • Leads internal and external team efforts to resolve manufacturing issues through application of experience, technical knowledge and
  • Works closely with the Quality Assurance group to ensure that manufacturing operations at Impel’s CMOs are in control.
  • Identifies and mitigates risks associated with manufacturing processes
  • Keep key stakeholders apprised of impending manufacturing activities and challenges
  • Up to 25% travel is anticipated
  • Other projects as assigned

 

Qualifications

  • Bachelor’s degree is required.
  • Minimum 5 years of experience as a Manufacturing Engineer, Assembly Process Engineer, and/or Plastics Tooling Engineer in a fast-paced, multi-project, progressive environment
  • Must be proficient in Microsoft Office products, Proficiency with Microsoft Project or Smartsheet is a plus.
  • Must have a thorough grasp of tool qualification, process validation, process control and FDA 21 CFR 820 manufacturing requirements.
  • Must be capable of continuous learning and have a desire to take on an ever-changing list of tasks.
  • Experienced in working on a matrix cross-functional, highly collaborative product development team

Qualified candidates, please email your resumes to hr@impelneuropharma.com.

Senior Specialist, Regulatory Operations

This position will be responsible for managing and executing moderately complex submission, compilation and publishing activities associated with electronic submissions and for providing subject matter expertise in eCTD implementation.

Responsibilities include the following. Other duties may be assigned.

  • Prepare and/or oversee the preparation of high quality regulatory submissions for multiple programs/products in development (e.g. IND, CTA, NDA, BLA) with a focus on eCTD.
  • Manage the review of regulatory submission documents for completeness and quality in accordance with regulatory agency requirements and standards
  • Manage projects with vendors and contractors to meet schedules and ensure quality
  • Serve as the Regulatory Operations lead, collaborating with Regulatory Affairs and the cross-functional project team to develop and implement submission strategies and timelines.
  • Provide functional and technical guidance with respect to submission of clinical trial applications and marketing applications
  • Manage and maintain regulatory information including relevant logs, trackers and archives of regulatory submissions, correspondence and commitments.
  • Manage and maintain regulatory document templates and regulatory style guide
  • Develop applicable SOPs and/or other written practices relating to the regulatory affairs operations function
  • Develop and provide training on the use of templates, processes and tools critical to compiling electronic submissions (i.e., software, authoring templates and publishing tools)
  • Advise and direct evaluation, selection, and implementation of technology and equipment related to submission planning, preparation, assembly, dispatch and/or archiving
  • Assist in the leadership and promotion of electronic initiatives in the company in support of with electronic submissions

Qualifications

  • Bachelor’s Degree or higher in a relevant field
  • 5-8 years of experience with regulatory submission and project coordination
  • 5 years of experience with processes and standards, regulatory technology (including publishing software) and document management is required.
  • Good knowledge of drug development, FDA, and eCTD regulatory guidelines with Working knowledge/understanding of biologics and/or small molecule product development, including CMC, pre-clinical, and/or clinical development
  • Excellent oral and written communication, with particular attention to detail
  • Excellent organizational and problem-solving skills
  • Proven ability to learn and adapt in an evolving work environment
  • Advanced-level proficiency with MS Word, Excel, and Adobe Acrobat
  • Familiarity with MS project, MS Visio applications and XML and SQL specifications is preferred

Qualified candidates, please email your resumes to hr@impelneuropharma.com.

Senior Quality Assurance Specialist

The Quality Assurance Specialist is a crucial role in conducting all aspects of Quality Assurance within the Impel NeuroPharma GXP operations. This position will ensure GXP compliance both internally and external to the organization with contracted service providers. The Sr. QA Specialist is responsible for managing, coordinating, facilitating and implementing quality assurance standards based on ICH, European and FDA requirements across all Impel NeuroPharma products. This position will write quality assurance SOPs and policies, develop and control early-stage quality programs, monitor suppliers/CRO conformance with QA standards and procedures and set their direction for regulatory compliance.

Responsibilities include the following. Other duties may be assigned.

  • Act as liaison with US regulations during product development and commercial supply
  • Serve as the primary quality assurance resource for problem identification, resolution, and continuous improvement.
  • Track, coordinate and participate as necessary in qualification or audit process of suppliers
  • Maintain collection and analysis systems of statistical data to predict trends that will affect improvement of product quality
  • Report to management on quality issues and trends
  • Author, edit, revise, approve SOPs, POLs, and forms as directed or needed
  • Obtain all documentation necessary for qualification of suppliers
  • Review API and drug product specifications
  • Perform supplier’s master batch record review
  • Perform supplier’s executed batch record review and approval
  • Review in-house and supplier’s deviations, CAPAs, change controls and perform root cause analysis
  • Participate in risk assessments
  • Approximately 10% travel required

Qualifications

  • Bachelor’s degree required
  • 5+ years’ experience in Quality department
  • Strong technical writing ability
  • Strong organizational skills, task-oriented, excellent time management skills
  • Ability to multi-task; flexible and adaptable to changing priorities
  • Works well with limited supervision and as a team member
  • Effective communicator who demonstrate the ability to negotiate assigned tasks with staff
  • Proficient in Microsoft Office Suite (e.g., Outlook, Word, Excel, PowerPoint)

Qualified candidates, please email your resumes to hr@impelneuropharma.com.

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