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.

New Product Introduction Engineer

This position provides outstanding customer service to Impel’s drug-device 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 New Product Introduction Engineer transitions products from design to manufacturing and leads the technical coordination, development, and review of manufacturing related activities using semi-automated and automated manufacturing equipment. This role 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 New Product Introduction Engineer delivers high quality processes and products to program deadlines.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.

  • Owns technical manufacturing development within Impel’s project team
  • Oversees tool qualification and process validation at suppliers worldwide
  • 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 sustaining engineer, leading the resolution of product issues during early product manufacture.
  • 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
  • Other projects as assigned

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Bachelor’s degree is required, degree in Mechanical Engineering preferred.
  • Minimum 3 years of experience as a Mechanical or Manufacturing Engineer fast paced, multi-project, technical manufacturing environment
  • Must be proficient in Microsoft Office products, Proficiency with Microsoft Project or Smartsheet is a plus.
  • Must have an understanding of tool qualification, process validation, process control and FDA 21 CFR 820 manufacturing requirements.
  • Must be dedicated to continuous learning and have a desire to take on an ever-changing list of tasks.
  • Experienced in working in a matrix cross functional, highly collaborative product development team
  • Travel – up to 25%
Logistics Manager

This position provides outstanding, accurate, timely logistical support to the Engineering, Operations, Life Sciences and Formulation teams.  The ideal hands-on candidate is detail oriented, timeline driven, has a positive attitude, is flexible, organized, multi-tasks, can deal with ever changing priorities, and enjoys learning new ways to support ever faster team execution, capability and company growth.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. All duties and responsibilities apply in support of Engineering, Operations, Life Sciences, and Formulation departments. Other duties may be assigned.

  • Manages and maintains collective inventory for all GMP manufacturing for clinical and commercial product
    • Ensures adequate component inventory for device manufacture
    • Ensures adequate clinical inventory, including device and drug
    • Ensures adequate commercial inventory, including device and drug
  • Manages and maintains clinical and commercial forecasting, production planning and purchasing for GMP manufacturing
  • Executes global logistics, product packaging for shipment, and material movements, using temperature controlled containers and couriers as needed
  • Tracks and executes international clinical distribution for early stage clinical studies
  • Manages the operational bill of materials within Impel and communication of that BOM and changes to suppliers
  • Interacts with project teams to ensure supplies are provided in time to achieve key performance indicators.
  • Manages material actions related to design and process change within Impel and at suppliers
  • Manages budget for inventory, materials and shipping within the Operations function.
  • Manages and maintains import/export brokerage relationships and process
  • Tracks and maintains storage at third party warehouses
  • Publishes metrics and yield for assembly operations
  • Assists in developing logistics relationships, plans and procedures

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Bachelor’s degree is required
  • Minimum 5 years of experience as a Logistics Coordinator, Analyst, or Specialist, in a fast paced, progressive biotech or other regulated environment
  • Must be proficient in Microsoft Office and Visio, Proficiency with Microsoft Project or Smartsheet is a plus.
  • Direct knowledge of import/export regulation as it pertains to FDA regulated products is highly preferred
  • Travel – up to 25%
Director of Business Development

The Director of Business Development will lead ongoing and new business activities that result in licensing, partnering or acquisition of internal and/or external assets. This position will act as a strategic leader and thought partner to Impel’s leadership team and will drive key business partnerships and opportunities.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
• Drive all aspects of business development efforts, including strategic partner identification, partnering, in-licensing, out-licensing and related contracting activities.
• Develop and manage relationships across a network of potential partners particularly small and large biopharmaceutical companies in the neuroscience industry
• Develop and maintain Impel’s knowledge on the interests of potential partners and competitive activities
• Coordinate evaluation of new opportunities including market and financial analyses.
• Assist in negotiation of terms and formulation of proposed offers for transaction under evaluation.
• Interact on a daily basis with cross-functional stakeholders in support of execution of ongoing transaction/development of final contracts.
• Serve as one of the company’s ambassadors to the market as a representative at industry conferences.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
• Bachelor’s degree with 7-10 years’ experience in biotech/pharma business development.
• Experience in new business development activities, including customer interaction, acquisition and procurement processes, competitive assessment, and strategic planning.
• Excellent analytical skills, including familiarity with financial modeling.
• Outstanding communication skills (interpersonal, verbal and written).
• Strong leadership skills.
• Exceptional project and customer management skills.
• Excellent teamwork and collaboration skills.
• Travel expectation: 30-50%.

Director of Marketing

The Director of Marketing will be the first full time marketing hire at Impel and will initially have broad responsibility for commercial development of Impel’s pipeline of products. This includes the development and implementation of Impel’s commercial strategies for existing drug-device candidates including: market landscape and assessment (using primary and secondary data sources), TPP development, marketing and market research plan (pre-commercialization and launch), branding and messaging. It may also include assessing the commercial value of future drug-device candidates as opportunities arise. As the company quickly grows and changes with emerging clinical data over the next year, the role will evolve and may become more focused based on the needs of the company and interests of the Director.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Develop and execute brand strategies and brand plans including market assessment, competitive landscape review, TPP development, product positioning, promotional messaging, and multichannel marketing.
• Plans, directs, and executes all marketing strategies, functions, policies, objectives and initiatives.
• Maintain clear vision of product marketplace, focusing on new product potential, competitive developments, shift in treatment paradigm and opportunities.
• Responsible for reimbursement, access and pricing strategies and development of pricing models by segment.
• Develop appropriate marketing and advertising support (pre-commercialization and launch) for product markets including marketing communication materials, tradeshows, website, etc.
• Work with Business Development (BD) to provide input during due diligence activities that include market and competitive insights, forecasting and ROI.
• Plan and develop company marketing and communications materials. To include print media, video, webinars and other training media.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
• Bachelor’s degree in Marketing, Business or life sciences required. MBA is preferred.
• 7-10 years of marketing and commercial experience in the pharmaceutical/medical device/life sciences industry.
• Experience with marketed and pipeline products, high growth companies, neuroscience and/or drug/device combinations ideal.
• Strong analytical skills and a working knowledge of business finance, pricing and forecasting.
• Deep understanding of the pharmaceutical value chain and drivers in the pharmaceutical business (Payors, Physician and Patient).
• Demonstrated high level of integrity and business ethics.
• Excellent verbal and written communication skills.
• Ability to manage multiple conflicting priorities.
• Travel expectation: 20-40%.

Sr. Specialist/Manager, 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. The position (title) offered will be dependent on the level of experience.

ESSENTIAL DUTIES AND 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 regulatory templates (i.e. StartingPoint), 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 and/or lead the promotion of electronic initiatives in the company in support of with electronic submissions

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Bachelor’s Degree or higher in a relevant field
  • 5+ years of direct, hands-on 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
  • Competency in MS Project, MS Visio applications and XML and SQL specifications is preferred

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