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.

HR Manager

This position is responsible for providing leadership and establishing and implementing HR strategy for Impel. This will include recruitment, talent and leadership development, discipline and termination, salary and benefits administration, new hire orientation, and the development of personnel policies and procedures.

RESPONSIBILITIES include the following. Other duties may be assigned.

  • Identify and help lead HR efforts to ensure all HR initiatives, program, processes and policies are communicated and implemented effectively
  • Manage recruiting process including posting jobs, reviewing and selecting resumes, interviews and reference checks
  • Manage onboarding process of new hires
  • Serve as link between management and employees by handling questions, interpreting and helping to resolve work-related problems
  • Assist with employee relations including complaints, investigations, performance concerns, and terminations
  • Provide benefits plan design and plan administration (enrollment, broker/vendor management)
  • Manage performance appraisals, making program recommendations where appropriate.
  • Ensures compliance with applicable state and federal laws (OFCCP, COBRA, ERISA, ADA, etc.)
  • Other duties as assigned

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Bachelor’s degree required, HR focus preferred
  • Minimum 5 years of progressive responsibly and experience in an HR department, Life Sciences or Biotech company desired.
  • Ability to develop HR programs and policies based on business requirements
  • Knowledge of all aspects of HR management, principles and procedures for recruitment, diversity & inclusion, training, compensation and benefits, employee relations
  • Advanced knowledge of employment and compliance laws
  • Proficient skills in Microsoft Office and Visio. Proficiency with Microsoft Project is a plus
  • Excellent communication and networking skills
Manager/Sr Manager – Nonclinical Outsourcing

Responsibilities include the following.  Other duties may be assigned.

  • Lead scientific, technical, and business-related risk assessments to assist in CRO selection and evaluations, including leading and managing the Request for Proposal process
  • Perform CRO on-site assessments of CROs for pharmacokinetics, toxicology, safety pharmacology, and developmental and reproductive toxicity studies
  • Design, supervise, analyze, interpret, and report in vivo non-GLP and GLP studies conducted at CROs including PK, toxicology and safety pharmacology studies in collaboration with study monitors and other scientists. Ensure appropriate quality of documentation and record keeping are compatible with global regulatory submission requirements.
  • Work collaboratively with CROs and internally across-disciplines to coordinate study timelines and deliverables
  • Accountable for critical documents including study protocols, reports, nonclinical sections of regulatory documents. May contribute to manuscripts and regulatory submissions.
  • Candidate should have strong critical thinking and research skills and a desire to conduct early development /mechanistic studies as well as GLP-compliant IND enabling toxicity studies.
  • Develop and maintain cross-departmental collaborations and shared work practices across functional groups and participate in project teams.
  • Contribute to departmental processes such as SOPs and templates.

Qualifications

  • Ph.D. in Pharmacokinetics/Pharmacology/ Toxicology/ Biological Sciences or related discipline with 2+ years of biotech, pharmaceutical industry or CRO experience; MS +5 years experience or BS with +8 years experience.
  • Demonstrated comprehensive knowledge of designing, conducting and interpreting nonclinical PK, PD and toxicology studies.
  • Strong knowledge of nonclinical drug development, FDA and ICH guidances, and GLP regulations.
  • Direct experience working on multidisciplinary drug development project teams and comprehensive knowledge of drug development strategy.
  • Outstanding organization and planning skills, and the ability to multi-task and understand project team deliverables.
  • Proficient at critically reading and applying relevant scientific literature.
  • Excellent analytical and soft skills to interact effectively and harmoniously with vendors and stakeholders.
  • Proven ability to thrive in a collaborative team environment: strong oral and written communication skills, and a helpful team spirit.
  • Demonstrates a sense of urgency, proactive and creative thinking, and productivity in a fast-paced, innovative and team-oriented environment.
  • Travel required up to 30% per year to monitor outsourced studies (domestic and international.)
Principal Scientist – Analytical Development and Outsourcing

As a member of the Analytical Sciences team, this role will support early and late stage 505(b)(2) small molecule drug development programs at Impel. Specifically, the individual will lead all outsourced analytical chemistry efforts on designated projects in alignment with the cross-functional development team. The ability to develop novel and creative solutions to overcome project obstacles and make significant conceptual contributions to project teams are critical for success.

Responsibilities include the following.  Other duties may be assigned.

  • Serve as the lead scientific and technical expert to assist in evaluations of GMP testing facilities, including leading and managing Request for Proposal process for the Analytical Sciences group
  • Perform on-site assessments of CROs for GMP testing capabilities of drug substance, drug product and drug-device combination products
  • Guide testing laboratories to develop, validate and transfer analytical methods suitable for progressive stages of pharmaceutical development
  • Work with internal Analytical Sciences team to leverage in-house capabilities to reduce time and cost spent on outsourced development and non-GMP activities
  • Design validation protocols that are in compliance with ICH and FDA guidelines, and identify critical factors that may not be mandated by the guidelines but are essential for validating the methods for their intended use
  • Together with the CMC cross-functional team, set and justify drug substance and drug product specifications with the understanding of clinical study design and CMC processes
  • Justify and set retest period, storage, and shipping conditions
  • Understand chemical development, solid state development, and formulation development to identify and document critical factors that impact method performance and/or analytical development activities
  • Work alongside Drug Development & Manufacturing team to identify critical in-process-control issues and develop appropriate IPC methods
  • Design, oversee, analyze and interpret stability study results for drug substance and drug product
  • Timely monitor and evaluate release and stability data from CMOs and CROs for GMP compliance, potential out of specification, out of trend, and method performance issues and supervise or conduct investigations and implement corrective actions as needed
  • Present to cross-functional teams and effectively communicate critical analytical issues and solutions
  • Develop, review, and approve source documents for regulatory submissions

Qualifications

  • Ph.D. in Analytical Chemistry, Organic Chemistry or related field with 5+ years of relevant analytical development experience; MS with 8-10+ years of experience; supervisory experience a plus
  • Broad understanding of the drug development process, including clinical design, toxicology, regulatory filings, chemical development, solid state development, and formulation development, and the interrelationship with analytical development is essential
  • Demonstrated knowledge of ICH, FDA, and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development
  • Skilled in HPLC, LC-MS, GC, GC-MS, FT-IR, UV-VIS, KF, NMR, and broad knowledge of other techniques used in pharmaceutical analysis; experience with nasal spray or MDI/DPI product testing a plus
  • Outstanding organization and planning skills, and the ability to multi-task and understand project team deliverables
  • Proficient at critically reading and applying relevant scientific literature
  • Excellent analytical and soft skills to interact effectively and harmoniously with vendors and stakeholders
  • Proven ability to thrive in a collaborative team environment: strong oral and written communication skills, and a helpful team spirit
  • Demonstrated leadership skills, a sense of urgency, proactive and creative thinking, and productivity in a fast-paced, innovative and team-oriented environment
  • Travel up to 30% (domestic and international)
Director, Clinical Quality Assurance

ACCOUNTABILITY OBJECTIVE:

The primary responsibility for this position will be managing/directing the Clinical QA activities to support GCP and Clinical Trial obligations.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

    • Meet the ongoing needs of the quality assurance department by maintaining CQA compliance for ongoing and planned clinical trials.
    • Lead investigations and write CAPAs on GCP issues as they arise.
    • Ensure proper maintenance of the Quality systems.
    • Directly interface with Clinical Operations to provide support for vendor, site, and internal GCP audits.
    • Work with clinical operations and regulatory affairs to review IND and NDA submission documents.
    • Responsible for ensuring submission data and documentation meets GCP guidelines.
    • Perform and/or support audits of clinical sites, CROs and other clinical vendors.
    • Assist in authoring clinical operation SOPs and processes as needed.
    • Develop and support established records management procedures.
    • Provide input and change management for quality improvements affecting CQA systems.
    • Assist with writing and editing documents needed for the clinical quality management system.
    • Update and maintain CQA SOPs that support the quality systems.
    • Manage and update electronic libraries.
    • Facilitate meetings with CRO’s and other clinical entities as appropriate.
    • Ensure Trial Master Files are maintained within standards.
    • Other duties as assumed or assigned.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

    • Bachelor’s degree
    • Education and experience in an FDA-regulated environment.
    • Ten (10) years of related quality or clinical experience in a similar environment.
    • Broad knowledge of clinical processes and procedures, electronic documentation systems, and Good Clinical Practices 21CFR Parts 50, 56, and 312.
    • Demonstrates initiative and proactively provides collaborative support to the clinical teams.
    • Ability to plan and organize work in an efficient manner and work well under time constraints.
    • Demonstrates effectiveness in maintaining CQA control systems for compliance with FDA regulations.
    • Must have experience using MS Office
    • Experience in MasterControl or a similar ECM system is a plus.
    • Willing to travel 20-30%.

PHYSICAL DEMANDS

This is a fast-paced environment with moderate noise level. Limited travel may be required.

WORKING CONDITIONS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines

Research Technician (Contract)

ACCOUNTABILITY OBJECTIVE:

The laboratory technician will support the Analytical Sciences function of the Life Science group through basic testing support and laboratory maintenance.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Prepare samples for testing and buffers/solutions by following procedures with high fidelity
  • Assist and perform laboratory testing, including pH, capsule filling, loss on drying, drug-device compatibility tests, assisting in the preparation and execution of stability studies, and HPLC testing and analysis
  • Record experiments in detail in laboratory notebook
  • Inventory supplies weekly, update Hazardous Materials Inventory weekly, and place orders as needed
  • Support Analytical Sciences team through washing dishware, daily checks/weekly calibration of balances, daily pH meter calibration, and helping to maintain a clean and tidy work area
  • Proactive attitude to provide helping hands to all laboratory team members

 

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Bachelor’s degree in Chemistry, Analytical Chemistry, or the life sciences required
  • 0-2 years of laboratory experience required, industry or academic, inclusive of college coursework with laboratory requirements
  • Exceptionally organized, self-starter, and the ability to prioritize work for timely completion
  • Highly motivated learner, eager to fulfill all requirements of this position and the desire to continue to learn
  • Effective communication skills, both verbally and in writing
  • Ability to understand complex instructions and carry out procedures complying with 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

 

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

 

Long periods of standing may be required to complete the demands of the position.

 

Must be able to lift 30 lbs.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines.

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level. No travel required.

Pharmacometrician/PK Scientist - Modeling and Simulation

ACCOUNTABILITY OBJECTIVE:

The PK Scientist – Modeling & Simulation will be a key team member of the Translational Sciences team and will work closely with the Regulatory and Clinical Operations teams. This individual will independently and creatively use modeling and simulation tools to enhance quantitative decision making. The modeling and simulation activities include non-clinical and clinical modeling and simulation, including but not limited to, population PK/PD models, translational models, clinical trial simulations, literature meta-analysis, and other innovative, state-of-the-art modeling and simulation techniques.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Excellent understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation
  • In depth, hands-on knowledge and experience with modeling and simulation software and applications in the area of PKPD modeling, simulation and statistics (Phoenix WinNonlin, Phoenix NLME, NONMEM or comparable applications)
  • Lead all modeling and simulation efforts at Impel and bring a solid understanding of the principles of pharmacokinetics (non-compartmental, compartmental, PBPK) and biopharmaceutics to the team
  • Build on solid foundation of quantitative skills to develop mechanistically-relevant PK-PD models
  • Drive to the understanding of the covariates that contribute to variability in PK and/or PD
  • Translate/condense/summarize outcomes of modeling and simulation analyses into information that can be used by project teams, presented internally or externally
  • Support comparative BA and BE clinical study design through PK modeling and statistical assessments
  • Conduct clinical trial simulations
  • Conduct simulations to characterize PK/PD in special populations (pediatrics) and translational models
  • Contribute to pre-INDs, INDs, NDAs and work closely with the Regulatory team on submissions

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Ph.D. in pharmacokinetics, pharmaceutical sciences, pharmacology, biostatistics or similar disciplines where modeling and simulation is emphasized
  • 5+ years of industrial experience in practical applications of modeling and simulation is required
  • Independent, self-starter, positive attitude
  • Creative problem-solver and ability to efficiently and effectively implement models at Impel
  • Highly organize and outstanding written and oral communication skills
  • Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of PK-PD modeling and simulation
  • Advanced understanding of the global drug development process and collaborations among multiple functions from discovery to commercialization

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines.

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level.

Up to 10% travel may be required.

Senior Administrative Assistant (Contract)

This position will provide outstanding customer service and administrative function to the Engineering, Operations, Clinical, Analytical and Translational Sciences Teams.  The ideal candidate must have a positive attitude, extreme flexibility and adaptability, excellent organizational skills, ability to deal with ever-changing priorities, and enjoy 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES includes the following. All duties and responsibilities apply in support of Engineering, Operations, Clinical, Analytical and Translational 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, Analytical and Translational 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
  • Other duties as assigned

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • High School Diploma. Bachelor’s degree is highly desired
  • 5 plus years of experience as an Administrative Assistant in a fast-paced, progressive environment
  • Life Sciences/Biotech experience is highly desired
  • Must be proficient in Microsoft Office, Excel 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.

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