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.

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 & 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)
Senior Director, Commercial Manufacturing/Operations

As the Senior Director, Commercial Manufacturing/Operations you will:

  • direct and manage the global manufacture and supply of clinical and commercial products to achieve business objectives
  • be accountable for the execution and effectiveness of clinical and commercial demand planning and S&OP process
  • operate at the highest levels of decision making related to combination product manufacture and supply.

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Lead the collective manufacture and supply for all Impel clinical and commercial products including:
  • Clinical demand planning and supply for global studies
  • Commercial forecasting, demand planning and management of commercial drug and device supplies
  • Management of the commercial supply chain, including device component suppliers and assemblers, drug manufacturers, co-packaging suppliers, and serialization and distribution of product
  • Develops departmental structure, function, and personnel to deliver upon necessary departmental and company Key Performance Indicators.
  • Accountable for developing and executing an S&OP process
  • Assess and communicate risk and opportunity related to the global supply of clinical and commercial product
  • Oversee global logistics and material movements
  • Participate on product development teams to ensure supplies are provided in time to achieve key performance indicators
  • Interacts and aligns department function with Impel’s New Product Introduction teams
  • Develops and manages annual departmental budgets for inventory, materials, and logistics within the Operations/Supply Chain function
  • Oversee import/export brokerage relationships and process
  • Establish and oversee third party logistics firm(s) for distribution and fulfillment of Impel’s commercial products
  • Works with Quality Assurance to ensure Supplier Quality requirements are achieved and maintained.
  • Develops and publishes metrics to communicate and manage the effectiveness of the Operations function and the global supply chain leading to increased efficiency, cost reduction and improved customer service.
  • Identifies areas for improved efficiency and drives cost reduction for commercial programs through appropriate means.
  • Interacts with Finance to ensure alignment of product costing within the ERP system.
  • Travel up to 30% is anticipated.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • Seven years’ experience in medical device, pharmaceutical or biotech company is required
  • Bachelor’s degree in Business, Finance, Logistics or Engineering is required. Minimum 10 years of related Operations and Supply Chain experience in a fast paced, progressive biotech, medical device or other regulated environment is required.
  • Experience in the successful management of supply for both clinical and commercial supply of pharmaceuticals, medical devices or combination products is required.
  • Experience in the successful management of CMO relationships is required.
  • Ability to develop, coach and guide a leadership team in the execution, development of strategies leading to the achievement of company Key Performance Indicators is required.
  • In-depth, direct experience with the implementation and use of commercially available ERP systems is required. Knowledge of demand planning and the S&OP process is required.
  • Must be proficient in Microsoft Office and Visio.
  • Proven experience in developing and nurturing relationships with critical manufacturing partner is required.
  • The ability to collaborate and partner across all levels of the organization and Supply Chain is required.
  • Demonstrated experience with best practices related to Commercial Manufacturing/Operations

EDUCATION, EXPERIENCE AND/OR SKILLS PREFERRED

  • Direct knowledge of import/export regulation as it pertains to FDA regulated products is highly preferred
  • Combination Product experience is highly preferred
  • An advanced technical degree or MBA is preferred
  • Proficiency with Microsoft Project or Smartsheet is preferred

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