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TITLE

 

PRINCIPAL SCIENTIST – ANALYTICAL DEVELOPMENT AND OUTSOURCING

COMPANY

 

Impel NeuroPharma

LOCATION

 

Seattle, WA, US

Description

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)

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