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Director, Analytical Development Jobs

Company

Icosavax
Address , Remote
Employment type
Salary $175,000 - $215,000 a year
Expires 2023-11-29
Posted at 8 months ago
Job Description
Apply
Icosavax, Inc. (NASDAQ: ICVX) is a publicly traded biopharmaceutical company leveraging its innovative VLP platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases. Icosavax’s VLP platform technology is designed to enable multivalent, particle-based display of complex viral antigens, which it believes will induce broad, robust, and durable protection against the specific viruses targeted. Based in Seattle, Icosavax was formed in 2017 to advance the breakthrough VLP technology from the Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases.
The Director, Analytical Development will collaborate across all disciplines within Icosavax to progress vaccine candidates including early and late-stage CMC development.
JOB DUTIES:
  • Accountable for technical review and approval of internal and external analytical development documentation.
  • Collaborate with all external labs, overseeing method implementation and data generation, in support of clinical and tox material supply.
  • Collaborate closely with QC to ensure analytical methods are phase-appropriate and that qualification/validation is robust; actively participate in the specification setting process for our intermediates, drug substances, and drug products.
  • Collaborate with R&D and Translational Sciences in order to develop and implement strategies for the development of assays & methods for testing, release, and characterization of our vaccine candidates from early through late-stage development and into commercial; provide expert guidance on the development of analytics for the evaluation of the potency and stability of vaccine candidates, ensuring fit for purpose, robust assays are in place and in use.
  • Deliver analytical characterization packages for vaccine candidates (drug substance and drug product), including adjuvant-containing drug products, across the development lifecycle.
  • Provide analytical development technical expertise and oversight to internal and external collaborators (e.g. CDMO) to ensure strategies and tactics are appropriate, effective, and aligned with Icosavax strategy.
  • Support overall CMC platform development and delivery of GMP material by participating on cross-functional teams responsible for delivering clinical trial material in a time and cost-effective manner aligned with Icosavax strategy.
  • Lead effective technical discussions, risk assessments, investigations, etc. driving cross functional teams to consensus.
  • Make critical decisions and trade-offs that improve resource utilization and ensure program success while maintaining an appropriate risk profile.
  • Deliver CMC sections for CTD documents.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
  • PhD in chemistry, biochemistry, or closely related field, or equivalent experience applicable to the job responsibilities
  • PhD with 8 years of related experience or master’s with 12 years of related experience or bachelor’s with 15 years of related experience.
  • 10+ years Biologics and analytical development experience required; strong preference for recombinant protein vaccine experience, especially VLP-based antigens and adjuvant-based formulation systems.
  • Deep experience with structural characterization of complex proteins in support of regulatory filings and aligned with the principles of well characterized biological products.
  • Proven ability to function in multidisciplinary cross functional team environments using clear communication and matrix management skills.
  • Industry experience that includes transition of early-stage QC methods to late-stage programs including preparation of regulatory filings.
  • Deep understanding of GMP, CFR, and ICH Guidelines, specifically how they apply to analytics for biologics.
  • Excellent self-management, organizational, and verbal/written communication skills.
  • Experience with vaccine development and interactions with the Essential Regulatory Laboratories, desired
PHYSICAL DEMANDS:
  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
OTHER:
  • Location: Remote/USA
  • Must be eligible to work in the USA
  • To reduce the presence and severity of COVID-19 cases in the workplace and in our communities, Icosavax requires all newly hired employees to be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state and local law.
  • The salary range for this position is $175,000 – $215,000; the base salary will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered health insurance (medical, dental, vision), health savings account with company contribution, flexible spending account, life insurance, short- and long-term disability, employee stock purchase plan, 401(K) plan with company contribution, vacation, sick and safe time, company holidays and floating holidays.