Director, Translational CMC

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SUMMARY: Icosavax, Inc., a member of the AstraZeneca Group (LSE/STO/Nasdaq: AZN), is a biopharmaceutical company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform. 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. Icosavax’s pipeline includes vaccine candidates targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). Based in Seattle, Icosavax was formed in 2017 to advance the breakthrough VLP technology with the goal to discover, develop, and commercialize vaccines against infectious diseases. In 2024, AstraZeneca acquired Icosavax, Inc. AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.
Icosavax seeks a Director, Translational CMC with a strong background in large molecule process development and analytical development to advance our vaccine programs. The primary focus of this position will be to lead the Seattle-based CMC lab function which includes CHO cell culture manufacturing, protein purification, and biophysical characterization. The role will provide direct oversite of the lab-based team and technical expertise regarding processes and analytics. The successful candidate will be an experienced scientific and people leader, with recombinant protein technologies, cGMP manufacturing, and clinical development experience. This position will report directly to the SVP, Technical Operations.  
JOB DUTIES
·       Provide oversight to the lab-based Seattle team, including mentoring, coaching, and development.
·       Accountable for technical support and troubleshooting of Icosavax’s VLP platform and associated analytics, both internally and with key CDMOs.
·       Oversee CHO cell line development and optimization of recombinant protein expression using a variety of production formats.
·       Oversee purification and formulation development for recombinant proteins and virus-like particles.
·       Develop analytical strategies to characterize the key structural and functional attributes of new antigen candidates.
·       Transition new antigen candidates into CMC development for the purposes of enabling early phase human clinical trials.
·       Develop manufacturing processes using scale down models for generation of Toxicology material and transfer to CDMOs for early-stage clinical manufacturing.
·       Support overall CMC development and delivery of GMP material by participating on cross-functional teams responsible for risk assessments, process characterization, and process validation.
·       Provide technical CMC expertise and oversight to research, development, and program management personnel both internally and with collaborators/CMO to ensure processes and designs are appropriate and effective.
·       Enable partnering and collaboration across all Seattle-based lab functions.
·       Author and/or review and approve regulatory filings as needed.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 
·       Ph.D. degree in chemistry, biochemistry, or related field, or equivalent experience applicable.
·       8+ years of relevant industry experience including CMC development, GMP manufacturing, regulatory writing, and clinical development and 4+ years of supervisory experience.
·       Biologics and analytical development experience required; strong preference for experience with recombinant proteins and vaccines experience, especially VLP-based antigens.
·       Proven ability to lead a scientific function and drive delivery in multidisciplinary teams.
·       Working knowledge of GMP, CFR, and ICH Guidelines.
·       Excellent organizational and verbal/written communication skills
·       Ability to work autonomously, take smart risk-based decisions, and couch and mentor talent.
·       Demonstrated proficiency in data analysis and ability to use data to drive risk-based decision making.
PHYSICAL DEMANDS: 
·       Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).   
OTHER:
·       Location: Seattle, WA
·       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 $190,000 – $230,000 per year; 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, 401(K) plan with company contribution, vacation, sick and safe time, company holidays and floating holidays.

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