Sr Quality Control SpecialistApply
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. Icosavax’s pipeline includes vaccine candidates targeting respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 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.
Icosavax seeks to hire a Sr Quality Control Specialist with biotech vaccine experience for our Quality Team. This position will play a key role in managing the reference standard and critical reagent programs for early and late-stage vaccine development. The successful candidate will interface with key Icosavax functional and cross-functional teams, as well as our CDMO/CRO partners for vaccine development.
The successful candidate will be highly self-motivated, productive, a quick learner, and creative. They will be comfortable partnering with Icosavax’s CMC, Clinical and Nonclinical teams to manage procurement, inventory and performance of critical reagents and reference standards in support of all Icosavax’s candidate vaccine programs. In addition, the candidate will be comfortable partnering manufacturing and testing activities with CDMO and CTL partners. Successful candidates will have excellent problem-solving skills as well as strong written and verbal communication skills.
This position requires an independent strategic thinker motivated by performance excellence and team success, someone who can roll up their sleeves and assist where needed, work within an evolving matrixed organization, support lean operations teams, and partner with employees at all levels of the organization. The successful candidate will be a positive and enthusiastic team player motivated by performance excellence and team success with the ability to collaborate across the organization and anticipate program needs. They will take pride in the quality and timely delivery of their work.
Collaborate with clinical, non-clinical and CMC teams to plan and maintain supply of critical reagents and reference standards for vaccine candidate programs.
Coordinate manufacturing and release of critical reagents through CDMO/CTL.
Oversee inventory, storage, reagent performance trending and bridging activities for all critical reagents and reference standards.
Generate appropriate reports and documentation [i.e., trend reports and lot bridging reports] in support of critical reagent and reference standard programs.
Perform laboratory duties as required in support of critical reagent and reference standard programs [i.e., aliquoting, labelling, testing support].
Coordinate delivery of critical reagents and reference standards to cross-functional teams and CDMO/CTLs as required to support clinical and manufacturing activities.
Support general QC function including data review and stability program support for Icosavax vaccine candidate programs.
B.S. in chemistry, biochemistry, or closely related field, or equivalent experience applicable to the job responsibilities.
5+ years of applicable QC and cross-functional experience including in a startup environment.
Experience administering reference standard and critical reagent programs in a GMP environment preferred.
Familiarity with relevant characterization and release methods [SEC, CE-SDS, Biolayer Interferometry, ELISA, DSC, DLS, etc.]
Familiarity with US and EU GMP regulations, and ICH Guidelines.
Excellent self-management, organizational, and verbal/written communication skills.
Experience working as part of multidisciplinary cross functional team.
Effectively represent the Quality organization both internally and externally.
Experience with electronic quality management systems preferred.
Proficiency with standard project management, virtual communication, and cloud-based documentation tools.
Manual dexterity required to operate office and laboratory equipment.
Location: Seattle, WA
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.
Must be eligible to work in the USA.
The salary range for this position is $82,000 – $105,000 per year; the base salary will be determined based on knowledge, skills, education, experience relevant to the role and location. This role is also eligible for bonus and equity compensation. 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.