Job Title: Sr. Director - CMC

Reports To (Title): SVP, Technical Operations

Function: CMC

Written By: C. Richardson

Date Written: August 2019

Effective Date: 

 

OBJECTIVES: 

  1. Manage the technology transfer of process methods, procedures and analytical testing from internal discovery and research collaborators to CMO or other manufacturing partners for company vaccine components and products.

  2. Oversee the manufacturing processes and operations for clinical and commercial production of bulk drug substance (i.e. recombinant protein production) and final drug products both internally and at CMO locations to assure compliance with GMP, ICH Guidelines, and all applicable regulations.

  3. To effectively direct the development, implementation, and maintenance of process methods and equipment for the production of process formulas, technologies, and products to achieve cost effectiveness and improved product quality.

  4. To plan and implement in cooperation with vendors and partners the development of new process formulas, operating equipment specifications, and improved manufacturing techniques as required.

ACCOUNTABILITIES: 

  1. Responsible for sourcing of appropriate CROs/CMOs and directing the development, transfer, and validation of unit processes, including fermentation, recovery, and downstream purification for the company’s biologic bulk drug substances, intermediates and final vaccine products.

  2. Responsible for directing development of multiple analytic assays for release, stability, and characterization of company’s vaccine components and products.

  3. Responsible for overseeing collection and interpretation of data for biomarker and biological characterization assays, including cell-based, multiplexed protein assays, polymerase chain reaction, and flow cytometry methods.

  4. Responsible for directing development of biochemical assays for lead validation and optimization for disease-related targets.

  5. Responsible for providing 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.

  6. Responsible for the manufacture of clinical and commercial production of bulk drug components (i.e. recombinant protein production) and final vaccine products both internally and at CMO locations in compliance with GMP, ICH Guidelines and all applicable regulations.

  7. Other duties as needed.

 

 

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

  • PhD in chemistry, biochemistry, or closely related field, or equivalent experience applicable to the job responsibilities

  • Biologics and analytical development experience required; strong preference for recombinant vaccine experience.

  • Track record of success required, including effectively leading and managing multi-functional groups including multiple CMOs/CROs.

  • 7-10 years of significant applicable industry experience including proof of concept in CMC development through manufacture of product. Preference for late stage manufacturing experience.

  • Expertise in GMP, CFR, and ICH Guidelines

  • Excellent self-management, organizational, and verbal/written communication skills.

  • Demonstrated proficiency in Data handling, analysis, and presentation both verbal and written including Excel and PowerPoint

 

PHYSICAL DEMANDS: 

 

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).   

 

TRAVEL REQUIREMENTS:

 

  • Preferred location is Seattle Washington, USA.

  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.

  • Requires approximately 20% travel.

Icosavax, Inc.

2815 Eastlake Ave E, Suite 300

Seattle, WA 98102

  • White Twitter Icon
  • White Facebook Icon
  • White LinkedIn Icon
SEND US A MESSAGE

© 2019 Icosavax, Inc. All rights reserved.