Head, Analytical Development

Location
Redwood City, CA
Posted
Apr 18, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
This role reports directly to the CTO and will lead Analytical Development to advance ADVM-022 and pipeline products, setting our analytical development strategy and making decisions that will define the current and future analytical methods.  The Incumbent is responsible for outlining and communicating the Company’s AD vision: implementing and leading critical analytical development strategies and ensuring that the scientific and technological resources are aligned with the Company’s business and regulatory needs.   
 
In this role, the ED AD works closely with the executive leadership to define the commercial analytical methods for both Process Development and Quality Control to pave the path to BLA submission and licensure of ADVM-022.  This will include ensuring that development, qualification and validation, and transfer activities are planned and executed to support late stage development and licensure of gene therapies. The incumbent is responsible for ensuring AD resources are used efficiently, effectively, compliantly, and securely.
 
This role requires excellent leadership skills, strategic thinking, strong business acumen, and in depth knowledge of AAV analytical development. This Incumbent is expected to be experienced with designing commercial analytical methods, and well-versed in current AAV analytical development trends and to be familiar with business concepts that can be applied in a fast-moving technology arena at the cutting edge of gene therapy.
What you'll do:
  • Collaborate closely with Technical Development, Quality Control and Regulatory to understand internal customer requirements and define and execute strategic plan to support
  • Provide leadership and guidance to the Analytical Development team – ensure the team is staffed, structured, resourced and supported to deliver methods according to the overall analytical strategic plan
  • Develop and execute a comprehensive strategy to develop analytical characterization methods to support late-stage development and licensure
  • Identify and establish partnerships with external vendors as needed to provide analytical development activities that can be outsourced
  • Represent analytical development to LT, Board, and external stakeholders, preparing materials and presenting as needed
  • Act as subject matter expert (SME) for the analytical methods in drafting, reviewing, and overall supporting regulatory interactions and documentation

About you:
  • Ph.D. in biochemistry, molecular biology, or appropriate technical discipline with 10+ years (MS with 14+ years) of industrial analytical development experience
  • Experience working with AAV-based vector technologies, developing development analytical methods, commercial methods and characterization methods
  • At least 10 years of management experience, with at least 5 years’ experience leading an analytical development team
  • Highly motivated to lead by example and exceed expectations in all aspects of the role
  • Extensive knowledge of late-stage analytical development activities supporting process characterization, process validation and licensure application is required
  • Broad experience and understanding of regulatory guidelines
  • Demonstrated the ability to lead and to function in a collaborative/team oriented CMC environment
  • Ability to communicate effectively and connect with all levels of the organization
  • Strong project leadership and resource management skills
  • Require excellent written/oral communication
  •  
  • PERSONAL CHARACTERISTICS & CULTURAL FIT:
  • Outstanding written and oral communication skills.
  • Impressive executive presence and engaging personality, with ability to interface professionally with key stakeholders, Board of Director and investors.
  • Team builder with a highly collaborative leadership style; ability to build / lead cohesive, high performing program teams.
  • Self-starter with a passion to achieve results with proven ability to generate high quality, on-time results.
  • Creative with strategic problem-solving skills.
  • Strong multi-tasking and prioritization skills.
  • Comfortable working in highly entrepreneurial environment.

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation