Associate Director, Functional Biocharacterization and Impurities

Evotec•Redmond, WA

1d•$154,000 - $180,000•Onsite

About The Position

We’re looking for a passionate and curious Associate Director, FBI who is an enthusiastic and hardworking leader that is passionate about expanding worldwide access to biotherapeutics through the advancement of analytical sciences focused on functional, biochemical, binding, and related assay technologies. This position will oversee early and/or late-phase functional method development for novel and biosimilar products, and will include technology transfer to Quality Control as well as technical support for other functions to ensure success of all functional methods. In addition, the position will drive advancement of our functional methods and capabilities. The ideal candidate will have strong scientific group management and leadership skills as well as a proven track record of a deep understanding of functional methods for clinical and commercial therapeutic proteins. Additionally, the ideal candidate is curious, creative, engaged, and the type who works well independently and in teams while constantly looking for ways to advance scientific processes and improve technology. As an Associate Director at Just-Evotec, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

Requirements

BS/MS in Chemistry, Biochemistry, Biology, or related field with 15+ years of experience in the pharmaceutical industry or Ph.D. in Chemistry, Biochemistry, Biology, or related field with 9+ years of experience in the pharmaceutical industry.
Deep subject matter expertise in functional, biochemical, binding, and related assay technologies, technology development, transfer to QC, and authoring of CMC sections of regulatory filings.
Experience with analytical development supporting late stage products and/or biosimilars.
Experience in leading a high functioning analytical sciences team for late stage projects and collaborations as well as technology development initiatives.

Nice To Haves

Experience analyzing data in tools such as JMP, R, or Python.
Expertise in design of experiments (DOE) and statistical analysis.
Knowledge of cGMP and quality and/or regulatory requirements in the US and/or EU.

Responsibilities

Lead a diverse group of scientists responsible for all aspects of functional, binding, and impurity method development for all stages of product development.
Develop, implement, and continuously improve analytical development strategies aligned with company goals and client needs to accelerate development timelines and reduce costs while providing excellent client services.
Lead complex projects and investigations, integrating deep knowledge of functional method development and broad CMC knowledge of project work with knowledge of multiple functional areas outside of analytical sciences.
Maintain a focus on phase-appropriate quality and an eye to delivering for client needs.
Drive technology development strategies to enhance analytical offerings to support process intensification and continuous manufacturing to reduce manufacturing costs and footprint through improvements in productivity, product quality control, and data management through collaboration with vendors, internal and external partners as well as influencing the biologics industry.
If possible, develop analytical offerings that differentiate Just from its competitors.
Serve as an internal technical resource and subject matter expert for external clients and partners.
Author CMC regulatory sections as required.
Effectively model leadership behaviors in line with Evotec corporate culture and foster a culture of scientific excellence, collaboration, and continuous improvement.
Clearly and effectively communicate scientific information, experimental plans, data and strategies to internal project teams, cross-functional area teams, senior management, external clients, vendors, and technology development collaborators as well as the external scientific community such as regulatory agencies, review boards, publications, and conferences.
Manage staff, training, capital resources, and planning within the department while supporting multiple client and technology projects at various stages of development.