Director, Analytical Sciences

Just-Evotec Biologics is looking for a Director of Analytical Sciences to join a fast-paced, collaborative, and multidisciplinary team to lead all aspects of analytical sciences for the advancement of low-cost biotherapeutics manufacturing.

The Director is responsible for strategic oversight and leadership of the full scope of analytical activities supporting novel biologics and biosimilar products from pre-clinical through commercialization. These activities include state-of-the-art analytical characterization, method development, qualification/validation and transfers, authoring and reviewing regulatory submissions, development of analytical comparability and similarity assessment strategy for biosimilars, analytical control strategies for continuous manufacturing, QC support, and close collaboration with other functions such as process development, drug product development, manufacturing, and quality.

This role requires a deep understanding of analytics for therapeutic proteins including a strong technical background in separation sciences, immunoassays, biological characterization, and mass spectrometry. A proven track record of technical skills in these areas, strong management and leadership skills, a working knowledge of CMC manufacturing, and experience with early and late stage regulatory filings and regulatory interactions is essential.

Responsibilities

• Lead a diverse group of experienced scientists encompassing all aspects of analytical sciences for novel biologics and biosimilars
• Optimize strategies for method development, qualification/validation and transfer, analytical characterization, and biosimilarity assessment.
• Lead efforts to identify, evaluate and champion new analytical technologies to support the mission of low cost biotherapeutics for all
• Collaborate across the organization and be a key member and contributor to the Process Design Leadership Team
• Be a technical resource on analytics for novel biologics and biosimilars for Discovery, Process Design, Quality, and Manufacturing, as well as a resource and subject matter expert for clients, service providers and collaborators.
• Serve as an analytical development lead and/or oversee leads on cross-functional project teams.
• Partner with Quality to ensure compliance with regulations for late stage development 
• Manage and develop staff, and manage capital and resource planning
• Develop and refine analytical strategies that incorporate best practices and regulatory expectations
• Represent Just at external meetings and conferences

Qualifications

• Ph.D preferred in a relevant field (e.g. biochemistry/chemistry, analytical chemistry, biophysics, chemical engineering) with 10+ years of experience in the biopharmaceutical industry
• Strong expertise in some combination of UPLC/CE, biological characterization, structural/biophysical analysis, and/or mass spectrometry
• Experience with high throughput automation and data systems
• Experience in analytical method development and characterization for commercialization including CQA identification, risk assessments, specification setting, biosimilar assessment, validation.
• Strong knowledge of analytical regulatory guidelines (USP/Ph.Eur./ICH) and practices and experience authoring IND/IMPD/BLA/MA sections.
• Proven track record of scientific, management and leadership skills and ability to work collaboratively and flexibly in a team environment with other functions to solve problems and deliver on projects.
• Experience with FTE and capital planning tools, budgeting, allocation and tracking of resources and equipment
• Strong written and verbal communication skills, including the ability to communicate effectively over teleconference and web-based meetings

The base pay range for this position at commencement of employment is expected to be $200,000 to $230,000;  Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.