Director of Cell Line Development page is loaded Director of Cell Line Development Apply locations Seattle time type Full time posted on Posted 4 Days Ago job requisition id JOB ID-10855
Director of Cell Line Development Process and Product Design, Seattle WA
Just-Evotec Biologics is looking for a Director of Cell Line Development to join a fast-paced, collaborative, and multidisciplinary team to lead all aspects of cell line development for the advancement of low-cost biotherapeutics manufacturing. The Director is responsible for strategic oversight and leadership of the full scope of cell line development (CLD) activities for novel biologics and biosimilars from pre-clinical through late stage development. Additionally, the Director leads the development of new technology including cell lines, vectors, and cell engineering to facilitate intensified, continuous manufacturing, rapid cell line generation, and biosimilar and second generation product development. This role requires a strong technical background in molecular biology, CLD and process development for biologics. A proven track record in cell line development, technology development, experience leading groups of scientists, experience with early and late stage regulatory filings and regulatory interactions is essential. Familiarity with analytical characterization and a working knowledge of CMC manufacturing is required.
Responsibilities
- Lead and grow a diverse group of CLD scientists to support all aspects of biologic cell line development from pre-clinical through late stage development
- Optimize strategies and workflows that increase efficiency and de-risk projects
- Passionate about development of new technology
- Lead efforts to identify, evaluate and champion new CLD technologies to support the mission of low cost biotherapeutics
- Collaborate across the organization and be a key member and contributor to the Process Design Leadership Team
- Be a technical resource on CLD 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 a CLD lead for complex projects and/or oversee leads on cross-functional project teams
- Manage and develop staff, and manage capital and resource planning
- Develop and refine CLD strategies that incorporate best practices and align with evolving regulatory expectations
- Support successful MCB and WCB manufacturing for client projects
- Represent Just at external meetings and conferences
Qualifications
- Ph.D preferred in a relevant field (e.g. biochemistry, chemistry, chemical engineering) with 7+ years, MS with 10+ years of experience, or equivalent experience in the biopharmaceutical industry
- Expert in cellular and molecular biology techniques to create stable cell lines suitable for protein therapeutics
- Experience with expression construct design for cell lines expressing large molecules, such as mAbs, fusion proteins, and bi-specifics
- Strong expertise in cell line development for protein therapeutics including experience with multiple mammalian cell lines
- Proficiency creating novel expression vectors to obtain highly productive cell lines that express material to meet process development product quality targets
- Experience in cell line development for commercialization of novel biologics and biosimilars, including experience designing cell lines to match innovator PQA/CQA
- Strong knowledge of regulatory guidelines and practices, and experience authoring IND/IMPD/BLA/MA sections
- Experience utilizing high throughput automation and data systems
- Proven track record of scientific, management and leadership skills with the ability to work collaboratively and flexibly in a team environment with other functions to solve problems and deliver on projects
- Experience with resource planning tools, capital planning and budgeting, and allocation and tracking of resources and equipment
- Excellent written and verbal communication skills, with expertise communicating effectively over teleconference and web-based meetings.
The base pay range for this position at commencement of employment is expected to be $127,050 - $235,950 ; 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.