Principal Scientist Drug Product Development | Process and Product Design, Redmond WA
Just-Evotec Biologics is looking for a Principal Scientist, Drug Product Development to lead a drug product development team working on protein biologics formulation development projects for the advancement of low-cost biotherapeutics manufacturing. The Principal Scientist is responsible for project and team leadership of drug product development activities for novel protein biologics and biosimilars from pre-clinical through commercialization. This role requires a strong technical background in protein drug formulation, process development, manufacturing and drug delivery. A proven track record of technical skills in this area, experience leading teams of associates and scientists and experience with early and late stage programs is essential. Experience transferring fill & finish process to third-party DP CMOs is preferred.
Responsibilities
- Lead and grow a diverse team of associates and scientists encompassing all aspects of protein drug product development from pre-clinical through to commercial.
- Serve as a formulation development lead on cross-functional project teams.
- Optimize strategies for formulation development, stability study design and execution, and drug product manufacturing that increase efficiency and de-risk projects.
- Collaborate across the organization and be a key member and contributor to the Drug Product Development team.
- Be a technical resource on formulation development for 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.
- Support successful DP manufacturing for client projects through external CMO’s.
Qualifications
- Ph.D preferred in a relevant field (e.g. biochemistry/chemistry, pharmaceutical sciences, formulation) with 7+ years, MS with 12+ years of experience in the biopharmaceutical industry.
- Strong expertise in protein formulation, DP process development and drug delivery for biologics and biosimilars including frozen, liquid and lyophilized formulations in vials, pre-filled syringes and devices.
- Experience in DP development for commercialization including risk assessments, process characterization and validation.
- Knowledge of regulatory guidelines and practices and experience authoring IND/IMPD/BLA/MA sections and USP/Ph.Eur.
- Experience with high throughput automation and data systems.
- 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 projects.
- Excellent written and verbal communication skills, including the ability to communicate effectively over teleconference and web-based meetings are necessary.
Compensation and Benefits
The base pay range for this position at commencement of employment is expected to be $140,000 - $170,000; Base salary offered may vary depending on the 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.
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