Sr. Scientist/Principal Scientist – Product Development Biologics

Sr. Scientist/Principal Scientist – Product Development Biologics

Requirements

• BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 8+ years (Sr. scientist) /12+ years (principal scientist) of pharmaceutical industry experience OR
• Master’s degree in Pharmaceutics, Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred and 6+ years (Sr. scientist) /10+ years (principal scientist) of similar experience noted above OR
• Ph. D. (preferred) in Pharmaceutics, Analytical Chemistry, Chemistry and 1+ years (Sr. scientist) /6+ years (principal scientist) similar experience noted above
• Thorough understanding of principles and design of various formulations (preferred experience in both peptides/proteins and antibodies)
• Extensive hands-on experience and knowledge of various formulations e.g., HPLC testing, etc.
• Good understanding of health authority regulations and guidelines for drug product development and approval processes
• Knowledge in statistics and statistical thinking in formulation and process design and validation
• Good knowledge of various drug product manufacturing processes
• Good understanding of drug development and commercialization processes
• Excellent capability in strategic thinking and planning
• Working knowledge in the following instrument/testing: HPLC, LCMS, DSC, Particle-Size Analysis, etc.
• Working knowledge in applying QbD principles in drug product development
• Technical writing: protocols, reports, SOPs, etc.

Responsibilities

• Establish relationships and actively manage external parties (CROs, CDMOs, Raw material suppliers, consultants, etc) to support biologics programs – Responsible for all process development-related activities and CMOs results, including Technology Transfer to CMO partner sites for manufacturing of different phases of clinical studies, registration stability lots, and validation batches
• Manage priorities and timelines while also creating value by devising new possibilities for IP, incorporating QbD principles when possible, and practicing the best/most practical technologies
• Prepare and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages, or other regulatory dossiers)
• Manage assessment capabilities within the Product Development Department, including sourcing & procuring instruments and equipment required to perform process and analytical studies
• Provide instrument/equipment and method training for other personnel to promote broad utilization of analytics capabilities within the PD department and CMC
• Proactively researches drug product manufacturing processes based on current regulatory and ICH guidelines for modern pharmaceutical development
• Assimilates data and research findings outside of Neurocrine for application to new scientific projects
• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
• May develop an understanding of other areas and related dependencies
• Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
• Ability to work as part of and lead multiple teams
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent computer skills, communication, problem-solving, and analytical thinking skills. sees the broader picture, and impact on multiple programs, teams, and/or departments
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills
• Candidate must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking.
• Must be highly organized and detail-oriented
• Hands-on experience with analytical techniques used for protein characterization and stability testing is required
• Search, assess, and share/teach up-to-date scientific and technical knowledge and information of various biologics formulation/process approaches related to the company’s drug product development programs
• Manage performance assessment testing capabilities (analytics) within the biologics group
• Provide instrument and method training for other personnel to promote the utilization of the biologics process and testing capabilities
• Work independently on assignments using knowledge and work experience; support other activities of drug product development programs when needed.

Preferred Qualifications

• Prior CMC development experience in protein formulation, lyophilization process development, drug delivery, or analytical functions is highly preferred