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Senior Scientist I/II, Formulation

Location Novato, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives. 

Job Description Summary

The candidate is a highly motivated individual responsible for leading biologic protein and/or AAV gene therapy formulation and process development. The candidate should possess the skills to utilize a diverse array of analytical instruments to characterize protein and/or AAV formulations. The ideal candidate is a self-starter familiar with the literature and keeps up with new developments in the field and is thus able to identify opportunities for new innovation. Position makes use of scientific expertise and understanding of the industry to develop and contribute to complex company objectives. Position acts independently in selecting scientific approaches and defining acceptance criteria. Position regularly contributes proposals and influences decision-making within the department and technical teams, and at times beyond his/her own department and projects. Responsibility entails early formulation screening/characterization studies through late-stage formulation/process optimization and technology transfer to CMO. Develops conceptual designs and leads advanced independent or multi-disciplinary development projects driven by project needs. Provides technical leadership and guidance to formulation development and consultation to junior scientists on experimental designs and technical issues. The candidate has established scientific expertise in protein and/or AAV gene therapy formulation and process development. 

Responsibilities

  • Experimental design and strategic planning of drug product formulation development throughout all stages of non-clinical, clinical and commercial development
  • Collaborates in a matrix organization with Research, Preformulation, Process Development, Analytical Chemistry, Manufacturing (internal and external), Market Planning, and Regulatory Affairs to deliver project objectives
  • Serves as formulation representative on multi-disciplinary project teams
  • Provides scientific guidance and consultation to junior scientists on experimental designs, trouble shooting, data interpretation and technical challenges
  • Develops conceptual designs and experiments to solve technical issues
  • Leads the development and optimization of protein and/or AAV formulations
  • Serves as scientific monitor for outsourced formulation development, technology transfer or manufacturing at CMOs or CDMOs
  • Presents experimental results and recommendations to project teams, provides updates of project status, risks and mitigation strategies in the context of overall program goals
  • Generates written technical reports and contribute to regulatory submission documents
  • Develops protocols for various stability studies in collaboration with team members and external partners to support various programs in early and late stage development
  • Maintains state-of-the-art scientific knowledge, specifically with regard to biological drug product development and innovatively integrate new technologies into the work stream within the company

Education and years of industry experience

Advanced degree in Biochemistry; Pharmaceutics Sciences, or related fields with a minimum of 5 years of industry experience in biologic formulation development for Sr. Scientist I and a minimum of 8 years of industry experience in biologic development for Sr. Scientist 2.

Experience

  • Experience with biologic formulation development, characterization, testing, quality risk assessment and CMC regulatory guidance and filings
  • Must have in-depth understanding of the biophysical and biochemical degradation pathways for protein in liquid formulation
  • Solid understanding and familiarity with pharmaceutical characterization and testing equipment such as HPLC, DSC, UV Spectrophotometry, SEC-MALS, Fluorescence Spectroscopy, MFI, HIAC, SLS, DLS
  • Experience with GMP fill/finish process and equipment including Aseptic Filling Equipment, Production Capping Machine, Lyophilizer, etc. is preferred
  • Utilize DoE principles to design formulation screening/optimization studies and perform statistical analysis of collected data
Skills and Ability requirements
  • Excellent oral presentation and scientific writing skills are essential
  • Strong scientific contribution skills as demonstrated through patents, publications, technical reports, and approved regulatory submissions
  • A strong team player with good collaborative and people skills
  • Strong organization and prioritization skills, attention to details and ability for in-depth research and analysis
  • Highly motivated with the ability to resolve technical issues, develop and implement corrective solutions, be able to quickly adapt and respond effectively to changes
  • Ability to work in a fast paced environment, must be willing and able to juggle multiple projects at the same time
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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Novato

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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