Process Development Senior Scientist

Role Summary

Process Development Senior Scientist. Amgen seeks a Process Development Scientist within the Pre-pivotal Bioprocess Development organization in Thousand Oaks, CA. Focus is downstream purification development for early clinical manufacturing, including molecule assessments, clone selections, FIH purification process development, and tech transfers to clinical manufacturing. Development and implementation of new purification technologies, authoring regulatory CMC documents, and evaluating viral clearance.

Responsibilities

• Leading a team of purification scientists to develop processes for clinical manufacturing
• Applying technical and platform knowledge to design studies for the development of purification processes
• Serving in cross-functional or cross-site roles
• Contributing to the scientific literature and conferences, gaining recognition as a subject-matter expert in both internal and external purification communities
• Investigating and implementing relevant new technologies
• Interfacing with regulatory agencies in support of CMC filings
• Analyzing and presenting data internally for governance and technical meetings
• Contributing to viral clearance process evaluations and company strategies

Qualifications

• Basic Qualifications:
  • Bachelor’s degree and 5 years of Scientific experience OR
  • Master’s degree and 3 years of Scientific experience OR
  • Doctorate degree PhD OR PharmD OR MD
• Preferred Qualifications:
  • Doctorate in Chemical Engineering, Biochemistry, Biology, or related discipline
  • Experience contributing to and/or participating in purification science
  • Expertise and experience in purification process development
  • Extensive experience in development and/or support of bio-manufacturing processes, including process scale-up and GMP production
  • Track record of innovation and implementation of new technologies
  • Experience in authoring IND sections and interaction with regulatory agencies
  • Experience in viral clearance evaluation per ICH Q5A guidelines
  • Understands purification techniques for biological molecules (e.g., chromatography, depth filtration, viral filtration, tangential flow filtration, centrifugation)
  • Independently authors technical reports, regulatory filings, patents, and peer-reviewed publications
  • Capable of conveying information and recommendations on scientific issues to senior management
  • Serves as a technical authority and keeps current in relevant literature and related technology
  • Works cross-functionally to author CMC documents in support of regulatory filings
  • Develops processes to deliver multi-kilogram quantities of drug substance to cGMP operation
  • Leads deliveries of drug substance in a cGMP manufacturing environment in both internal and external capacity
  • Ensures that safe laboratory practices are followed
  • Provides mentoring and expertise to less-experienced staff

Skills

• Purification process development
• Viral clearance assessment
• CMC documentation for regulatory filings
• Cross-functional collaboration and leadership
• Technical writing and data presentation

Education

• As listed in Basic Qualifications/Preferred Qualifications above