Process Development Senior Scientist

Role Summary

Process Development Senior Scientist

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 [and relevant post-doc where applicable]
• 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, etc.)
  • 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 Amgen’s 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 evaluation
• Regulatory filings support (CMC/IND)
• Cross-functional collaboration
• Technical documentation and communication
• cGMP manufacturing operations