Process Development Senior Scientist

Role Summary

Process Development Senior Scientist at Amgen, focusing on downstream purification development within the Pre-pivotal Bioprocess Development organization to support early clinical manufacturing of therapeutic molecules.

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, PharmD, or MD) with 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
  • Understanding of purification techniques for biological molecules (e.g., chromatography, depth filtration, viral filtration, tangential flow filtration, centrifugation)
  • Ability to independently author technical reports, regulatory filings, patents, and peer-reviewed publications
  • Ability to convey information and recommendations on scientific issues to senior management
  • Technical authority and ongoing engagement with relevant literature and technology
  • Collaboration 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
  • Ensures safe laboratory practices
  • Provides mentoring and expertise to less-experienced staff

Skills

• Purification process development
• Bioprocess development and scale-up
• Regulatory and CMC documentation support
• Viral clearance evaluation and quality/compliance focus
• Technical leadership and cross-functional collaboration

Education

• Doctorate, Master’s, or Bachelor’s with relevant experience as specified above

Additional Requirements

• Experience working in a cGMP manufacturing environment
• Mentoring and development of junior staff