Process Development Senior Scientist

Role Summary

Process Development Senior Scientist in Amgen’s Commercial Attribute Sciences group. Lead analytical method lifecycle management and contribute to regulatory filings for large molecule commercial programs, partnering with Quality and cross-functional teams to translate business strategies into actionable scientific objectives.

Responsibilities

• Lead analytical method lifecycle management activities including method remediation, improvements, and support method validation and transfers
• Contribute to global regulatory filings by authoring analytical CMC sections and RTQs ensuring success of commercial approval and launch
• Independent authorship and review of technical reports, variations and responses to analytical questions from health authorities
• Provide analytical method subject matter expert leadership support of product quality and method-related investigations including OOS/OOT and root cause determinations
• Interface and collaborate with other functional areas in a matrix environment across geographic locations and time zones
• Establish timelines, milestones, methodological approaches, expected results, resources, and communicate to global cross-functional team members
• Prepare clear written and verbal communications to key customers and senior leadership
• Implement innovative and fit-for-purpose analytical methods for release/testing, stability, product characterization/optimization, investigations, and regulatory submissions
• Stay current in analytical development through literature and technology development for regulatory-driven activities
• Provide analytical leadership for post-approval CMC lifecycle management projects, support process characterization, PPQ, and analytical comparability studies, and develop derisk strategies

Qualifications

• Basic Qualifications:
  • Doctorate degree (PhD or PharmD) [and relevant post-doc where applicable] OR
  • Master‚Äôs degree with 3 years of relevant experience OR
  • Bachelor‚Äôs degree with 5 years of relevant experience
• Preferred Qualifications:
  • Advanced degree in Bioanalytical Chemistry, Analytical Chemistry, Biochemistry, Biochemical or Chemical Engineering
  • 3+ years pharmaceutical/biotech experience in process development and analytical method development
  • Deep understanding of product quality attributes and control strategies, quality attribute assessments, and Quality Target Product Profile lifecycle
  • Knowledge of analytical methods/techniques (Chromatography, CE, pH, Osmolality, Karl Fischer, Gels, Bioassays/Immunoassays) for diverse modalities
  • Analytical project leadership experience
  • Strong leadership and independent work capability
  • Understanding of GMP, USP, ICH guidance related to analytical transfer/validation
  • Experience with developing/implementing/commercializing methods for in-process testing, characterization, release, and stability
  • Understanding of regulatory expectations for analytical control strategies
  • Experience with regulatory filings and commercial quality systems
  • Experience collaborating with process engineers and quality control labs to interpret analytical data
  • Experience with QbD and PAT in pharmaceutical development
  • Experience transferring commercial production and test methods
  • Strong communication and cross-functional leadership for CMC/non-clinical teams
  • Diplomatic, inclusive collaboration with global colleagues
  • Excellent technical writing and attention to detail
  • Self-starter with strong decision-making skills
  • Ability to multitask, plan, and follow through on complex deliverables

Skills

• Analytical method development and lifecycle management
• Regulatory CMC documentation and RTQ preparation
• Cross-functional collaboration and leadership
• Technical writing and data interpretation
• Quality systems and GMP knowledge

Education

• PhD/PharmD or Master‚Äôs/Bachelor‚Äôs with relevant experience as specified