Senior Process Analytical Scientist Oligonucleotide Lead

Amgen SA; Thousand Oaks (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Amgen is seeking a Process Development Sr Principal Scientist to lead a team of analytical scientists in developing, transferring, validating, and implementing analytical methods to support late-phase oligonucleotide programs through commercialization.

You will provide scientific, technical, and strategic leadership, shaping analytical control strategies and enabling successful process performance qualification and regulatory submissions.

Qualifications

• PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.
• Experience in pharmaceutical/biotech industry focusing on process/product development and analytical method development for small molecules, peptides, and/or oligonucleotides.
• Strong understanding of small molecule analysis, structure elucidation and solid-state characterization informed by knowledge of organic chemistry.
• Strong understanding of peptide and/or oligonucleotide structural elucidation and characteristics that relate to quality of peptide and/or oligonucleotide.
• Hands on experience in method development, validation, and transfer for in-process, release, and stability testing.
• Strong experience in oligonucleotide method development, characterization, and analytical control strategy especially having MS experience.
• Proficiency in MS, UV, NMR, FTIR and related techniques.
• Familiarity with USP monographs and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
• Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
• Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines.
• Excellent communication skills and ability to provide concise summary to cross-functional leadership and guidance to CMC and non-clinical teams.
• Ability to work effectively in cross-functional teams across geographic locations and time zones.
• Excellent technical writing skills with attention to detail in authoring methods, specifications, reports, and regulatory filings.

Responsibilities

• Lead and mentor a group of analysts in supporting process development and provide career guidance.
• Lead analytical method development for synthetic small molecules, peptides, and/or oligonucleotide manufacturing and testing.
• Collaborate with drug substance/product development teams to meet project objectives.
• Define analytical control strategies and implement methodologies for late-phase development.
• Provide concise summaries to cross-functional leadership for key decisions.
• Oversee activities at contract manufacturing and testing sites.
• Author technical reports and CMC sections in regulatory documents; address inquiries from health authorities.
• Manage cross-functional collaborations to enable PPQ and regulatory submissions and commercial launch.

Skills

Leadership

Analytical thinking

Communication

Cross-functional collaboration

Mentoring

Technical writing

Education

PhD in Analytical Chemistry

Doctorate in analytical-related field (PhD/PharmD/MD)

Master's degree with 5+ years scientific experience

Bachelor's degree with 7 years scientific experience

Tools

Mass Spectrometry (MS)

UV spectroscopy

NMR

FTIR

Job description

Amgen is seeking a Process Development Sr Principal Scientist to lead a team of analytical scientists in developing, transferring, validating, and implementing analytical methods to support late-phase oligonucleotide programs through commercialization.

You will provide scientific, technical, and strategic leadership, shaping analytical control strategies and enabling successful process performance qualification and regulatory submissions.