Process Development Scientist

Amgen • Thousand Oaks, CA

1d • Hybrid

About The Position

Join Amgen’s Mission of Serving Patients. At Amgen, you are part of something bigger, driven by the shared mission to serve patients living with serious illnesses. Since 1980, Amgen has pioneered biotech in the fight against tough diseases, focusing on Oncology, Inflammation, General Medicine, and Rare Disease, reaching millions of patients annually. As a member of the Amgen team, you will help make a lasting impact by researching, manufacturing, and delivering innovative medicines. Amgen's culture is collaborative, innovative, and science-based, offering a thriving environment for those passionate about challenges. The Commercial Attribute Sciences group in Thousand Oaks, California, is seeking a Senior Scientist to deliver innovative human therapeutics by supporting Amgen’s marketed biologic products. This role involves analytical leadership for large molecule commercial programs and patient impact expansion/lifecycle management activities. The successful candidate will partner closely with local and global Quality teams and represent Attribute Sciences on global cross-functional product teams, including Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC, and Supply Chain. The role requires translating product-advancement business strategies into actionable scientific objectives and plans, with routine engagement with executive leadership for communication of key developments. Development opportunities are provided to advance the candidate's career in partnership with their manager.

Requirements

• Doctorate degree OR Master’s degree and 2 years of relevant experience OR Bachelor’s degree and 4 years of relevant experience

Nice To Haves

• 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 throughout the lifecycle of a product.
• Commanding knowledge of analytical methods/technologies such as Chromatography, CE, General Assays (e.g. pH, Osmolality, Karl Fisher titration, etc.), Gels, Bioassays and Immunoassays used to test diverse modalities including monoclonal and bispecific antibodies, bispecific T-cell engagers (“BiTEs”), synthetic peptides and biosimilar products
• Analytical project leadership experience
• Strong leadership skills and ability independently lead
• Solid understanding of GMP requirements and familiarity with USP monographs and chapters, as well ICH guidance documents related to analytical method transfer and validation
• Experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing.
• Strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements.
• Strong understanding of drug substance and drug product manufacturing processes
• Experience with regulatory filings and commercial quality systems
• Experience working closely with process engineers and quality control laboratories to generate and interpret analytical data to provide enhanced understanding and guidance around process understanding and control
• Experience with QbD and PAT, as applied to pharmaceutical development
• Experience managing and transferring commercial production and test methods
• Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
• A diplomatic approach – trusting and respectful interaction with global colleagues from a broad diversity of backgrounds – emphasis on listening
• Excellent technical writing skills and attention to detail in authoring technical reports and regulatory filing documents
• A self-starter and teammate with strong decision-making skills
• Ability to multitask, clearly plan and effectively follow through on complex deliverables

Responsibilities

• Lead analytical method lifecycle management activities including method remediation, improvements, and support method and 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 unexpected result root cause determinations
• Interface and collaborate with other functional areas in matrix environment, including team across various geographic locations in different time zones
• Duties may include establishing timelines, achievements, methodological approaches, expected results, necessary resources and communication to global cross-functional team members
• Prepare clear written and verbal communications to key customers and senior leadership
• Implementing innovative and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, investigations, and regulatory submissions, which may include laboratory activities
• Keeping current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities.
• Provide analytical leadership for post-approval CMC LCM projects, facilitate and manage testing activities in support of process characterization, PPQ, and analytical comparability studies, develop derisk strategies, provide oversight to analytical results for regulatory submissions.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees