Process Development Scientist

Amgen•Thousand Oaks, CA

1d•$111,941 - $151,449•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 part of the Amgen team, you will 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. This role is for a Senior Scientist in Amgen’s Commercial Attribute Sciences group in Thousand Oaks, California. The successful candidate will contribute to delivering innovative human therapeutics by providing analytical leadership for large molecule commercial programs and patient impact expansion/lifecycle management activities. The position involves close partnership with local and global Quality teams and representation of Attribute Sciences on global cross-functional product teams, including partners from Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC, and Supply Chain. The candidate will translate product-advancement business strategies into scientific objectives and plans, engaging with executive leadership on key developments, and will receive career development opportunities 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

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