Process Development Senior Scientist

Amgen Inc.•Thousand Oaks, CA

34d

About The Position

Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Senior Scientist What you will do Let's do this. Let's change the world. Amgen's Commercial Attribute Sciences group in Thousand Oaks, California is seeking a Principal Scientist. The successful candidate will join us on our effort to deliver innovative human therapeutics to patients worldwide by supporting Amgen's marketed biologic products responsible for analytical leadership of large molecule commercial programs and patient impact expansion/lifecycle management activities. The role will involve close partnership with local and global Quality and will also involve representation of Attribute Sciences on global cross-functional product teams that include partners such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC, and Supply Chain. The successful candidate will actively chart the course translating product-advancement business strategies into actionable scientific objectives and plans, routinely engaging with executive leadership on the communication of key developments. The successful candidate will also be given development opportunities to advance their own career in partnership with their manager.

Requirements

Doctorate degree PhD OR PharmD [and relevant post-doc where applicable] OR
Master's degree and 3 years of relevant experience OR
Bachelor's degree and 5 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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