Process Development Scientist

Process Development Senior Scientist

Amgen's Commercial Attribute Sciences group in Thousand Oaks, California is seeking a Senior 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.

Key Responsibilities Include:

• 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

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

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.