Process Development Sr Scientist

About the role

The Process Development Sr Scientist will join Amgens Attribute Sciences (AS) department within the Process Development (PD) organization. The PD organization defines favorable quality characteristics of therapies produced and optimizes advanced analytical tools to guide development. The senior scientist will provide strategic analytical leadership for programs in pivotal clinical process development, overseeing all analytical work to support the program.

Responsibilities

• Supervise and provide technical support for a team providing analytical support for late-stage product development
• Act as an Attribute Sciences Team lead for a program in pivotal clinical process development, responsible for all analytical work to support the program
• Define the analytical target profile (ATP) for methods used to monitor product quality. Based on ATP, oversee the development, qualification, remediation, and transfer of analytical methods to Quality Control
• Manage activities at contract manufacturing and testing sites
• Author technical reports and analytical CMC sections in regulatory documents. Answer analytical and product quality questions from health authorities
• Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification
• Provide expertise and evaluation of Amgens platform and analytical technologies, helping to drive innovation and efficiency within Process Development
• Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department

Requirements

• Doctorate degree
• OR Masters degree and 2 years of directly related life science experience
• OR Bachelors degree and 4 years of directly related life science experience
• OR Associates degree and 8 years of directly related life science experience
• OR High school diploma / GED and 10 years of directly related life science experience

Qualifications

• Doctorate degree with 5-7+ years in Analytical Chemistry, Biochemistry or equivalent
• Relevant experience working as part of a multidisciplinary team in a biopharmaceutical setting would also be an advantage
• Strong background in analytical method development of biologics such as monoclonal antibodies and multispecifics
• Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF
• Demonstrate knowledge of regulatory requirements and guidelines and prior experience authoring or contributing to regulatory filings
• Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as glycosylation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools
• Strong problem solving and effective multi-functional interpersonal skills
• Able to develop, validate, transfer and remediate methods for in-process, release and stability testing
• Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (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, managing deliverables against timelines
• Strong communication skills and ability to provide cross-functional leadership and guidance to Chemistry, Manufacturing, and Controls (CMC) and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
• Works well in cross-functional teams, and across various geographic locations in different time zones
• Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents
• Experience with protein-based and live modality therapies is beneficial (monoclonal antibodies, bi/tri-specific antibodies, fusion proteins, gene therapy, etc.)
• A self-starter and team player with strong leadership and decision-making skill

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 where possible

Pay

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.

Schedule

Full time