Process Development Principal Scientist

About the role

The Process Development Principal Scientist will join Amgens Attribute Sciences (AS) department within the Process Development (PD) organization. This role focuses on defining favorable quality characteristics of therapies produced and optimizing advanced analytical tools to guide development.

Responsibilities

• Lead all attribute and analytical aspects of a program in pivotal clinical process development while working cross-functionally within a Product development team
• Define analytical control strategies and implement methodologies for development of late phase clinical programs including analytical method development and optimization
• Lead method transfer and support cGMP manufacturing activities at internal manufacturing, and contract manufacturing and testing sites
• Author technical reports and analytical Chemistry, Manufacturing and Controls (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
• Maintain current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities and apply this knowledge to the evaluation and development of new methodologies
• Recognized as a scientific resource in area of expertise who can provide mentorship to junior staff

Requirements

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 3 years of [Job Codes Discipline and/or Sub-Discipline] experience
• OR Masters degree and 6 years of Scientific experience
• OR Bachelors degree and 8 years of Scientific experience

Qualifications

• Strong understanding of small molecule analysis including chromatographic and spectroscopic techniques with an emphasis toward separation science, Process Analytical Technologies (PAT) for process understanding and process control, structure elucidation and solid-state characterization
• Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner
• Hands on experience in development, validation, transfer and remediation of methods for in-process, release and stability testing
• Knowledge of the major Pharmacopeia and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development
• Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations
• Ability to multitask managing deliverables on complex projects against timelines
• Strong leadership, problem solving, decision making and communication skills with the ability to work cross-functionally and globally within CMC teams to deliver results
• Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents

Skills

• Leadership
• Problem Solving
• Decision Making
• Communication
• Technical Writing

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