Process Development Principal Scientist

Process Development Principal Scientist
What you will do

Let’s do this. Let’s change the world. In this vital role you will joining Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the‑art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) synthetic medicines (oligonucleotides and small molecules).

In this vital role as an Attribute Sciences team lead and group lead you will work to provide strategic analytical leadership to teams developing commercial manufacturing processes for synthetic and hybrid molecules and collaborate closely with Drug Substance, Drug Product and Product Quality colleague

• 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 Amgen’s 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 expertisewho can provide mentorship to junior staff.

We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is a leader with these qualifications.

Basic Qualifications:

• Doctorate degree PhD OR PharmD OR MD [and relevant post‑doc where applicable] and 3 years of [Job Code’s Discipline and/or Sub‑Discipline] experience
• Master’s degree and 6 years of Scientific experience
• Bachelor’s degree and 8 years of Scientific experience

Preferred Qualifications:

• PhD with 3+ plus years of industry experience.
• 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
• Knowledge of analytical method development and testing requirements toward solid oral dosage support (immediate and controlled release solid dosage forms, liquid formulation or lyophilized formulation), including dissolution method development.
• 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…