Process Development Scientist – Pivotal Drug Substance Technologies
Amgen Inc
Cambridge
6d ago

Amgen’s Process Development organization is seeking a Process Development Scientist in Thousand Oaks, CA or in Cambridge, MA locations to join the Pivotal Drug Substance Technologies team and will be principally concerned with translating developmental processes into commercial manufacturing reality using synthetic organic chemistry through scientific expertise, engineering innovation and deployment of manufacturing technologies.

Pivotal Drug Substance Technologies team responsible for developing innovative solutions to prepare our small molecule and hybrid drug candidates.

Key Activities for the Process Development Scientist include :

  • Develops technology to manufacture drug candidates in a practical, efficient, and safe manner
  • Champions innovative applications of synthetic chemistry, pharmaceutical manufacturing, process analytical technologies (PAT), automation, and data analysis
  • Provides significant contributions to drug substance development teams (e.g., product and process development teams, product quality teams) by providing drug substance updates, documentation, data interpretation, technical recommendations, etc.
  • Serves as a technical expert and keeps current in organic chemistry and applications of process technology in pharmaceutical development including literature and technology development
  • Improves the technical or scientific capabilities of the department and routinely answers questions on or resolves scientific / technical issues
  • Collaborates in cross-functional teams to develop Amgen’s pipeline
  • Works cross-functionally to deliver regulatory documents and supporting documentation in support of Amgen’s regulatory filings
  • Delivers processes amenable to current Good Manufacturing Practice (cGMP) operation and carry out deliveries of drug substance in a cGMP manufacturing environment
  • Basic Qualifications : Doctorate degree

    Doctorate degree

    Master’s degree and 4 years of scientific experience

    Bachelor’s degree and 6 years of scientific experience

    Preferred Qualifications :

  • Doctorate degree in Organic Chemistry, Medicinal Chemistry or Synthetic Chemistry
  • Post-doctoral research experience
  • Track record of demonstrated scientific accomplishments in the field of organic chemistry
  • Ability to champion new technologies
  • Experience in the pharmaceutical / biotech or related industry that includes participation and contribution to scientific project teams
  • Familiarity with common industrial unit operations including crystallization (batch and continuous mode), filtration and drying
  • Familiarity with the use of design of experiments (DoE) and Process Analytical Technology (PAT) techniques
  • Familiarity with laboratory automation, data analysis and visualization techniques and tools
  • Familiarity with Environmental Health and Safety expectations for chemical laboratories
  • Familiarity with current Good Manufacturing Practices for preparing drug substances and intermediates
  • Demonstrated ability to effectively work in a fast-paced team environment
  • Excellent interpersonal, presentation, written and verbal skills
  • Knowledge of basic office and chemistry software including Microsoft Word, Excel, PowerPoint, ChemDraw, SciFinder, and electronic laboratory notebooks
  • Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives.

    A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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