Process Development Scientist - Pivotal Drug Product

Cambridge, Massachusetts
Jun 28, 2018
Required Education
Position Type
Full time

Amgen is currently seeking a Process Development Scientist for the development of lyophilized drug product presentations. The position is in our Pivotal Drug Product Technologies Department in Cambridge, MA. This group is responsible for late phase drug product development, including commercial formulation, commercial process, and life cycle management activities. The Scientist will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product and process development. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success through the commercialization process.

Responsibilities include:

  • Plan, design, execute, and document laboratory studies related to drug product design, formulation, and process development in support of commercialization and life cycle management
  • Lyophilization cycle development, heat transfer modeling, scale-up, and frozen/freeze-dried solid-state characterization for lyophilized biologic formulations, as well as, for alternative modalities (RNA, live modalities, etc.)
  • Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis
  • Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products during Commercialization, as well as, supporting commercial products in lifecycle management
  • Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
  • Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
  • Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs
  • Ability to travel domestically and internationally up to 10% of the time

Basic Qualifications:

  • Doctorate degree or Doctorate degree completed by September 2018
  • Master's degree & 4 years of scientific experience or
  • Bachelor's degree & 6 years of scientific experience

Preferred Qualifications:

  • Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related discipline
  • 2 years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field
  • Proficiency in lyophilization cycle development and frozen/freeze-dried solid-state characterization of large molecule biologics is a must and additional experience with alternate modalities
  • Knowledge of/hands-on experience with formulation development for lyophilized drug products
  • Prior experience related to lyophilization cycle development, modelling, heat transfer characterization, scale-up, and tech transfer. Deep understanding of cycle development and optimization
  • Proficiency in multiple solid-state characterization techniques (e.g. DSC, XRD, FDM, etc.) for the physical characterization of frozen and lyophilized drug product formulations
  • Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale-down model development, characterization, and scale-up
  • Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability.
  • Aseptic processing experience and familiarity with cGMPs
  • Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
  • Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function
  • Strong problem solving and effective cross-functional communication skills
  • Proven ability to learn and act on dynamic information at a rapid pace