Process Development Sr Scientist - Pivotal Drug Product

Employer
Amgen
Location
Cambridge, Massachusetts
Posted
Jun 28, 2018
Ref
R-58785
Required Education
Doctorate/PHD/MD
Position Type
Full time

Amgen is currently seeking a Process Development Senior Scientist for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage drug product development for various modalities (large molecule, RNA, virus) including commercial formulation, commercial process, and life cycle management activities. The Senior Scientist will provide technical leadership while integrating and successfully utilizing information generated by cross functional teams (including product, process, delivery systems, packaging, engineering, analytical, quality, regulatory, and clinical/commercial manufacturing) to positively influence Amgen practices and ensure success through the commercialization process.

Responsibilities include:

  • Oversee and participate in the planning, design, execution, and documentation of studies related to drug product design, formulation, and process development in support of commercialization and life cycle management
  • Manage a team of engineers and scientists to advance program and functional objectives
  • Expand the utilization of advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis
  • Serve as a leader within Drug Product Commercialization Teams responsible for conducting process development on pipeline products during commercialization as well as supporting commercial products in lifecycle management
  • Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
  • Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering
  • Serve as subject matter expert in drug product technologies and help drive best practices and technical advancements across Amgen fill-finish network
  • Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs
  • Participate and lead global cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
  • Ability to travel domestically and internationally up to 10% of the time

Basic Qualifications

  • Doctorate degree & 2 years of scientific experience or
  • Master's degree & 5 years of scientific experience or
  • Bachelor's degree & 7 years of scientific experience

Preferred Qualifications

  • Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related discipline
  • 8 years of experience in pharmaceuticals/biotechnology
  • 5 years of 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
  • Leadership of highly technical experts with demonstrated results driving forward pipeline and lifecycle management programs
  • Knowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems
  • Experience participating and leading global cross-functional teams
  • Superior knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings
  • Strong problem solving and effective cross-functional communication skills
  • Proven ability to learn and act on dynamic information at a rapid pace