Amgen Process Development Sr Associate - Pivotal Drug Product in Cambridge, Massachusetts

Based in Cambridge, MA, the role of Sr. Associate in Pivotal Drug Product Technologies will be to provide support for Amgen's biologics drug product and process design, commercialization and lifecycle management. The Sr. Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product and process development. In addition to performing process characterization and formulation studies, this role will also focus on data analytics, statistical modeling, and data visualization technologies. The Sr Associate will integrate and utilize platform capabilities, prior product knowledge, and data analytics/visualization to advance Amgen practices and ensure success through the commercialization process.

Responsibilities include:

  • Participate in the planning, design, execution, and documentation of studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management of biologics

  • Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions

  • Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.

  • Create visualizations to enable business application of data analysis

  • Explore and evaluate new digital tools and techniques to improve the team's developmental and operational capabilities

  • As needed, provide support 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

  • Support standardization and optimization of departmental practices by contributing to guideline documents

  • Participate in global cross-functional teams working effectively in a highly matrixed team environment to progress product development

  • 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

  • Master's degree

  • OR

  • Bachelor's degree and 2 years of scientific experience

  • OR

  • Associate degree and 6 years of scientific experience

  • OR

  • High school diploma / GED and 8 years of scientific experience

Preferred Qualifications

  • Master's degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related discipline

  • 2+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development, equipment design and implementation, technology transfers, statistical process control (SPC), and statistical design and analysis of experiments

  • Unit operation (i.e. filling, filtration, mixing, etc.) specific scale down models, characterization, and scale up

  • Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality

  • In addition to large molecules, experience with alternate modalities (RNA or live modalities) is a plus

  • Proficiency in at least one statistical software package (such as SIMCA or JMP)

  • Experience with data visualization tools or packages, such as Tableau or Spotfire

  • Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function

  • Aseptic processing experience and familiarity with cGMPs

  • Regulatory filings and compliance issues for sterile injectable products

  • Strong problem solving and effective cross-functional communication skills

  • Proven ability to learn and act on dynamic information at a rapid pace

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.