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Process Development Sr. Associate - Pivotal Drug Product

Employer
Amgen
Location
Cambridge, MA, US
Start date
Mar 22, 2019

View more

Discipline
Engineering, Marketing, Science/R&D, Pharmacology
Required Education
Associate Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

Position Description

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 Master's degree completed by June 2019
  • 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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