Process Development Sr Associate - Pivotal Drug Product
Based in Cambridge, MA, the role of Process Development Sr. Associate in Pivotal Drug Product Technologies will provide support for Amgen's large molecule drug product formulation and fill/finish process development. The Sr. Associate will be responsible for performing formulation studies, evaluating the impact of process stresses on Drug Product attributes/stability, and process parameter definition for various fill finish unit operations. In addition, this role will focus on data analytics, statistical modeling, and data visualization.
- 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 various modality biologics (antibody, BiTE, other proteins, viruses, RNA).
- Perform analytical characterization supporting formulation attribute and stability assessments using chromatography and biophysical characterization tools (SE-HPLC, CE-SDS, DSC, NMR, HIAC).
- 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
- 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.
- Master's degree or Master's degree completed by December 2018
- Bachelor's degree and 2 years of scientific experience
- Associate degree and 6 years of scientific experience
- High school diploma / GED and 8 years of scientific experience
- 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.
- Experience with characterization of drug product formation and fill/finish unit operations (i.e. freeze/thaw, formulation, mixing, filtration, filling, and inspection)
- Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality
- In addition to proteins, 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.