Analytik NEWS
Online Laboratory Magazine
10/01/2022

Associate Scientist (m/f/d)

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Preferred Qualifications:

  • Master's degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related field.
  • 4+ 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 drug product unit operation (i.e. formulation, 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.
  • Experience with regulatory filings and compliance issues.
  • Proficiency in at least one statistical software package (such as SIMCA or JMP).
  • 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 interpersonal skills.
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
  • stablished ability to learn and act on dynamic information at a rapid pace.

Responsibilities include:

  • Participate in the planning, design, completion, and documentation of studies related to drug product design, formulation development, and process development in support of the commercialization and life cycle management of biologic therapeutics.
  • Author and review technical protocols, reports, and regulatory sections in support of submissions.
  • Evaluate process and product performance through analytical testing via measurement of pH, conductivity, osmolality, concentration, HPLC and CE methodologies, solid state characterization, and particle quantitation/characterization.
  • Actively use IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
  • Build 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 improvements of departmental practices by adding to guideline documents.
  • Participate in global cross-functional teams working efficiently in a highly matrixed environment to progress product development.
  • Deliver progress reports and presentations to ensure management awareness and engagement of current status, progress, and future program and functional needs.
  • Ability to travel domestically and internationally up to 10% of the time.


» Job description


Employer:
Amgen Ltd.
Location:
Thousand Oaks, California [Vereinigte Staaten]
Temporary:
No
Part-time:
No