Scientist, Biologics Analytical Development

4 weeks ago

Huntsville, United States TalentBurst, an Inc 5000 company Full time
  • Participates and occasionally leads in analytical method development and product characterization of recombinant proteins and conjugated proteins derived from microbial and/or mammalian expression systems.
  • Performs day-to-dayhands on operation for development and optimization of analytical methods.
  • Characterizes protein molecule and complex protein conjugates using various analytical methods, i.e. HPLC, icIEF, mass spectrometry, etc. Qualifies analytical methods phase appropriately.
  • Provides analytical support for upstream and downstream process development.
  • Oversees the activities at CROs for advanced characterization.
  • Involved in analytical method transfer and qualification/ validation at CROs/CMOs.
  • Oversees analytical results to support GMP production.
  • Reviews and/or authors the CMC sections of regulatory filing documents.
  • This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
  • Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Normally receives no instructions on routine work, general instructions on new assignments.
  • Analyzes multiple data sources and draws general, non-obvious conclusions.
  • Defines problems, develops approaches and develops experiments with sound judgment with minimal supervision.
  • Uses professional concepts and scientific knowledge to contribute to the development of company concepts and principles to achieve objectives in creative and effective ways. Interfaces with various departments and partners.
  • Plans and coordinates activities with other team members. Writes and/or approves complex reports and protocols.
  • Maintains knowledge of regulatory compliance requirements.
  • May assist with implementing organizational systems, identifying capital equipment, and projecting resource requirements.
  • May lead staff or a group, provides training as needed, and ensures adherence to company policies and quality requirements.

Education:

A PhD in a scientific or engineering discipline is required. Equivalent experience may be accepted.

A minimum of 2 years work experience in a biotechnology/pharmaceutical industry, preferably in analytical development, is required. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered.

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