25 Feb
Scientist I/II, Oligonucleotide Formulation and Process Development
Massachusetts, Cambridge , 02138 Cambridge USA

Vacancy expired!

Job Description

  • Acting as technical representative in a cross functional team to support oligonucleotide drug product formulation development/characterizations, fill/finish process development/characterizations, technology transfer
  • Supporting preclinical and clinical program development, supply formulated tox materials and conduct stability studies
  • Performing drug product process development, optimization, scale-up, characterization and validation
  • Authoring and reviewing guideline documents, technical protocols, reports, process control strategy, risk assessments, and CMC regulatory filings
  • Delivering progress reports and presentations to promote management awareness and engagement of the status, progress, and future program and functional needs
  • Working effectively in a highly matrixed team environment to advance programs inspire change, improve efficiency, and foster positive relationships

Additional Responsibilities for Scientist II:

  • Function lead to drive continuous improvement in oligonucleotide formulation development process through technological advancements/innovations
  • Leading a working group for formulation development/innovation

Qualifications

  • General experience in oligonucleotide manufacturing process and drug product formulation is required
  • Experience in parenteral formulation, fill/finish process development, lyophilization development, process characterization, technical transfers to manufacturing sites or CMOs, and regulatory filings is preferred
  • Good knowledge of formulation, aseptic processing, sterility assurance, statistic modeling (DoE studies), regulatory fillings is preferred
  • Knowledge of, and hands-on experience with nanoparticle and or medical device delivery systems is a plus

Education:

  • Scientist I: B.S.(+6-8 years), M.S.(+4-6 years), or PhD (+0-2 years) in Biotechnology, Material Science, Engineering, Chemistry or related subject area
  • Scientist II: B.S.(+8-10 years), M.S.(+6-8 years), or PhD (+2-5 years) in Biotechnology, Material Science, Engineering, Chemistry or related subject area

Additional Information

All your information will be kept confidential according to EEO guidelines.

Vacancy expired!


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