25 Feb
Scientist I/II, Oligonucleotide Formulation and Process Development
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
- 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
- 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!