Senior Scientist, Formulation Development
Our client is a leading, high growth biotechnology company. They have asked us to assist them in a search for a Senior Scientist, Formulation Development.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Develops formulations for pulmonary delivery, characterizes inhalation device performance, analyzes
data, and presents results to various stakeholders.
- Acts as a technical expert for formulation development and device characterization.
- Works with process development staff to implement selected formulations.
- Authors work instructions and SOPs.
- Trains junior staff where required.
- Participates in related CMC activities when required.
- Contributes to regulatory submissions.
- A PhD with 3 years of post-graduation experience or MS with 4-6 years of post-graduation experience in Pharmaceutical/Biological sciences or equivalent is required.
- Requires hands-on experience with formulation studies.
- Experience in GLP or GMP regulated environments is preferred.
- Extensive hands-on experience in DNA / RNA formulation, medical device characterization, and oligonucleotide product analysis is required.
- Must understand functionality and acceptability of excipients for different administration routes.
- A practical user of statistical design, modeling and application to data is preferred.
- General knowledge of viral vector based in vivo gene therapy is highly desired.
- Requires a basic understanding of viral vector drug substance bioprocessing unit operations.
- Experience in analytical method development, qualification and implementation is preferred.
- Requires the ability to adapt and perform in a fast paced and changing environment.
- Meticulous record-keeping and documentation practices and experience with electronic laboratory notebooks is preferred.
- The ability and willingness to train, mentor and guide junior staff is required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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