Senior Scientist, Product Development
Our client is a biotechnology company. They have asked us to assist them in a search for a Senior Scientist, Product Development.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Leads design and optimization of formulation strategies to enable early phase Drug Substance and Drug Product manufacturing.
- Designs, executes, and analyzes systematic experiments to define the dosage form, formulation, formulation process design, and formulation process scale up across all c3DNA Drug Substance and Drug Product presentations, including naked or nanoparticle encapsulated c3DNA.
- Leads experiments to demonstrate robust formulation process performance within the defined design space.
- Leads and supports development of novel physiochemical characterization methods.
- Leads tech transfer of formulation and drug product processes to manufacturing sites and CMOs.
- Leads development of raw material testing strategies as appropriate.
- Provides expertise in cross-functional formulation, process, and analytical investigations.
- Authors and reviews relevant documents and reports.
- Leads development and innovation projects for continuous improvement of formulation and drug product processes.
- Works collaboratively to advance the company’s platform and pipeline.
- Works closely with external academic and industry collaborators.
- Works closely with contract manufacturers for outsourced development activities.
- Publishes in peer-reviewed journals and presents externally at industry forums and conferences.
- A PhD or equivalent in Biological Engineering, Chemical Engineering, Chemistry or related discipline with at least 4 years of relevant industry experience in a drug development setting or a Master’s degree with at least 8 years of relevant industry experience is required.
- Must have demonstrated experience with formulation development, analytical development, chemistry, and nanoparticle technologies.
- A demonstrated experience of biophysical and light scattering techniques is required.
- A demonstrated experience of drug product manufacturing processes is required.
- Must have a working knowledge of GLP/GMP requirements.
- Requires a strong understanding of aseptic fill-finish unit operations.
- Experience with nucleic acid drug development is preferred.
- Experience authoring regulatory submissions is preferred.
- Previous use of DOE methods in development setting is strongly preferred.
- Strong, demonstrated leadership skills are required.
- Excellent verbal and written communication skills are required.
- Must have experience presenting complex data and strategy to cross-functional teams.
- Must have experience mentoring, coaching, and growing individuals within a team.
- Must be organized, detail-oriented, and a self-starter who continuously seeks innovative solutions.
- The ability to collaborate and provide leadership in a global cross-functional environment is required.
- Requires the ability to work well in a fast-paced startup environment.
- Must have a track record of publishing patents and scientific articles in peer-reviewed journals.
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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