Senior Research Associate/Senior Scientist, Pharmaceutical Development
About The Position
Ionis Pharmaceuticals seeks an experienced pharmaceutical development scientist to support laboratory experiments, review development data, and author and standardize technical reports for injectable drug products in development. The ideal candidate will be an independent self-starter with experience in analytical, formulation and process support for early and late-stage development of oligonucleotide-based drug products including conjugated with small molecules, peptides and proteins. The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail.
Requirements
- BS with a minimum of 5 years, MS with a minimum of 3 years, or PhD with a minimum of 2 years of related industry experience in Pharmaceutical Sciences, Bio/Chemical Engineering, Chemistry, Biochemistry, or related major
- Experience with compendial and separation methods (chromatography, electrophoresis) supporting preformulation, formulation development and development stability are required.
- Self-starter with proven skills in designing experiments, analyzing data sets including statistical treatment, presenting technical presentations and authoring technical reports
- Excellent communication skills and the ability to work independently as well as cohesively with internal and external cross-functional teams
- Able to think, perform independently, strategically, analytically, and creatively to solve technical and project challenges
- Knowledge of FDA, ICH, ISO, USP and relevant guidance documents in product development
- Good technical writing skills/experience
- Work efficiently and effectively in a fast pace, cross-functional environment with excellent time and project management skills to manage multiple time-sensitive projects.
- Strong interpersonal, communication, and collaboration skills along with strengths in meeting project deliverable(s).
Responsibilities
- Analytical support for formulation development, development stability and drug product manufacturing process development of early and late-stage parenteral drugs.
- Perform laboratory experiments to develop formulation and aseptic manufacturing processes and to assess development stability and characterize combination products.
- Statistical treatment of data sets including DOE
- Author and/or review of technical data and reports, summarizing development studies and supporting regulatory submissions, while ensuring scientific rigor and accuracy, and presentation clarity
- Author / review of drug product specifications, manufacturing batch records, stability protocols, stability data, expiration dating and related documents, ensuring timely data reporting for regulatory submission
- Work closely with cross-functional teams including Analytical, Drug Product, Device, Clinical, QA, and Regulatory to develop drug products while meeting regulatory requirements
- Perform other duties as assigned
Benefits
- excellent benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Senior
