Sr. Research Associate/ Sr. Scientist, Pharmaceutical Development
Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
Sr. Research Associate / Sr. Scientist, Pharmaceutical Development
Ionis seeks an experienced pharmaceutical development professional to support clinical drug product formulations and manufacturing operations, to conduct lab scale development work and analytical testing, and to author various reports supporting CMC drug product development. The successful candidate will be able to perform the following responsibilities, which span the scope of product development, with a high degree of independence and attention to detail.
- Perform preformulation and physiochemical research studies as directed
- Conduct prototype stability, dose handling and administration, packaging and/or process qualifications to support regulatory submissions
- Perform analytical and physical testing including HPLC, LC/MS, viscosity, turbidity, osmolality, moisture content, and UV/Vis spectrometry
- Formulation development of various dosage forms and routes of delivery
- Potential occasional assignments in drug delivery formulations and manufacture aseptic solutions for use in preclinical/research studies
- Clearly document all work in batch records and laboratory notebooks
- Summarize work in both written and verbal communications
- Compose summary reports on preformulation, formulation, analytical, manufacturing and related activities
- Support GMP operations including drug product stability studies, data integrity review and maintaining relevant datasets
- Other duties as assigned
- BS / MS degree with at least 5 years industry experience, or Ph.D. with at least 1 year of industry experience, in Biology, Chemistry, Pharmaceutical Sciences, Bio/Chemical Engineering or related major
- At least 1year industry experience in formulation development, characterization, and aseptic processing, or related areas
- Hands-on lab experience developing and characterizing formulations
- Hands-on HPLC analytical experience with LC-MS, SEC experience as a strong plus
- Experience in a GLP or GMP regulated environment is a strong plus
- Experience in drug-device combination products is a strong plus
- Excellent written and verbal communication skills
- Excellent organizational abilities in a fast paced, cross-functional environment
- Position level may be adjusted as appropriate to the candidate’s qualifications
The successful candidate will have a good understanding of the drug development process. Experience in in a GLP/GMP environment is a plus – where strong attention to detail is required for both data integrity and good scientific principles. It is anticipated that the candidate will have a good understanding of the science relating to product characteristics for early-stage drug product configurations, especially parenteral configurations. Thus, the candidate is expected to have prior laboratory experience in related fields such as analytical/microbiological testing, physical characterization or formulation development. The candidate is expected to work with a sense of urgency within a multidisciplinary team to be both productive and yet thorough even during intense timelines.
Excellent salary and benefits package offered.
Please visit our website, www.ionispharma.com, for more information about Ionis and to apply for this position; reference requisition #19-0037
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Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.