Senior Scientist, Pharmaceutical Development at Isis Pharmaceuticals in Carlsbad, CA

Ionis Pharmaceuticals seeks an experienced pharmaceutical development professional to support drug product formulations, drug delivery, along with pharmaceutical development work and analytical testing. The ideal candidate will be an independent self-starter with experience in parenteral drug product formulation along with the demonstrated ability to author various technical reports supporting CMC regulatory submissions. 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.

RESPONSIBILITIES:

• Design, perform and interpret experiments for preformulation, formulation, and drug delivery studies.
• Conduct prototype stability, dose handling and administration, packaging and/or process qualifications, and managing extractables/leachables to support regulatory submissions.
• Perform and oversee analytical and physical testing including HPLC, LC/MS, viscosity, turbidity, osmolality, moisture content, and UV/Vis spectrometry.
• Assist in setting drug product specifications and managing and coordinating GMP drug product stability studies.
• Compose technical reports on preformulation, formulation, analytical, drug delivery, and related activities.
• Assist in managing fill/finish contract manufacturing of GMP clinical batches which may include authoring and review of manufacturing batch records, SOPs, stability study protocols, analytical method transfer and qualification/validation protocols.
• Interface with outside parties including CMOs, vendors, and analytical labs.
• Other duties as assigned.

REQUIREMENTS:

• BS or MS with at least 6 years of industry experience OR a PhD with at least 2 years relevant experience, in a Pharmaceutical Sciences, Bio/Chemical Engineering, Chemistry, Biochemistry or related major.
• Minimum of 3 years’ experience in preformulation, parenteral formulation, drug delivery, process development, and analytical development.
• Self-starter and ability to work independently as well as part of a cross-functional team.
• Hands-on analytical and lab experience developing and characterizing formulations. Experience in HPLC and LC-MS is desirable.
• Excellent communication (written and verbal) skills.
• cGMP fill/finish of sterile injectable drug products and writing relevant sections of regulatory submissions is a plus.
• The job is physically located in Carlsbad, California.