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.
ASSISTANT DIRECTOR, PHARMACEUTICAL DEVELOPMENT
Ionis seeks an experienced pharmaceutical development professional to support clinical drug product formulations and cGMP fill/finish manufacturing operations, along with lab scale development work, and analytical testing. The ideal candidate will be an
independent self-starter with significant experience coordinating projects and external vendors, designing and manufacturing sterile injectable drug products under cGMP along with the demonstrated ability to author various reports and drug product sections
of 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.
- Design, perform and interpret experiments for preformulation and formulation studies.
- Conduct prototype stability, dose handling and administration, packaging and/or process qualifications, and 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.
- Set and justify drug product specifications and author regulatory filings assuring efficient integration across CMC and other relevant disciplines such as Clinical and Toxicology.
- Compose summary reports on preformulation, formulation, analytical, manufacturing, and related activities.
- Handle fill/finish contract manufacturing of GMP clinical batches which may include review and implementation of manufacturing batch records, SOPs, stability study, analytical method transfer and qualification/validation protocols.
- Interface with outside parties – CMOs, vendors, analytical labs, and partners.
- Other duties as assigned.
- BS or MS with at least 12 years of industry experience OR a PhD with at least 7 years industry experience, in a Pharmaceutical Sciences, Bio/Chemical Engineering, Chemistry, Biochem or related major.
- Minimum of 6 years’ experience in preformulation, parenteral formulation and process development, analytical development, cGMP fill/finish of sterile injectable drug products, and writing relevant sections of regulatory submissions.
- Self-starter and ability to work independently as well as part of a cross-functional team.
- Excellent communication (written and verbal) skills.
- Hands-on analytical and lab experience developing and characterizing formulations. Experience in HPLC and LC-MS is a strong plus.
The successful candidate will have a good understanding of the drug development process, particularly with respect to the inter-relationships of all key disciplines, including: Discovery, Pre-clinical, Technical CMC (drug substance/analytical & QC/drug product),
Quality, Clinical, and Regulatory Affairs. Experience in parenteral manufacturing is a plus, particularly aseptic processing along with terminal sterilization and scale-up considerations in a GMP environment – 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 critical product characteristics for parenteral product 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 # 18-0157
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.