Senior Scientist/ Assistant Director, 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.
SENIOR SCIENTIST/ASSISTANT DIRECTOR, PHARMACEUTICAL DEVELOPMENT
Ionis seeks an experienced pharmaceutical development professional to support clinical combination product development and cGMP manufacturing operations, along with lab scale development work and analytical testing. The ideal candidate will be an independent self-starter with experience coordinating projects and external vendors, designing and manufacturing sterile combination 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.
- Handle GMP contract manufacturing for clinical DP batches which may include review and implementation of manufacturing batch records, SOPs, stability protocols, analytical method transfer and validation protocols
- Set and justify DP specifications and author regulatory filing content, from early clinical studies through product registration
- Interface with outside parties including CMOs, vendors, and analytical labs
- Responsible for formulation and combination product development studies and associated reports including preformulation/formulation, in-use administration, extractable/leachables, container characterization, and device functionality to support regulatory compliance and submissions
- Perform and oversee analytical, physical, and functional testing including HPLC, LC/MS, viscosity, turbidity, osmolality, moisture content, UV/Vis spectrometry, break loose glide force, and container closure integrity
- BS or MS with at least 8 years of industry experience OR a PhD with at least 4 years of industry experience in a Pharmaceutical Sciences, Bio/Chemical Engineering, Chemistry, Biochemistry or related major
- Minimum of 4 years’ experience in the combination product development function including experience with GMP manufacture of sterile drug products and writing relevant sections of regulatory submissions
- Working knowledge of GMP, ICH, EMA and FDA CMC guidelines
- Demonstrated experience authoring and reviewing drug product sections of regulatory CMC submissions for parenteral combination products
- Experience developing drug-device combination products, including pre-filled syringes, autoinjectors etc., in compliance with current US and EU regulatory requirements
- Self-initiative and ability to work independently as well as part of a cross-functional team
- Excellent communication (written and verbal) and project coordination skills
The successful candidate will have a good understanding of the drug development process. It is anticipated that the candidate will have a good understanding of the science relating to critical product characteristics for parenteral drug-device combination products. Thus, the candidate is expected to have prior laboratory experience in related fields such as analytical/microbiological testing, physical characterization, formulation development, and device development. The candidate should work well within a multidisciplinary team with an ability to be productive and successful in an intense, fast-paced, work environment. Effective interaction skills, along with excellent oral and written communication ability, are an essential component of this position.
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 # 19-0023
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.