Associate Director/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.
ASSOCIATE DIRECTOR / DIRECTOR, PHARMACEUTICAL DEVELOPMENT
This position will be responsible for all aspects of sterile parenteral product development relating to the drug product configuration – including specifications, stability, manufacturing for clinical supplies and to assure successful regulatory filings from clinical through to commercial filings. Establishes a quality target product profile (QTPP) to underscore a development plan with strategic CMC and technical direction for the product configuration. Overall, the expectation for this position is to be a key player in both the planning and execution of the development strategy in a collaborative manner across corporate disciplines and with partners and contract facilities.
- Serve as the pharmaceutical development representative in corporate and partner project teams ~ assuring alignment of work scope to resources and budget.
- Ensure timely availability and continuity of clinical supplies with appropriate controls.
- Ensure GMP compliance to 21CFR part 211 and 820 (quality system regulations)
- Develop robust manufacturing processes with qualified analytical methods, through process changes, technology transfer, scale-up and stage-appropriate validations.
- Effectively manage contract manufacturing organizations (CMO) in line with internal and partner timelines and associated contract facilities.
- Working closely with QA, lead the technical aspects of product/process investigations
- Set and justify drug product specifications and author high quality regulatory filing content, through product registration – for US, EU and JP territories.
- Bachelor’s degree required, graduate degree preferred, in science or engineering.
- Minimum of 12 years’ experience in a pharmaceutical technical development to commercial discipline, with significant experience with sterile injectable products.
- Comprehensive understanding of cGMP requirements and stage appropriate CMC regulatory requirements, both domestic and international (i.e., ICH) for clinical and/or commercial pharmaceutical manufacturing.
- Demonstrated experience managing aseptic cGMP manufacturing operations, directly or outsourced, from initial tech transfer through method and process validation.
- Experience leading cross-functional teams across development functions: manufacturing, specifications, development studies (stress, E/L, etc.), stability, shelf-life, packaging etc.
- Demonstrated experience authoring and reviewing drug product sections of regulatory CMC submissions for parenteral products.
- Experience developing drug-device combination products, including pre-filled syringes, autoinjectors etc., in compliance with current US and EU regulatory requirements is a strong plus.
- Consideration given to individuals with strong drug delivery experience in non-parenteral routes of administration or novel dosage forms.
Excellent salary and benefits package offered.