||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 has responsibilities over formulation, analytical, drug delivery, and for operational and support functions
for oligonucleotide clinical development through commercial registration.
- Serve as the pharmaceutical development representative in corporate and partner project teams assuring alignment of work scope to resources and budget.
- Handle fill/finish GMP contract manufacturing for clinical to commercial 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.
- Responsible for preform/formulation, and other development studies including prototype stability, dose handling–administration, extractable/leachables, packaging, investigations
and/or process qualifications to support GMP compliance and regulatory submissions.
- Perform and oversee analytical and physical testing including HPLC, LC/MS, viscosity, turbidity, osmolality, moisture content, and UV/Vis spectrometry.
- Compose reports on preform/formulation, manufacturing process, and related activities.
- Interface with outside parties including CMOs, vendors, analytical labs, and partners.
- Prepare, organize and manage execution of technical due diligence plans, as required during partnering considerations
The position will support all aspects of drug product formulations and cGMP fill/finish manufacturing operations, along
with laboratory development work, and analytical testing. The individual will be an independent self-starter with experience designing and manufacturing sterile injectable drug products under cGMP along with significant writing of various reports and drug
product sections of CMC regulatory submissions. The position has the additional responsibility to pursue the development of new formulations or delivery methodologies that may benefit the Ionis technology. The intent on this responsibility would be to identify
and prioritize those approaches considered of value to Ionis and to acquire proof of concept data which would show their utility to the oligo technology platform.
The position also works 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.
- 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.
Please visit our website,
www.ionispharma.com, for more information about Ionis and to apply for this position; reference requisition # 17-0116
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
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