Isis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, is the industry leader in the discovery and development of antisense drugs. Isis was founded in 1989 in order to create advanced, novel medicines to treat complex and challenging diseases. We are the leader in antisense technology and drug development with a pipeline of 22 drugs (developed by Isis and its partners) and recent FDA approval for the cholesterol treatment, Kynamro™. The Company establishes partnerships with large pharmaceutical and smaller biotechnology companies that provide dedicated and focused drug development and technology in order to maximize the potential of the technology we pioneered. This strategy provides Isis with significant financial strength through a continuing stream of revenue from upfront license fees and milestone payments. In this way, we remain a powerhouse in antisense technology, discovering new ways to treat disease while remaining small with a core, dedicated group of employees.
Isis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our founding goals have changed little in 20 years and 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 developing and expanding your career.
Senior Scientist/Manager, Pharmaceutical Development
Isis seeks an experienced pharmaceutical development professional to support clinical drug product formulations and cGMP manufacturing operations, with occasional assignments in drug delivery formulations and preclinical testing. The ideal candidate will be an independent self-starter with significant experience coordinating projects and external vendors, designing and manufacturing sterile injectables under cGMP, and writing drug product sections of CMC regulatory submissions.
Duties and Responsibilities:
The successful candidate will be able to perform the following duties, spanning the entire scope of product development, with a high degree of independence and attention to detail:
•Create and implement manufacturing batch records, SOPs, stability study and process validation protocols
•Design, perform and interpret experiments for formulation or process qualifications
•Create and justify appropriate product specifications
•Prepare regulatory filings assuring efficient integration across CMC and other relevant disciplines such as Clinical and Tox
•Active coordination across multifunctional teams
•Interface with outside parties – CMOs, vendors, partners
•Initiate and handle contract manufacturing under cGMP, from Phase I thru commercial registration
•Prepare, organize and manage execution of technical due diligence plans
•Potential occasional assignments in drug delivery formulations and preclinical testing
•Other duties as assigned
BioSpace.com - 20 months ago