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Senior Scientist/Manager

Isis Pharmaceuticals, Inc.

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Location: San Diego, CA Posted Date: 4/19/2013 Position Type: Full time Job Code: Req. 458 Salary: DOE Required Education: Bachelors Degree Areas of Expertise Desired: Biochemistry
Chemical Engineering
Chemistry
Engineering

Description

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

Summary:

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

Requirements

Education, Experience and Other Requirements:

•BS or MS with at least 6 years of industry experience OR a PhD with at least 3 years of industry experience, in a Pharmaceutical Sciences, Bio/Chemical Engineering, Chemistry, Biochemistry or related major
•Minimum of 3 years industry experience in a leadership role for pharmaceutical development CMC, including experience with GMP manufacture of sterile drug products and writing of relevant sections of regulatory submissions
•Working knowledge of GMP, ICH, EMA and FDA CMC guidelines
•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
•Ability for approximately 10% domestic and international travel, depending on project assignments
•Hands-on analytical and laboratory experience developing parenteral drug delivery formulations is a plus (sustained release, topical, ocular, pulmonary, etc)

The successful candidate will have knowledge and understanding of the drug development process and a strong attention to detail. Experience in parenteral manufacturing is required – particularly aseptic processing and scale-up considerations in a GMP environment. This knowledge base requires a comprehensive and detailed understanding of the science relating to critical product characteristics for such product configurations. Thus, the candidate is expected to have had prior laboratory experience in related fields such as analytical/microbiological testing, physical characterization or formulation development. The candidate must also work well within a multidisciplinary team with an ability to be productive and successful in an intense work environment.  

Excellent salary and benefits package offered.
For more information on Isis and to apply for this position, please visit our website, www.isispharm.com.  Reference Requisition #458
NO PHONE CALLS PLEASE.  PRINCIPALS ONLY.

Isis Pharmaceuticals, Inc. is proud to be an EEO employer.
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