||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 complex and challenging diseases. We are the pioneer in the discovery and development of antisense drugs
with more than 1600 patents.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our founding goals have changed little in over 28 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 you develop and expand your career.
Assistant Director Pharmaceutical Development
- Represent the drug product development function for multiple projects spanning clinical phases 1-3
- Coordinate fill/finish contract manufacturing of GMP clinical batches. Anticipate and troubleshoot issues
- Effectively manage clients and vendors, including: CMOs, vendors, analytical labs, and partners
- Design, perform, and interpret experiments for pre-formulation, formulation, stability, dose handling and administration, packaging and/or process qualifications
- Compose/review and implement manufacturing batch records, SOPs, stability study, analytical method transfer and process validation protocols
- Compose and justify appropriate drug product specifications
- Compose summary reports on pre-formulation, formulation, manufacturing, and related activities
- Prepare regulatory filings, assuring efficient integration across CMC and other relevant disciplines such as Clinical and Toxicology
- Offer occasional assistance in preclinical manufacturing and analytical testing
- Education: Minimum BS in Pharmaceutical Sciences, Bio/Chemical Engineering, Chemistry, Biochemistry or related major
- Experience: BS/MS: At least 8 years of industry experience. PhD: At least 4 years of industry experience
- Minimum of 6 years’ experience in the following areas:
- representing the drug product development function on cross-functional development teams
- cGMP fill/finish of sterile injectable drug products
- injectable drug product formulation and stability
- sterile product process development/transfer
- writing drug product sections of regulatory/CMC submissions
- Experience developing prefilled syringes and drug-device combination products (including human factors and design controls activities) is a strong plus
- Experience in HPLC and LC-MS is a plus
- Working knowledge of cGMP, ICH, EMA and FDA CMC guidelines
- Self-initiative and ability to work independently, as well as part of a cross-functional team
- Excellent communication skills and strong attention to detail
- Ability for approximately 10% domestic and international travel, depending on project assignments
Excellent salary and benefits package offered.
For more information about Ionis and to apply for this position, please visit our website,
www.ionispharma.com. Reference Requisition #17-0003
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. is proud to be an EEO employer.
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