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Associate Director, Quality Assurance / Quality Control

Ionis Pharmaceuticals, Inc.

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Boston, MA
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Job Description

As posted by the hiring company

Job Overview:

For more than 30 years, Ionis Pharmaceuticals has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology.  Scientific innovation began and continues at Ionis with the understanding that sick people depend on us.

As the first company to fully harness the power of RNA technology for human therapeutics, our platform continues to revolutionize drug discovery and transform the lives of patients with unmet needs.  Our medicines span multiple therapeutic areas, routes of administration and diverse patient populations.  Ionis innovation is driving meaningful progress for many of the most challenging health issues.

We are building upon our innovative research and drug development excellence to provide greater value to patients.  Based on the breadth and remarkable progress of our pipeline, Ionis is projecting to have a vast number of new transformational products on the market in the coming years and growing our commercial capabilities.  We are well positioned financially to deliver on our strategic goals.

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 a diverse workforce, comprised of individuals from different backgrounds and with unique skill sets, into our creative and productive environment.  Join us and experience our unique culture while you develop and expand your career.

 

Associate Director, Quality Assurance / Quality Control


SUMMARY:

Reporting to the Executive Director, Commercial Quality, the Associate Director, Quality Assurance / Quality Control will be working with contract manufacturing sites (Drug Substance) and test laboratories to ensure compliance with processes and specifications for all Ionis products. The candidate should be familiar with a broad range of manufacturing and analytical techniques, experience working in a GMP environment, possess a good understanding of API and Drug Product manufacturing/processing, strong work ethic, and good communication skills.


RESPONSIBILITIES:

The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail.

  • Manage outsourced manufacturing (Drug Substance) and analytical activities for commercial and late-stage drug products including Release testing and Stability testing
  • Manage the Drug Substance manufacturing technical relationships with Contract Manufacturing partner (includes data review, production schedules, process changes)
  • Review analytical data for compliance to SOPs (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
  • Manage and trend stability study data and feed into APQRs and QMRs, as appropriate
  • Assemble and document data for Quality Assurance review (manufacturing and analytical)
  • Revise SOPs as needed (e.g. Analytical Methods, Stability Studies, Material Specifications)
  • Author or review qualification/validation protocols, transfer protocols, and write reports
  • Author scientific reports and analytical chemistry portions of Chemistry, Manufacturing, and Controls (CMC) section of regulatory filings, Annual Reports, and updates to IND’s and IMPD’s
  • Conduct analytical investigations and troubleshoot technical challenges at contract Drug Substance sites and testing laboratories
  • Interface with outside parties – manufacturing sites, contract labs and partners
  • Applies knowledge of cGMP daily


QUALIFICATIONS:

  • BS or MS with at least 8 years or a PhD with at least 6 years industry experience in Analytical Chemistry or a related field under a GMP environment
  • Practical and working knowledge of cGMP requirements
  • The successful candidate will have a good understanding of the drug development process and key disciplines, including:
  • Technical CMC (drug substance/analytical & QC/drug product), Quality, Clinical, and Regulatory Affairs
  • Excellent communication (written and verbal) skills
  • Excellent scientific, technical and critical thinking skills
  • Ideally, hands-on analytical and lab experience in HPLC, GC and LC-MS
  • The candidate is expected to be a self-starter, work with a sense of urgency within a multidisciplinary team to be both productive and yet thorough even during intense timelines


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 #IONIS002927

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.