Job Details

Requisition Number 18-0102
Post Date 3/28/2018
Company Akcea
Title Senior Director, CMC Technical Lead
Employment Type Full Time
Description

Akcea Therapeutics is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious rare diseases. Our priority is to bring important new therapeutics to patients in need. In order to do so, we must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics. Akcea has a portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense therapeutics.

Akcea was established by Ionis Pharmaceuticals in late 2014 and was listed on the NASDAQ stock exchange in July 2017 under the symbol “AKCA.” Akcea is a global company headquartered in Cambridge, MA with offices in Carlsbad, CA and across the EU and Canada. 

Senior Director, CMC Technical Lead

The CMC Technical Lead will be responsible for managing drug product and packaging supply for Akcea’s two Rare Disease products, currently under review in the EU, US and Canada, as well as other products in Akcea’s development pipeline.  This individual will support all global launches and be held accountable for managing the relationships with the syringe filling and packaging suppliers.  In addition, the CMC Technical Lead will be responsible for development of the long term commercial supply strategy, including optimization of the existing external vendor portfolio to include manufacture, import/export, testing and release.  The role includes review of all vendor GMP documents (MBRs, specifications, change controls, validation plans, etc.) and maintenance of the design history file.

RESPONSIBILITIES

  • Lead the CMO relationships for manufacture of commercial drug product and packaging
  • Lead the project team for developing an alternate dosage form for at least one of the products
  • Work closely with the Ionis materials management team to ensure appropriate delivery of drug substance to the filling CMOs
  • Work closely with the quality team to ensure timely release of commercial drug product
  • Provide CMC support, as needed, for regulatory filings including new marketing authorization applications and questions from health authorities
  • Coordinate vendor submission aspects of annual product updates to regulatory filings
  • Work with associate director of product supply to measure CMO performance through implementation and trending of key performance indicators (KPIs).  Generate improvement plans as needed
  • Present as “Person-in-Plant” as needed during manufacturing runs
  • Coordinate the review, with Quality, of manufacturing documents, including MBRs, specifications, change controls, and deviations.  Ensure that client approval of all CMO documents is provided in a timely and efficient manner
  • Provide CMC input and support to development program teams
  • Maintain “inspection-readiness” of product Design History Files
  • Determine path forward for optimization of drug supply, including manufacturing, QC testing and QA release strategy for all commercial markets
  • Work with Ionis team to evaluate vendor capabilities of new CMOs or test laboratories
  • Provide input for S&OP (sales and operations planning) meetings regarding size and frequency of batch manufacture
  • Manage technical aspects of commercial artwork to support global product launches
  • Other responsibilities include oversight of drug product stability programs; tech transfer activities; drug product manufacturing process validation; drug product test method validation; resolution of CMC aspects of nonconformance, out-of-specification, and out-of-trend investigations; leachables / extractables studies; Human Factors studies; and development of relevant SOPs
  • Assist, as needed, with the management of vendors related to drug substance manufacturing and testing

TECHNICAL QUALIFICATIONS

  • BS / BA, and preferably an M.S. or Ph.D., in biological sciences, engineering, manufacturing, or science related field plus at least 10-15 years of relevant cGMP drug product manufacturing experience, and preferably with at least 20 years of pharmaceutical industry experience overall
  • Working knowledge of cross-functional drug development processes, FDA/ICH/EMA guidelines and cGMPs
  • Knowledge of cGMP, contracts, supply agreements, and quality systems as it relates to Contract Manufacturing Organizations
  • Full understanding of complex technical issues in drug product manufacturing and packaging.  Prior experience with antisense oligonucleotide manufacturing is a plus
  • Experience in orphan/rare disease commercialization is a plus
  • Hands on experience with commercial drug product fill / finish manufacturing
  • Hands on experience with commercial drug product global packaging requirements
  • Strong scientific background in analytical methods and experience with drug product stability requirements
  • Experience in leading CMO relationships
  • Experience working with drug development partners (e.g., large pharma companies)

CHARACTERISTICS

  • Strong leadership, communication and presentation skills and business partnering ability
  • Strategic, analytical and results-driven thinker with the ability to plan and direct
  • Resourceful and creative problem solver
  • Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment
  • Problem solving ability related to cGMP manufacturing, technical and regulatory
  • Strong interpersonal skills and ability to work with internal and external stakeholders in a positive, collaborative manner
  • Ability to travel (~10-20%)

 

Excellent salary and benefits package offered.

Please visit our website, www.akceatx.com, to apply for this position.

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Akcea Therapeutics, Inc. is proud to be an EEO employer.

Apply On-line
Send This Job to a Friend