Job Details

Requisition Number 16-0107
Post Date 9/19/2017
Company Akcea
Title Associate Director, Drug Product Manufacturing
Employment Type Full Time
Description

 

Akcea Therapeutics, Inc. is a development and commercialization company focused on impacting the lives of patients with serious cardiometabolic lipid disorders. 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.

 

Established as a subsidiary of Ionis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense therapeutics. In July 2017, Akcea closed its initial public offering of common stock and is listed on the NASDAQ Global Select Market under the symbol “AKCA.”

ASSOCIATE DIRECTOR, DRUG PRODUCT MANUFACTURING

The Associate Director of Drug Product Manufacturing will be responsible for managing Akcea’s drug product manufacturing and packaging activities for volanesorsen, including supporting the global product launch.  This individual will be accountable for managing the relationships with suppliers that are providing cGMP compliant clinical and commercial supplies to patients around the world.  In addition, the associate director of drug product manufacturing will be responsible for management of technical and documentation aspects of drug product manufacturing, including review and approval of vendor documents (MBRs, specifications, etc.) as well as the product design history file.

 

RESPONSIBILITIES

 

  • Lead the CMO relationships for commercial drug product manufacturing and packaging
  • 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
  • Work closely with the Ionis team to provide CMC support for regulatory filings including marketing authorization applications, clinical trial applications and questions from health authorities
  • Coordinate vendor submission aspects of product annual updates to regulatory filings
  • Measure performance of CMOs through implementation and trending of key performance indicators and generate improvements plans as needed
  • Present as “Person-in-Plant” during drug product manufacturing and packaging runs
  • Provide CMC input and support to program teams
  • Coordinate of sample shipments (ID tests, release testing, stability, etc.) as necessary to support drug product QP release.  May also include coordination of registration samples to various health authorities
  • Maintain “inspection- readiness” of product Design History File

TECHNICAL QUALIFICATIONS

  • BS / BA in biological sciences, engineering, manufacturing, or science related field plus at least 7-10 years of relevant cGMP drug product manufacturing experience
  • 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

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%)

 

Excellent salary and benefits package offered.

For more information on Akcea and to apply for this position, please visit our website, www.akceatx.com.  Reference Requisition #16-0107

 

  NO PHONE CALLS PLEASE.  PRINCIPALS ONLY.

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