Position Overview

Oversee management of all areas of Manufacturing to produce products and direct activities, so that approved products are manufactured on-schedule and within quality and cost standards. Job duties:
  • Develop manufacturing plan and establish procedures for maintaining high standards of manufacturing operations to ensure products conform to established quality standards.
  • Hire, train, develop and evaluate staff.
  • Identify, recommend and implement changes to improve productivity and to reduce cost and scrap.
  • Keep current on information and technology affecting functional areas to increase innovation and ensure facility regulatory compliance.
  • Assist senior staff members in the development and formulation of long- and short-range planning, policies, programs and objectives.
  • Initiate and coordinate major projects e.g. Plant layout changes, installation of capital equipment, etc.
  • Responsible for the introduction of products and for transfers from R&D and other sites.
  • Validate products to ensure commercial viability in accordance with regulatory requirements.
  • Bridge the focus areas of R&D, Quality, EHS, Production, Supply Chain and Engineering to create common understanding and objectives and ensure robust products and flawless manufacturing.
  • Oversee manufacturing of primarily chemistry-based products including synthesis, purification, filling/packaging, and quality control analytical testing.
  • Develop new manufacturing and synthesis technologies to improve yields and product consistency.
  • Perform additional duties as assigned.

    1. Bachelor's degree in Engineering (Chemical, Industrial, Pharmaceutical, Mechanical, or Materials Science), or any related science degree required.
    2. Minimum ten (10) years of experience in medical device (combination product experience strongly preferred), pharmaceutical, or biopharma.
    3. Minimum five (5) years of experience in management.
    4. Excellent communication skills both verbal and written.
    5. Understanding of statistical software tools for design and analysis of experiments.
    Desired Qualifications
    1. Master's of Science or related PhD strongly preferred.
    2. Knowledge of OPEX principles and tools, and hands-on knowledge of R&D processes.
    3. Knowledge of regulatory, validation and documentation requirements for product development, commercial production and site transfers.
    4. Knowledge of clinical procedures in interventional neuroradiology or interventional oncology.