Halozyme has completed its acquistion of Antares Pharma, creating a leading drug delivery business. View details here.
Antares Pharma: Making Medicines Feel Better

Senior Manufacturing Engineer

POSITION SUMMARY

The Senior Manufacturing Engineer will play a lead role in supporting the manufacturing requirements of commercially released products as well as products that are in various stages of development. This includes:

  • Leading simple to complex manufacturing projects by applying manufacturing engineering principles to achieve manufactural products and statistically capable processes
  • Converting device designs into process/equipment requirements, then into tooling/equipment concepts and prototypes, and finally, into commercial production
  • Working with external suppliers to deliver processes and/or equipment that meets the product/project requirements
  • Developing and managing detailed project timelines as applicable
  • Communicating and interacting with different levels of individuals within Antares as well within the supplier organizations
  • Considering regulatory requirements for device/drug combination products with the end goal of delivering final commercially released processes that can meet a high Overall Equipment Effectiveness (OEE) and quality requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to:

  • Develop manufacturing processes that are capable of achieving design requirements from laboratory through pilot line, into full scale manufacturing
  • Create and/or execute, as well as formally document, manufacturing process equipment validations consistent with Antares Pharma, Inc. requirements and standard operating procedures
  • Coordinating efforts to design, develop, and validate manufacturing processes using tools such as Design of Experiments (DOE), Measurement System Analysis (MSA), Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC), and capability analysis
  • Develop and/or communicate process/equipment specifications for process/equipment suppliers regarding quotes based on the product and customer requirements
  • Engaging and/or leading cross functional teams in Design for Manufacturability (DFM)
  • Create detailed project plans and manage the execution of assigned projects
  • Develop effective relationships (internally within Antares Pharma Inc. and with suppliers)
  • Communicate and manage through adversity-both internally within Antares Pharma Inc. and with suppliers
  • Work closely with a broad and diverse range of customers including pharmaceutical companies and process equipment suppliers to ensure that Antares Pharma Inc. manufacturing process/equipment requirements are meet, as well as to ensure a deep and current understanding of the customers/markets Antares serves
  • Bring forward and deploy best practices in manufacturing engineering excellence
  • Ensure integrate approach/process with device design, process/equipment suppliers, and other strategic partners in the business
  • Deliver results: support commercial manufacturing, support assigned product development projects from a manufacturing perspective, and take a lead role in striving to achieve manufactural products that have high quality and robust manufacturing processes in collaboration with Product Development / Quality / Suppliers

EDUCATIONAL REQUIREMENTS (DEGREES, LICENSES, CERTIFICATION)

  • Bachelor's degree in Engineering or technology related field required
  • Master’s Degree in Engineering or Business preferred
  • Six sigma black belt preferred

YEARS OF EXPERIENCE

  • 7-10 years previous medical device background
  • 7-10 years experience manufacturing process development including characterization, process optimization, validation, and ramping production for high-volume specifications in the medical device industry

OTHER SKILLS AND ABILITIES

  • Proven ability to write thorough technical protocols, plans, and reports
  • Ability to provide innovative solutions to complex problems
  • Excellent written and verbal communication skills
  • Experience creating and writing process/equipment IQ/OQ/PQ validations, including test method validations
  • Experience executing process/equipment IQ/OQ/PQ validations, and documenting such in written final technical reports
  • Experience working with a variety of assembly, plastic injection molding, and machining suppliers
  • Experience with equipment and tooling designs including machine specifications
  • Experience supporting/representing the manufacturability/manufacturing processes for commercially approved products; as well as products that are in various stages of product development but planned for future commercial release.
  • Ability to communicate vertically and horizontally through multiple channels, as well as vertically and horizontally with suppliers
  • Knowledge related to regulatory requirements for GMP
  • Experience managing and leading key manufacturing and/or engineering projects
  • Innovation and creativity desirable
  • A solid track record of completing successful manufacturing projects, on time and within budget is essential
  • Steeped in engineering and device process/product commercialization process improvement

Careers@Antarespharma.com

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