Director, Program Management and Corporate Business Development

Organization
Focus Diagnostics
Job Location
Cypress, CA
Job Description

The position will direct and provide program management support for external projects, contract manufacturing, companion diagnostics partnerships and government contracts and grants working with both internal and external resources to ensure all key milestones are met.  The position will also provide relationship management for key partner companies such as Biogen Idec and 3M.

This position will direct and coordinate the Product Development Process (PDP) to institute core teams to implement Focus design control process for new products, from feasibility through manufacturing and post launch per Focus procedures.  This position will ensure proper validations of technical development processes and regulatory compliance through the core teams to ensure rapid flow of products from R&D into manufacturing.

This position will function as the program director and corporate liaison to the U.S. Government agencies.

 This position will also have responsibility for managing and growing our relationship and $20M annual revenue with Quest Diagnostics – the single largest customer for Focus.

Requirements

ESSENTIAL DUTIES & RESPONSIBILITIES

 

  • Responsible for running complex programs and projects which include handling tasks that are involved in design and development, as well as production.  Take an active role in new product identification and development.  Work closely with R&D to seek out and identify opportunities to expand product offering; Oversee the development of new diagnostic products.
  • Ensure that all projects follow the standard procedures that are used in the management and deployment of projects (PDP).  Ensure adherence to FDA regulations.
  • Responsible for planning and scheduling project goals, milestones and deliverables.  Define resources for project/program implementation, and determine requirements and plans for project life cycle deployment.
  • Oversee and guide all Design Control activities.
  • Act as the primary point of contact for communication between the U.S. Department of Defense and Focus Diagnostics.
  • Interact with 3M, as needed, concerning contract requirements pertaining to the integrated cycler.
  • Prepare and present quarterly internal government contract reviews with senior management and as required with the DoD.
  • As directed by senior management, lead the negotiations on any contract opportunities with DoD and/or other agencies within the U.S. Government.
  • Ensure Government contract compliance and maintain relationships with Government contracting agencies.
  • Act as the primary point of contact for communication between Quest Diagnostics and Focus Diagnostics in regards to product and service opportunities within Quest that can be fulfilled by Focus.
  • Develop relationships and meet with the senior Operational and Clinical Franchise stake holders at Quest Diagnostics to explore business opportunities and gain approval to adopt Focus Diagnostics’ products.
  • Build a strategic business plan to incorporate new testing from Focus into Quest Diagnostics.
  • Working collaboratively with internal Focus departments, provide coordination of product development, transfer cost development, and product integration within Quest Diagnostics for key products to be manufactured by Focus.
  • Incorporate project management tools and reporting formats to manage and monitor critical components of the Quest Diagnostics product integration strategy.
  • Meet with key operational leaders at Quest Diagnostics (reference laboratory sites) to monitor product performance.
  • Perform work within published expense and budget guidelines.
  • Perform other duties as assigned.
  • Travel – minimum 25%.

 

 

SUPERVISORY RESPONSIBILITIES

 

  • Responsible for the Program Management Office (PMO) which includes the management of 4-6 exempt employees including hiring, developing and performance management – including the writing of evaluations.

 

EDUCATION and/or EXPERIENCE

B.S. or B.A. degree.  MBA preferred.  Minimum of 10 years of business development and R&D program management experience in medical products – including 5+ years in the diagnostics industry, preferably in IVD products and equipment.  Experience in directly managing team of project managers as well as matrixed project teams.  Prior experience in contract management within the healthcare industry.  Strong working knowledge of Design Control.  Working knowledge of the U.S. Government’s purchasing and contracting organizations.  Working knowledge of key operations within a molecular diagnostics organization.  Must possess a proven track record for developing and sustaining strong customer relationships and successful contract negotiations. Working knowledge of the fundamentals of project 

How to Apply

Please visit our career page at www.questdiagnostics.com  click on job search and apply to position number: 3737506

About Our Organization

About Focus Diagnostics, Inc.A Leader in Diagnostic Testing

As part of the Quest Diagnostics family, Focus Diagnostics, Inc. is committed to providing proven and reliable products its customers have grown accustomed to throughout the years. Since its founding in 1978, Focus Diagnostics has grown its business from specialized laboratory testing to manufacturing its high-quality laboratory tests for hospitals and commercial laboratories worldwide. These manufactured tests are built in response to diagnostic testing trends identified and evaluated by Focus Diagnostics and used in Quest Diagnostics’ national laboratories.

Our product lines include the Simplexa™ molecular chemistries, HerpeSelect® HSV serology, and a line DxSelect™ IFA and ELISA assays. As an organization we strive to be the first company to provide diagnostic solutions for emerging infectious diseases, with past accomplishments including assays for West Nile Virus, SARS, and Influenza A H1N1 (2009).

Our Partnership with 3M™

Focus Diagnostics entered into an exclusive global distribution agreement with 3M in 2009 to bring the Simplexa™ molecular chemistries and 3M™ Integrated Cycler to the marketplace. These products were honored in 2011 with a Bronze-level Edison Award in the Science and Medical Diagnostic Aids category and received a Gold-level Medical Design Excellence Award (MDEA) in the In Vitro Diagnostics category.

Focus Diagnostics' Standard of Excellence

Today, Focus Diagnostics maintains its industry reputation as a market leader and is committed to providing products that accommodate your laboratory’s needs through reliable products, quality manufacturing practices and flexible solutions.

A research duo finds that science and technology graduate students who turn away from academic careers do so because of changes in their own interests.

Students whose classmates are interested in science are more likely to think about a career in science, technology, engineering, and mathematics, a new study says.

CNBC reports that the genetic counseling field is expected to grow as personalized medicine becomes more common.

Gladys Kong writes at Fortune that her STEM background has helped her as a CEO.