Careers

Infectious Disease Product Manager

Dept: Product Management
Reports To: VP, Product Development
FLSA Status: Non-exempt during the 90 day introductory period. Exempt after the introductory period and satisfactory completion of training requirements.


Summary

The Product Manager is responsible for driving the company’s strategy for reagents and platforms in the United States. They are responsible for assessing the market and competition, generating product requirements and specifications, managing the Product Development Process, pricing and product introduction activities. This position also includes traveling and telephone communication with industry leaders, customers, and partner companies.


Essential Duties & Responsibilities

  1. Analyze market for product potential
  2. Design market research projects to assess customer attitudes to the new product introductions
  3. Work with the Regulatory Department to contribute to the development of a regulatory strategy for product submissions to U.S. agencies
  4. Identify suitable initial and ongoing partners/customers
  5. Support the development and execution of Market and Product strategies and tactical plans
  6. Assist in the development, management, and execution of the product, technology and research portfolios
  7. Support concept development, market analysis, financial analysis and voice of customer for products
  8. Manage the Product Development Process for new products
  9. Assist in the development of clinical plans that support new products from initial phase to market release in partnership with Marketing Manager-Professional Relations and Strategic Marketing and the Clinical Department
  10. Assist in the development of clinical plans that support new products from initial phase to market release in partnership with Marketing Manager-Professional Relations and Strategic Marketing and the Clinical Department
  11. Foster relationships with key clinical individuals/organizations within the industry
  12. Performs other duties as assigned by Management
  13. Present product &technical information
  14. Recognize and communicate product issues, complaints, improvements and resolutions
  15. Attend conventions, sales meetings and training programs as required
  16. Communicate project status to company as required

Non-Essential Responsibilities

  1. Assist with service of equipment when needed
  2. Assist with validations/studies as needed

Qualifications

To perform this job successfully, and individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


Education/Experience

  • Must have a Bachelor of Science degree in biological science or a related field
  • Minimum of 2 years’ experience of clinical laboratory work
  • Marketing experience is preferred
  • Product management experience is preferred
  • Experience with the Investigational Device Exemption (IDE) process a plus
  • Ability to interpret and convey clinical data required
  • Independent thinking and a high level of initiative and the ability to interact well with physicians, customers, and key opinion leaders are essential.

Computer Skills

  • Proficient in Microsoft Word, Excel, PowerPoint, and Outlook
  • Internet Explorer, Chrome, or Firefox
  • Must be willing and able to learn other software programs as needed

Knowledge, Skills & Other Abilities

  1. Excellent analytical, strategic thinking and problem solving skills; strong verbal and written communication skills, and well-honed interpersonal and leadership skills are required
  2. Ability to present scientific and business information
  3. Knowledge of FDA Quality System Regulations (cGMP) and International Standards (ISO) pertaining to medical devices
  4. General Laboratory knowledge (use of equipment; pipetting; personal safety, general lab practices)
  5. Technical knowledge of clinical diagnostic testing procedures
  6. Basic knowledge of infectious disease serology
  7. Ability to communicate technical information and problems with customers and co-workers
  8. Ability to learn new & existing instrumentation and software technology
  9. Diplomacy and tact in resolving issues with customers and co-workers
  10. Ability to identify, solve, and coordinate resolutions to problems
  11. Ability to travel on short notice for periods of up to one week
  12. Must be able to coordinate own work travel arrangements
  13. Record data, make computations, analyze results, and write reports
  14. Spanish language skills a plus

Certificate & Licenses

  • Must maintain a valid driver’s license with a satisfactory driving record
  • Must maintain a valid passport for international travel

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.


Math Ability

Ability to work with mathematical concepts such as probability and statistical inference, apply concepts such as fractions, percentages, ratios, and proportions to practical situations. May need to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Must be able to determine test reliability and validity, analysis of variance, and correlation techniques.


Language Ability

Must have the ability to perform all of the following in English:

  • Ability to read and interpret documents such as safety rules, operation and maintenance instructions, and procedure manuals
  • Ability to write reports and business correspondence
  • Must be able to effectively present technical information and respond to questions from customers, and other employees of the organization

Equipment

  • General Laboratory Equipment (pipettes, scientific balances, volumetric glassware, etc.)
  • Incubators, shakers, 96-well plate readers, laboratory freezers and refrigerators
  • Gold Standard Diagnostics’ proprietary equipment
  • Computers, printers, and faxes

Physical Demands & Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee will regularly be required to stand for long periods of time; sit; walk; use hands; reach with hands and arms; talk; hear; and smell. The employee is occasionally required to stoop, kneel, crouch, or crawl, and may be required to lift up to 50 lbs. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus as well as see color. This position requires extensive travel.

In this position, the employee will be required to work in a team environment where the noise level is usually moderate. The employee is frequently exposed to work near moving mechanical parts, blood borne pathogens, and human serum. The employee is occasionally exposed to extreme cold (non-weather). The employee will be required to handle human specimens (whole blood, serum, plasma, urine, etc.) and may be exposed to toxic or caustic chemicals.

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