Irvine, CA

February 17, 2020

Location: Irvine, CA

Department: Laboratory Operations

Reports To: Sr. VP, Global Operations

FLSA Status: Exempt

 

 

 

JOB SUMMARY:

The Jr. Project Manager position is a growth position intended to develop the next leader of Agendia’s project management office. The incumbent will fill a key role in our company that requires the ability to influence and negotiate with internal and external stakeholders and to be accountable for the cross-functional projects from concept through product launch.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Under the direction of the Sr. PM, the incumbent will manage project deliverables: coordinate teams through project milestones and directly engage with/contribute to QMS-related documentation.
  • Identify and communicate issues proactively to cross-functional teams for product development as well as other high priority initiatives.
  • Create and coordinate integrated project/portfolio plans.
  • Lead and manage milestone review meetings, including creating agendas and keeping minutes and recommending actions and developing/managing detailed project plans including resource planning.
  • Help teams identify potential bottlenecks or delays and propose solutions.
  • Work and collaborate with teams to ensure the implementation of lean processes that meet regulatory and quality requirements.
  • Facilitate the exchange of information between departments on a day-to-day basis and maintains liaison with all members of the project team between project team meetings.
  • Responsible for continuous improvement of the product development process to streamline time to market.

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

CONTACTS:

Internal

  • Operations, RA/QA, commercial teams, billing, finance, medical affairs, clinical team, etc.

External

  • Clients, vendors, regulatory agencies, etc.

EDUCATION & EXPERIENCE REQUIREMENTS:

EDUCATION

  • Bachelors degree in life sciences or related field
  • An advanced degree in either business or a technical field is desired
  • Relevant experience of 4 to 7 years with BS/BA and 3-5 years with Masters degree
  • PMP or similar certification is highly desired

EXPERIENCE

  • Experience working in team environments is required. Knowledge of Program / Project Management tools such as project scheduling, work breakdown structures, time and cost reporting is required.
  • Experience leading core teams to successfully launch medical devices or in vitro diagnostic products is highly desired.
  • Experience with both Agile and Waterfall program management, PMP certification preferred.
  • Experience in an FDA/ regulated environment required.

Willingness to do up to 40% (domestic/international) business travel.

Certificates and License Requirements:

  • California Clinical Laboratory Scientist (CLS) or Clinical Genetic Molecular Biologist Scientist (CGMBS) License or any other specialist license that can perform high complexity molecular testing.

Skills and Qualifications Requirements:

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

  • Computer proficiency – MS Windows, MS Office, database experience
  • Ability to learn, develop and/or modify procedures for new processes and products
  • Strong analytical, critical thinking, and troubleshooting skills
  • Strong negotiation skills and supplier development experience
  • Ability to communicate effectively at all levels of the organization
  • Strong presentation skills to individuals or groups
  • Be able to work in an agile manner, ready to adapt, and respond to changes in process/project in a positive manner.
  • Results oriented, analytical thinking with strong problem-solving skills.
  • Ability to interact with executive leadership, highlight issues and provide options and solutions for resolution.
  • Ability to deal with ambiguity and resolve complex issues to action-based resolution plans.
  • Strong project management and meeting management skills capabilities.
  • Excellent verbal and written communication skills across all levels of an organization.
  • Detailed orientated with the ability to develop strategy
  • Extensive business knowledge with comprehensive understanding of the organization and functional area.
  • Position requires the ability to collect information from multiple sources, sort through, integrate, and resolve often conflicting requirements, and drive an organization through the various issues to result in a successful product launch

Supervisory Responsibilities:

  • This position requires no formal supervisory responsibilities.

Environment/Safety/Work Environment:

  • Establishes ADA (Americans with Disabilities Act) requirements

Physical Demands:

  • Regularly walks, stands, and sits
  • Regularly works on a computer for approximately 6-8 hours a day
  • Regularly works with pipettes (or other equipment)
  • Frequently lifts, pushes/pull, and carries up to 20 pounds
  • Exposed to extreme cold for typically 2 hours per month when assisting with removing samples from freezers or loading inventory
  • Exposed to hazardous materials (dry ice) on a monthly basis
  • Must follow lab safety practices when working in freezer or with hazardous materials including use of personal protective equipment such as: gloves, lab coats, and safety glasses
  • Must be able to read and understand scientific and complex directions