This person has the capability to work from a remote location within the United States, but their working hours must align with the Pacific Time Zone.

POSITION SUMMARY:

The Program Manager provides essential support in the coordination and execution of projects to launch new products or improve existing ones. The ideal candidate will have a strong understanding of medical device and in vitro diagnostic (IVD) design control processes, as well as familiarity with genetic testing using Next-Gen Sequencing. Additionally, the Program Manager plays a key role in facilitating communication among cross-functional teams, generating professional presentations, and maintaining meticulous project documentation. This role will primarily involve coordinating projects related to the development and implementation of IVD assays. This function is essential to ensuring teams define and achieve the objectives and goals required to complete projects on time and budget

PRIMARY RESPONSIBILITIES:

• Coordinate project activities related to the design, development, and implementation of new or existing products with a focus on Design Control and New Product Introduction in a technical setting

• Assist in the creation and maintenance of project timelines using tools such as MS PowerPoint and Smartsheet.

• Generate documents and presentations for project meetings and stakeholder communication.

• Collaborate with cross-functional teams (R&D, Engineering, Stats, QA/QR and Operations) to track project progress and milestones taking into account available resources, dependencies, priorities, risks and other constraints

• Organize and facilitate regular team meetings

• Maintain accurate project documentation and records.

• Provide support to other program managers and team members as required.

QUALIFICATIONS:

• Bachelor’s degree in Biology or a comparable educational background in science or engineering.

• Minimum of 3 years program management experience in biotech or related industry

• Certification or formal training in Program or Project Management is a plus

• MUST have familiarity with medical device and IVD design control and change management processes

KNOWLEDGE, SKILLS, AND ABILITIES:

• Proficiency in MS Office or Google applications (Word, Excel, PowerPoint, etc.).

• Experience using Smartsheet or similar project management tools for building and maintaining timelines.

• Strong attention to detail and organizational skills.

• Excellent communication and interpersonal skills with project teams and stakeholders, including senior management.

• Ability to work effectively in a cross-functional team environment.

• Proactive attitude and ability to multitask in a fast-paced environment.

• Ability to work independently and as part of team