Sr. Project Coordinator, PD

About Us:

For 75 years, Fujirebio Diagnostics Inc., is a leading worldwide biotechnology Company and the innovation engine behind diagnostic breakthroughs that reach patients worldwide. Our in vitro diagnostics (IVD) technology powers critical tests across the globe’s leading diagnostic platforms.  We are a biomarker and diagnostic content provider that strengthens diagnostics for everyone. Through our approach of innovation, clinical evidence and global CDMO partnerships, we ensure that next-generation biomarkers are accessible across diagnostic platforms, so patients benefit no matter which system is used. 

Position Summary: 

The Sr. Project Coordinator will work within the Product Development environment to coordinate the accomplishment of strategic objectives and deliverables for new assay development; work with PD Project Managers and Internal/External stakeholders to coordinate activities associated with immunoassay development on automated platforms and transfer of technology to the manufacturing environment.

Essential Job Functions:

• Responsible for task coordination, activity alignment, timeline and resource management, and planning for Product Development projects.
• Collaborate with managers within Product Development, Analytical Development, Clinical Affairs, Regulatory Affairs, Quality/Regulatory Compliance, Logistics, and Operations to meet strategic development and transfer objectives.
• Assists in the development of technical documentation for Product Development activities as assigned including but not limited to: templates, deliverable documentation, study procedures, protocols and reports required for Concept and Feasibility Phases of development.
• Assists with the drafting of technical documentation required to support technical transfers and process validation activities.
• Responsible for scheduling, leading, and managing internal and external meetings including agenda, status updates, meeting minutes, and follow-up.
• Assists with the development and maintenance of stability data management templates (i.e. excel spreadsheets, JMP templates, etc.). Ensure consistency of data management and analysis practices for stability studies across all Product Development projects.
• Adheres to document timelines for document generation, revisions, and completion.
• Assists with document tracking and follow-ups to the various project and review teams.
• Follows all company environmental, health and safety policies, procedures and guidelines and conducts work in a safe manner. Manages junior coordinators and other staff as appropriate. Ensures a healthy balance of high morale exists amongst staff.
• Responsible for providing an environment which encourages the company's commitment to equal employment opportunity and the value of a diverse work force; other duties as assigned.

Job Specifications (skills, knowledge, special training, certification, license requirements):

• Knowledge of and experience with CLSI guidelines

• Demonstrated technical problem-solving skills and discipline

• Ability to write clear, concise technical reports

• Quality control experience desirable

• Excellent verbal and written communication skills

• Must be detail-oriented and thorough

• Excellent organizational skills

• Ability to work in a face-paced and dynamic environment

• Mastery of various project management software tools such as Smartsheet and Microsoft Project

• Ability to make presentations to various groups of individuals.

Education and Work Experience Required:

•      Masters or B.S. in Science/Engineering preferred

•      5-10 years of laboratory experience, preferably in the diagnostic or pharmaceutical industries

•      4-5 years project management experience preferred

•      Immunoassay development and manufacturing experience

The base salary range for this position is $97,000- $113,000/year.  The actual base pay offered may vary depending on multiple factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. The typical work schedule for this position is Monday to Thursday with half-day Fridays. 

We offer a competitive benefits package that starts on day one, including three medical plans, savings and spending accounts, employer-paid dental & vision, 401(k) match up to 6%, life insurance and disability, educational assistance, EAP, generous Paid Time-Off, paid holidays, and opportunity for advancement.

We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted.

Fujirebio Diagnostics is an Equal Employment Opportunity Employer

Salary : $97,000 - $113,000