Project Coordinator

The Project Coordinator uses scientific and professional knowledge/experience in accordance with regulatory requirements to lead projects from start to completion. The Project Coordinator manages the required activities to meet client’s requirements in term of timelines, deliverables, and budget.

The Project Coordinator interacts with other departments’ heads to ensure that the required resources are available for completion of the project. She/He may coordinate portions of projects managed by other project managers. She/He provides project updates to peers and clients in a timely and efficient manner.

Duties and Responsibilities

• Accountable for the management of small to mid size projects or portions of big projects for clinical phase biologic or vaccine candidates.
• Coordinate between cross-functional teams from multiple disciplines including process and analytical development, GMP manufacturing, quality control testing, quality assurance and operations support.
• Engaging and coordinating external resource such as subcontractors or collaborators.
• Communicate with clients as instructed by project technical lead and/or project manager·
• Coordinate activities including:
• Process development experimental design.
• Manufacturing process design.
• Equipment selection, procurement, and validation.
• Manufacturing documentation preparation.
• Analytical development strategy development.
• Development of Quality Control Release and Stability Plans.
• Coordinate, monitor, and oversee projects from initial proposal phases, through detailed planning, execution, completion and close-out/handover phases.
• Identify issues and recommend improvements to project technical leaders and project management team.
• Ensure controlled and/or regulated project documents and records are initiated, advanced, completed and maintained in accordance with Biodextris’ Quality Management System (QMS) and relevant regulatory guidelines, including Good Manufacturing Practices (GMP).
• Ensure appropriate supporting documentation is provided for regulatory submissions.
• Ensure projects are executed in adherence to contract, budget, scope, schedule, and quality requirements.
• Engage and manage subcontractors and out-sourcing vendors as required.
• Coordinate project teams and document meetings agendas and outputs, actions, risks, issues, and decisions.
• Develop and communicate regular project status updates related to progress, timelines, changes, technical and/or quality issues to colleagues, management, and the client/sponsor.
• Coordinate resource assignments and scheduling with functional management.
• Coordinate with finance and accounting functions to ensure invoicing is aligned with performance deliverables.
• Facilitate study-related communications between scientists and corresponding client teams.
• Create and update project plans using appropriate digital tools for scheduling and facilitating project meetings, reporting, and invoicing.
• Exercise sound fiscal judgment concerning project profitability, reporting/monitoring of direct costs, and monthly invoicing.
• Implement scope change and communication process to inform all stakeholders of the related impact on time and budget.
• Practice safe work habits and adheres to company safety procedures and guidelines.

The above information has been designed to indicate the general nature and level of work performed by employees within these qualifications. It is not designed to contain or be interpreted as comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Qualifications

• B.Sc or equivalent in Bioprocessing related field; Biochemical Engineering, Chemical Engineering, Biochemistry or Microbiology or equivalent with 5+ years relevant experience.
• M.Sc or equivalent in Bioprocessing related field; Biochemical Engineering, Chemical Engineering, Biochemistry or Microbiology or equivalent with 2+ years relevant experience.
• Project Management Certification or Business degree with 5+ years relevant experience in industrial biopharmaceutical or life-sciences organizations.
• Demonstrated expertise with biologic (large molecule) manufacturing technologies, including cell banking, microbial/mammalian culture technologies, downstream purification methods, and product formulation for various delivery route(s).
• Demonstrated experience in leading projects in compliance with cGMP requirements, ICH guidelines, USP requirements, FDA and EC guidance.
• Demonstrated knowledge of biologic (large molecule) analytical technologies.
• Ability to work independently and flexibly and to adapt to changing priorities.
• Ability to work well with cross-functional teams and diverse groups of stakeholders.
• Knowledge of standard office software, i.e., MS Office.
• Effective written and oral communication skills as well as presentation skills