Project Manager

Position Summary & role expectations:

The Project Manager uses scientific and professional knowledge/experience in accordance with regulatory requirements to lead projects from start to completion. The Project Manager manages the required activities to meet client’s requirements in term of timelines, deliverables, and budget. The Project Manager interacts with other departments’ heads to ensure that the required resources are available for completion of the project. She/He provides project updates to clients in a timely and efficient manner.

Duties and Responsibilities:

• Accountable for the management of several projects for clinical phase biologic or vaccine candidates.
• Engage 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.
• Serve as primary liaison to the project client/sponsor for all technical, quality, logistical, and financial aspects of the projects.
• Manage and supervise 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.
• 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.
•  Facilitate 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.
• Facilitate study-related communications between scientists and corresponding client teams.
• Establish and optimize project plans using appropriate digital tools for scheduling and facilitating project meetings, reporting, and invoicing.
• Exercise sound fiscal judgment and coordinate with finance and accounting department 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.

ACKNOWLEDGEMENT AND AGREEMENT

Qualifications:

• B.Sc/M.Sc or equivalent in Bioprocessing related field; Biochemical Engineering, Chemical Engineering, Biochemistry or Microbiology or equivalent with 8+ years relevant experience.
• PhD or equivalent in Bioprocessing related field; Biochemical Engineering, Chemical Engineering, Biochemistry or Microbiology or equivalent with 5+ years relevant experience.
• Project Management (PMP or Scrum Master) 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