This role offers a unique opportunity to excel as a project manager in biopharmaceutical manufacturing. In this position, you will be responsible for ensuring the successful execution of capital investment initiatives within a commercial mammalian cell production environment.
The ideal candidate will possess a strong understanding of GMP regulations and biopharmaceutical manufacturing processes, as well as proficient project management skills. They will serve as the main point of contact among operational teams, quality assurance, and the Engineering team responsible for overseeing the Engineering, Procurement, and Construction Management (EPCM) contractor.
Key Responsibilities
* Project Scope & Strategy Development: Establish technical specifications and success criteria for projects, ensuring they align with GMP standards, operational objectives, and compliance requirements. Collaborate with stakeholders to incorporate operational enhancements into the project plan. Create a detailed roadmap for the project lifecycle, from initial design through performance qualification.
* Technical Leadership: Serve as the primary technical representative for projects, ensuring mechanical modifications and operational enhancements adhere to required specifications. Coordinate with EPCM teams to align engineering deliverables with technical and operational needs. Offer guidance and support to production personnel in implementing operational improvements.
* Quality and Compliance Oversight: Ensure that all project activities adhere to GMP regulations and internal quality standards. Work with QA teams to manage GMP change control processes, including the preparation, review, and approval of Technical Change Requests (TCRs) and Change Records (CRs).
* Cross-Functional Coordination: Communicate with operations, maintenance, engineering, and quality teams to ensure seamless integration of mechanical modifications into production. Facilitate communication and alignment between production staff and the EPCM to resolve any technical issues or deviations.
* Project Execution and Monitoring: Track the progress of technical and operational activities to guarantee milestones are achieved on schedule and within budget. Perform risk assessments and develop mitigation strategies for potential project obstacles. Provide regular updates and technical reports to project stakeholders.
* Testing and Qualification: Lead the planning and execution of equipment commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities. Oversee and collaborate with validation teams to ensure the effectiveness and reliability of implemented changes.
Candidate Profile
The ideal candidate for this position should have a Bachelor's or Master's degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related discipline. They must have over 5 years of experience in biopharmaceutical manufacturing, focusing on technical project management or operational excellence.
A strong understanding of GMP regulations and biopharmaceutical manufacturing processes is essential, as is proficiency in project management tools and methodologies. The ideal candidate will also possess excellent problem-solving abilities, strong communication and interpersonal skills, and the capacity to navigate technical challenges in a fast-paced setting.