What are the responsibilities and job description for the LIMS/LabVantage Project Manager position at FUSTIS LLC?
Job Role: LIMS Project Manager
Location: Remote (MA candidates are highly preferred)
Pay Rate: $85-$95/hr. on C2C
Job Summary:
The client is seeking an experienced and highly skilled Technical Project Manager to oversee a high-visibility project related to the Certificate of Analysis (COA) processes. This individual will be instrumental in collaborating across multiple business units, including Global Quality, Resilience Sites, and INT (Individualized neoantigen therapies?), ensuring the successful execution of key project initiatives. The ideal candidate will have hands-on experience with LabVantage 8.7 and a solid understanding of master data management within the context of analytical testing and COA processes. This is an excellent opportunity to join a fast-paced environment at the forefront of innovation in biotech.
Key Responsibilities:
- Lead and manage a high-visibility project focused on improving and optimizing Certificate of Analysis (COA) processes across the organization.
- Collaborate cross-functionally with teams from Global Quality, Resilience Sites, and INT to gather requirements, drive alignment, and ensure project milestones are met.
- Oversee the implementation of improvements to LabVantage 8.7, with a focus on enhancing the COA process.
- Manage project timelines, resources, risks, and budgets, ensuring all project deliverables are achieved within scope and on time.
- Maintain effective communication with key stakeholders and ensure alignment on project goals, status updates, and timelines.
- Leverage your expertise in master data management to ensure data integrity and alignment with regulatory and quality standards.
- Facilitate meetings, discussions, and workshops to gather business requirements and drive consensus across various teams.
- Identify, track, and resolve project risks and issues, escalating when necessary to senior leadership.
- Ensure documentation and project deliverables are prepared and maintained according to regulatory and quality standards.
- Contribute to continuous improvement efforts within the COA process and related systems.
Basic Qualifications:
- Bachelor’s degree in a scientific or technical discipline (e.g., Life Sciences, Engineering, or related field).
- Minimum of 5 years of experience in technical project management, ideally in a biotech, pharmaceutical, or healthcare setting.
- Hands-on experience with LabVantage 8.7 or similar Laboratory Information Management Systems (LIMS).
- Strong understanding of master data management and its role in laboratory processes and COA generation.
- Proven ability to collaborate and communicate effectively with cross-functional teams, including Quality, Resilience, and Therapies units.
- Solid understanding of GxP (Good Practice) and regulatory requirements related to COA processes in the biotech/pharma industry.
- Excellent organizational, problem-solving, and multitasking skills.
- Strong verbal and written communication skills, with the ability to present complex ideas clearly to both technical and non-technical stakeholders.
Preferred Qualifications:
- Master’s degree in a relevant scientific or technical discipline.
- Experience in individualized therapies or similar highly specialized product areas.
- Familiarity with Agile project management methodologies.
- PMP (Project Management Professional) certification or similar project management credentials.
Salary : $85 - $95