Job Overview

We are seeking an accomplished Scientific Project Manager to play a crucial role in advancing our biosimilar programs through the commercialization process. This fully remote opportunity is designed for individuals who thrive in both independent and collaborative environments, contributing to a dedicated team committed to the success of biosimilar candidates. As a key figure in managing workflows, you will work alongside technical teams and oversee sample management to facilitate regulatory approvals.

Key Responsibilities

• Provide project management expertise to support the biosimilar business unit’s sample management and project workflows, collaborating effectively with cross-functional teams to enhance operational processes.
• Engage closely with the Similarity Team, Critical Reagents Group (CRG), Data Management, and other scientific personnel to strategically plan and uphold inventory.
• Manage the logistics of sample distribution for testing and convey test results within the biosimilar project teams.
• Develop electronic laboratory notebooks (ELN) for sample submissions, generating lot numbers and sample IDs, while retrieving data utilizing Quality Control Laboratory Information Management Systems (QC LIMS).
• Assist colleagues with ELN software usage, updating work orders, and supporting database queries, including data retrieval, organization, and verification.
• Archive documents in the controlled document repository and conduct data verification for internal documentation and regulatory submissions.
• Utilize your scientific expertise to meticulously review regulatory documents, ensuring accuracy and compliance with established protocols.
• Format documents to meet internal guidelines, ensuring uniformity and compliance across all documentation.
  
  

Required Skills

• Exceptional communication abilities and a keen eye for detail.
• A solid scientific background with a degree in a relevant scientific field (laboratory experience is a plus).
• Proficiency in Microsoft Excel and Word.
• A proactive approach to working independently following training.
• Superior time management skills with experience in data handling.
  
  

Qualifications

• Doctorate degree; OR
• Masters degree with a minimum of 2 years of relevant experience; OR
• Bachelors degree with at least 4 years of relevant experience; OR
• Associate degree with 10+ years of relevant experience; OR
• High school diploma/GED with 12+ years of relevant experience.
  
  

Career Growth Opportunities

This position offers a meaningful opportunity to significantly impact biosimilar development while fostering an environment that supports your professional growth and advancement as you acquire valuable project management and scientific skills.

Employment Type: Contractor