The Project Manager will work in the Biosimilars Business Unit PD/Operation group, responsible for analytical similarity sample management of biosimilar programs to commercialization.
- Provide project management to technical teams responsible for developing biosimilar candidates through to regulatory approval
- Assist with process development initiatives to meet internal needs
- Maintain awareness of regulatory environment and keep abreast of regulatory requirements that affect work projects
- Provide project management of biosimilar business unit (BBU) analytical similarity sample management.
- Collaborate closely with cross-functional team including Similarity Team, Critical Regents Group (CRG), Data Management, and scientific staff to plan and maintain inventory.
- Coordinate distribution of samples for testing and communicate incoming data for biosimilar projects.
- Lead cross-functional bi-weekly sample management meeting with BBU PD and CRG.
- Provide forecast to assist in sample and resource planning regularly.
- Create electronic laboratory notebooks (ELN) for sample submission.
- Generate lot number, sample ID, retrieving data and occasionally data entry and data authorization in QC LIMS.
- Assist BBU staff with navigating ELN software and placing work orders for ELN updates. Database queries of LIMS, ELN and other databases including the compiling and organizing data to review, verify independently or in coordination with Data Management.
- Retrieving and organizing data for review with Similarity Team and Data Management
- Contributing to internal presentations, INDs, Marketing Applications and authoring of analytical biosimilar quarterly updates.
- Provide data verification as needed for internal documents and regulatory filings in controlled document system.
Master's Degree and at least 3 years relevant experience
Bachelor's Degree and 5 years relevant experience
Associate's degree and 10 years of relevant experience
High school diploma / GED and 12 years of relevant experience
Bachelor's or Master's degree in life science, statistics, biostatistics, and/or computer sciences.
Excellent project management skills
Excellent oral and written communication skills
Lab experience in a biotech company
Experience in the development of biosimilar candidates
Technical writing experience or experience working on regulatory documents (INDs or marketing applications, etc.)
Good knowledge and experience with time management and timeline development
Pays attention to detail