Description:
Note:
Fully remote but must be comfortable working PST standard business hours

Job Details: 

• The Project Manager will work in the Biosimilars Business Unit PD/Operation group, responsible for analytical similarity sample management of biosimilar programs to commercialization.
• Manages/optimizes routine workflows to support technical teams responsible for developing biosimilar candidates through to regulatory approval. Regularly interacts with management and cross-functional contacts.
• Skills: strong analytical skills; strong MS Word and MS Excel skills; knowledge of good data practices/data verification, understanding of systems for sharing and collaboration; excellent communication skills.

Responsibilities

• Provide project management to technical teams responsible for developing biosimilar candidates through to regulatory approval
• 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.
• Manage logistics for distribution of samples for testing and communicate incoming data for biosimilar projects.
• Create electronic laboratory notebooks (ELN) for sample submission.
• Generate lot number, sample ID, and retrieving data 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 Data Management
• Document archival in controlled document repository
• Provide data verification as needed for internal documents and regulatory filings in controlled document system.
• Utilize a strong foundation in scientific principles to thoroughly review regulatory documents and accurately determine the data elements that require verification in accordance with established protocols.
• Collaborate with cross-functional teams to ensure the completion and accuracy of the data verification processes.
• Assist in formatting documents in compliance with internal style guidelines and standards.

Basic Qualifications    

• Doctorate degree OR Master degree and 2 years of experience OR Bachelor degree and 4 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Top 3 Must Have Skill Sets:        

• Strong communication skills
• Attention to detail/meticulousness
• Scientific background (degree must be in scientific field) / experience working in a lab is also great. The scientific portion is more important then a PM background
• Knowledge of Microsoft applications (especially excel and word)
• Ability to work under minimal direction once trained (takes initiative)
• Strong time management
• Experience working with data

Pay Rate- between $65 - $74/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"