CMC Data Management Specialist

CMC Data Management Specialist

Position Summary:

The CMC Data Management Specialist (Contractor) will be responsible for the organization and maintenance of CMC manufacturing database. The candidate will work closely with CMC leads to develop and implement the ideal data structure, organize complex and dispersed data sets, and build visualization tools to assist with CMC process development and cGMP manufacturing activities.

Responsibilities:

• Develop and implement data organization strategies ensuring high-quality, reliable, and analysis-ready data in support of CMC activities
• Partner with CMC functional leads to define data requirements
• Work directly with CMC team and external partners to collect data and documents
• Build visualization tools to support CMC process development and cGMP manufacturing activities
• Support CMC process data modeling activities

Qualifications:

• BS in relevant life sciences or engineering discipline with 1 years of Pharmaceutical/Biotechnology industry experience in process development of biologics, technology transfer, and/or cGMP manufacturing operations
• Broad familiarity with the full CMC landscape for biologics therapeutic protein production, spanning process development, technology transfer, regulatory and quality requirements, analytical development, formulation, and drug product technologies.
• Experience with building and organizing structured datasets and generating data visualizations
• Basic scripting (Python, VBA, etc.), understanding and proficient use of AI tools (OpenAI, Claude, etc.), data modeling experience is a plus
• Excellent communication and interpersonal skills in working across the organization and with external partners

Compensation

The anticipated hourly pay rate for this position is $65.00 - $80.00 This range represents a good-faith estimate of what The Company reasonably expects to pay for this position at the time of hire. Actual compensation will be determined based on factors including relevant experience, skills, qualifications, and internal equity. This position is also eligible for an annual target bonus and equity compensation as determined by the Company’s compensation committee.