Technical Specialist Raw Materials

Description: 100% remote Preferring either west of east coast. Duration: 1 year with possibility of extension The ideal candidate will have a strong background in documentation and regulatory specification development within a GMP-compliant environment. They should bring experience in project management and raw material specification, ideally from pharmaceutical, biotech, or similarly regulated industries (such as aerospace or chemical engineering). The role is fully remote and requires someone who can work independently with minimal supervision while contributing to regulatory filings and compliance efforts. Candidates with laboratory experience are often successful in this role, though no hands-on lab work is expected. A Bachelor’s or Master’s degree is preferred, and strong communication skills are essential. This is a high-impact documentation role critical to raw material support across global sites. Job Details: Manage the development and implementation of clinical and commercial raw material specifications and other specification related documents. Have an understanding and knowledge of raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins, Primary Containers). Interface cross-functionally within (with Process Development, Quality, Supply Chain and other GMP functions) and externally with raw material suppliers. Draft specifications based on raw material attributes, where they are used in the process and how they should be controlled. Facilitate specification development meetings and generate meeting minutes/action items to partners to ensure completion of tasks. Other responsibilities include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner. Skills: Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering); preference will be given to advance degree holders and/or those who have industry and project management experience. Responsibilities: 50/50 role split between Project Management and Specifications Management Perform specification management duties in support of year-over-year time reduction goals Report, analyze, and maintain departmental KPIs for performance tracking Support and potentially lead initiatives that improve departmental operations Apply tot his job