Technical Specialist Raw Materials

Dale WorkForce Solutions; Cambridge (MA); Remote; USD 70,000 - 110,000; Full time

Job summary

A leading workforce solutions provider is hiring for a remote documentation role focused on developing specifications for clinical and commercial raw materials. The ideal candidate will have a strong background in regulatory specification development and project management within a GMP-compliant setting. A Bachelor's or Master's degree is preferred, and strong communication skills are essential. This role is critical for supporting raw material documentation across global sites.

Qualifications

• 3 years of experience or 5 with a Bachelor's or 10 with an Associate degree or 12 with a high school diploma.
• Experience in documentation and regulatory specification development in a GMP-compliant environment.
• Laboratory experience preferred but not required.

Responsibilities

• Manage development and implementation of raw material specifications.
• Draft specifications based on raw material attributes.
• Interface with cross-functional teams and suppliers.

Skills

Degree in Life Science or Engineering

Knowledge of biologics and small molecules

Project management experience

Strong communication skills

Education

Doctorate degree

Master degree

Bachelor degree

Job description

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 Client (with Process Development, Quality, Supply Chain and other GMP functions) and externally with Client raw material suppliers. Draft specifications based on raw material attributes, where they are used in the Client 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.

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.

Basic Qualification

Doctorate degree or Master degree and 3 years of experience or Bachelor degree and 5 years of experience or Associate degree and 10 years of experience or high school diploma / GED and 12 years of experience