Technical Specialist Raw Materials

Advanced Bio-Logic Solutions Corp; Thousand Oaks (CA); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company in the biotechnology industry is seeking a professional to manage clinical and commercial raw material specifications. This fully remote role involves detailed specification work, cross-functional collaboration, and compliance management. Ideal candidates will possess advanced degrees in life sciences or engineering along with substantial project management experience. Emphasis on experience related to GMP controlled documents and ERP systems is crucial for success in this role.

Qualifications

• Degree in Life Science or Engineering preferred.
• Industry and project management experience is a plus.
• Applications from advanced degree holders favored.

Responsibilities

• Manage development of raw material specifications and documentation.
• Interface with cross-functional teams and raw material suppliers.
• Act as change owner in Change Control Management System.

Skills

Project management experience

Knowledge of ERP Systems

Experience in GMP controlled documents management

Education

Doctorate degree

Master degree

Bachelor degree

Associate degree

High school diploma / GED

Tools

SAP

Job description

Description:

Exact Shift - remote role, 40hrs a week.

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.

Basic Qualifications
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

Top 3 Must Have Skill Sets:

• Project management experience
• Experience in GMP controlled documents management
• Knowledge of ERP Systems (SAP)

Pay Rate between $41 - $47hr on W2 based on experience.

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