Description:

• 100% remote Preferring either west or east coast.
• Duration: 1 year with possibility of extension

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 (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:        

• Strong project management skills
• Effective written and verbal communication
• Experience developing raw material specifications (non-lab based)
• Knowledge of GMP-controlled document systems
• Proficiency with ERP platforms, particularly SAP

Pay Rate  between $40 - $45/Hr on W2 based on experience.
 
"This posting is for Contingent Worker, not an FTE"