Technical Specialist Raw Materials-Remote (JP9656)
Cambridge, Massachusetts · Biotech/Pharmaceutical
Job Title: Technical Specialist Raw Materials-Remote (JP9656) Location:Cambridge, Massachusetts, 02138 Employment Type: Contract Duration: 12 months with likely extensions Job posting date: 1/13/2022 Note: Remote, Candidate to start sooner than 2/7/22
3 Key Consulting is hiring a Technical Specialist Raw Materials-Remote for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Manage the development and implementation of clinical and commercial raw material specifications, material master data, and other specification related documents.
Have an understanding and knowledge of the raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins).
Understand and develop the strategy for functionally equivalent materials for inclusion on production BOMs and material master data setup
Interface cross-functionally within the (with Process Development, Quality, Supply Chain and other GMP functions)
Other responsibilities include Quality System record ownership including change control, master data change control, deviation, and CAPA.
Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering).
Own Material Specification activities:
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
Generate meeting minutes/action items to partners to ensure completion of tasks
Own Master Data onboarding activities
Create and own Master Data Changes in Trackwise
Determine master data strategy for inclusion on BOMs
Ensure Animal Derived Material tissue and origin correctly identified in SAP
Manage material creation workflows by ensuring SAP data agents complete all tasks on time to meet onboarding need-by date
Coordinate with site warehouse, purchasing and accounting teams
Ensure material status is updated for use at manufacturing sites
Top Must have Skill Sets:
Knowledge of Raw Materials
Work in a fast paced environment
Quality control background
Degree in science background (biology & chemistry); PHD with little to no experience will qualified
Author Raw Material Specifications
Lead cross-functional specification development meetings
Manage master data change control
No experience with raw materials
No experience authoring documents
No experience with Quality Systems
Interview Process: Phone and Video phone
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.