Technical Specifications Specialist - Biotech (JP5950)
Thousand Oaks, CA
Contract - Part time, 20 hours a week average
Raw Materials - Specifications
Initial 6 months with likely extension
3Key Consulting Inc. is recruiting for a Technical Specifications Specialist with experience in development and implementation of clinical and commercial raw material specifications and other specification related documents., for a global CA-based bio-pharmaceutical company.
Please note that this is a part time position, 20 hours a week.
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 Amgen (with Process Development, Quality, Supply Chain and other GMP functions) and externally with Amgen raw material suppliers. Draft specifications based on raw material attributes, where they are used in the Amgen 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.
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
Must Have Skill Sets:
- Background in GMP operations and manufacturing processes.
- Strong technical background (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering.).
- Change Control owner (managing revisions to a specifications).
Gathering requirements, generating specifications and managing changes to active specs Supporting advancement of Single use systems in ATO, ASM, and ARI. Start with collecting information to generate raw material specification. Analyzing information to revise the specification. Owning change control record (documenting changes and specifications.) This person will be leading meetings with operations, quality and PD
Employee Value Proposition:
This has the potential to turn into a full-time role. This person would be working on the next new thing in biotech manufacturing with single use systems. Amgen is the leader in this domain. Will gain exposure to leading edge tools in generating specifications. Moving to PLM system (product life cycle management) new to this industry.
Looking for people coming from the technical world and not just knowledge of quality systems. Candidate does not have solid technical background through education or work experience.
30 minute phone interviews to in person interviews.
We invite qualified candidates to send your resume to firstname.lastname@example.org
If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the 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.