Raw Materials Engineer, MSAT
Avid Bioservices
Summary
The Raw Materials Engineer, MSAT provides day-to-day technical management, qualification, implementation, monitoring, and support of raw materials, consumables, and single-use components used across Avid's manufacturing processes. The role exists to ensure that materials are technically suitable, qualified, and ready to support technology transfers, engineering runs, PPQ campaigns, and commercial manufacturing.
Job description
Key Responsibilities
- Qualify and implement new raw materials, consumables, and single-use components with Supply Chain, QA, QC, and Manufacturing, so that materials are GMP-ready ahead of technology transfers, engineering runs, PPQ campaigns, and commercial production.
- Build qualification packages and technical assessments for assigned materials, so that material readiness is documented per cGMP requirements.
- Author and revise Raw Material Specifications with MSAT, QA, QC, and Supply Chain, collaborating with clients on material requirements, so that acceptance criteria stay aligned with process requirements, client requests and supplier capability.
- Serve as day-to-day technical contact for assigned suppliers, reviewing their documentation, change notifications, and performance data, so that supplier technical risk stays visible and documented.
- Engage clients directly by email on raw material topics, collaborating on BOM assessments and Raw Material Specifications with Program Management leading client meetings, so that client material requirements are captured in Avid documentation.
- Perform raw material gap and BOM assessments during technology transfer, so that implementation gaps are resolved before manufacturing needs the materials for production.
- Drive material readiness actions across PPQ campaigns, so that material issues do not delay PPQ execution.
- Assess supplier changes, material substitutions, specification revisions, and supply disruptions, so that approved changes are implemented with complete, inspection-ready documentation.
- Support material-related Quality Events, and CAPAs with Manufacturing, Supply Chain and Quality Assurance and Quality Control, so that material issues are resolved with minimal manufacturing impact.
- Manage assigned materials from onboarding through periodic review, requalification, and retirement, so that technical files and lifecycle records stay current.
Minimum Qualifications
- Bachelor's degree in Engineering, Biotechnology, Biology, Biochemistry, Pharmaceutical Sciences, or related field, or equivalent experience.
- 3 - 5 years of experience supporting biologics manufacturing, MSAT, process development, quality, supply chain, or manufacturing operations.
- A team player who can oversee a project from start to finish with little to no supervision.
- Understanding of GMP manufacturing environments and technical documentation expectations.
Preferred Qualifications
- Experience supporting raw material technical assessments, investigations, change controls, or material qualification activities, and ability to work cross-functionally across multiple program priorities.
- Experience with supplier management and supplier technical documentation.
- Experience with raw material specifications, single-use technologies, resins, filters, or consumables.
- New product introduction, technology transfer, PPQ support, or CDMO manufacturing experience.
- Experience with deviations, investigations, CAPAs, or manufacturing troubleshooting.
Requirements
- Bachelor's degree in Engineering, Biotechnology, Biology, Biochemistry, Pharmaceutical Sciences, or related field, or equivalent experience
- 3 - 5 years of experience supporting biologics manufacturing, MSAT, process development, quality, supply chain, or manufacturing operations
- A team player who can oversee a project from start to finish with little to no supervision
- Understanding of GMP manufacturing environments and technical documentation expectations
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401(k) matching
- Paid time off
- Performance-based bonuses
Company overview
Avid Bioservices is a leading contract development and manufacturing organization (CDMO) specializing in biologics derived from mammalian cell culture systems. Founded in 1993 and headquartered in Tustin, California, the company has over 30 years of experience in biologics manufacturing. Avid provides comprehensive process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. Their expertise spans from early-stage process development to full-scale commercial manufacturing, including cell line development, upstream and downstream optimization, analytical methods development, and regulatory submissions support. The company has produced more than 250 commercial batches and has five commercial products marketed in over 90 countries. With state-of-the-art facilities and a flawless quality track record maintained for over a decade, Avid Bioservices focuses on transforming the CDMO experience through personalized processes, unrivaled expertise, and exceptional quality standards. The company was recently acquired by GHO Capital Partners and Ampersand Capital Partners in a $1.1 billion transaction, positioning it for continued growth in the biologics manufacturing sector.