Direct Materials Sciences Specialist/Expert
$93,900–$174,500 year
On-siteOceanside, California, United States
Job Summary
Lead material science solutions across PT manufacturing and distribution networks by implementing material-driven strategies aligned with internal and external regulations. Assess manufacturing process performance at a portfolio level to drive strategic improvements in robustness, speed, efficiency, safety, and sustainability. Represent the group as the technical lead to external stakeholders for supplier audits and technical visits while participating in cross-functional teams for network standardization. Manage key projects on technical material lifecycle, single-use technology implementation, and new material introductions. Collaborate with site and global functions to identify fit-for-purpose materials and alternate suppliers, ensuring regulatory compliance through active participation in deviation triages and CAPAs.
Required Qualifications
- BS/MS/PhD (preferably in Science or Engineering-related fields)
- at least 4 years of experience in the pharmaceutical, biopharmaceutical, or medical device industry
- Expertise in raw materials, including material science, critical attribute assessments, and specifications
- strong track record in pharmaceutical manufacturing, focusing on drug product manufacturing
- Demonstrated project management skills
- working knowledge of ICH guidelines
- working knowledge of GMP operations
- working knowledge of health authority regulations
- Ability to interpret and apply Roche Quality standards
- Strong quality mindset
- meticulous attention to detail
- commitment to service excellence
- <10% of travel required
Desired Qualifications
- Strong background in designing, implementing, and using single-use materials for drug product aseptic filling
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.