Senior MS&T Lead: Coating & Dissolution

Asahi-Kasei; Cary (NC); On-site; USD 160,000 - 175,000; Full time

Job summary

Veloxis Pharmaceuticals, Inc. in Cary, NC is seeking a Senior Manager, Manufacturing Sciences & Technology to lead the product's lifecycle across scales, suites, and line extensions, with on-site support at a U.S.-based CDMO partner.

You will own CPV, investigations, change controls, and PPQ studies, mentor junior staff, and collaborate with Regulatory, QA, QC, Supply Chain, and Commercial Ops to enable high-volume manufacturing.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 10+ years of pharmaceutical/manufacturing experience.
• Experience with film-coated, modified-release solid dosage forms and dissolution testing.
• Experience supporting regulatory inspections and global regulatory submissions.

Responsibilities

• Lead MS&T product strategy across scales, suites, and extensions.
• Own CPV strategy, investigations, deviations, CAPAs and change controls.
• Author regulatory submissions and support inspections and audits.
• Mentor and develop junior scientists and engineers; promote learning.
• Collaborate with CDMO, QA, QC, Supply Chain and Regulatory Affairs.

Skills

Fluent English

Coaching and mentoring

Technical leadership

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, or related field

Advanced degree (MS, PhD, or MBA) strongly preferred

Job description

Veloxis Pharmaceuticals, Inc. in Cary, NC is seeking a Senior Manager, Manufacturing Sciences & Technology to lead the product's lifecycle across scales, suites, and line extensions, with on-site support at a U.S.-based CDMO partner.

You will own CPV, investigations, change controls, and PPQ studies, mentor junior staff, and collaborate with Regulatory, QA, QC, Supply Chain, and Commercial Ops to enable high-volume manufacturing.