Senior MS&T Manager, Pharma (Coating & Dissolution)

Pharmaceutical Compliance Forum Inc; Cary, Northern (NC, KY); Hybrid; USD 160,000 - 175,000; Full time

Job summary

Pharmaceutical Compliance Forum Inc in Cary, NC seeks a Senior Manager, Manufacturing Sciences & Technology (MS&T) to lead the manufacturing science strategy for a high-volume commercial small molecule program, including coating and dissolution-focused process robustness.

You will own PPQ studies, CPV collection, change controls, and regulatory submissions, while mentoring engineers and coordinating with CDMO partners to sustain a busy manufacturing calendar.

Qualifications

• 10+ years pharmaceutical/biotech manufacturing experience.
• Experience with film-coated, modified-release solid dosage forms and dissolution testing.
• Experience supporting a high-volume commercial manufacturing program and regulatory submissions.
• Mentor and develop junior technical staff in a global network.

Responsibilities

• Lead MS&T product lifecycle for a high-volume commercial program (100+ batches/year).
• Own PPQ studies for new scales, suites, and process improvements entering the network.
• Own CPV strategy, data trending, and dissolution-related process parameters.
• Lead investigations, deviations, CAPAs, and change controls; troubleshoot complex issues.
• Author regulatory submissions and support inspections and audits.

Skills

Process validation

CPV

PPQ

Coating science

Dissolution testing

Change controls

Technology transfer

Regulatory submissions

Leadership

Mentoring

Education

Bachelor's degree in Engineering/Pharma

MS/PhD/MBA preferred

Job description

Pharmaceutical Compliance Forum Inc in Cary, NC seeks a Senior Manager, Manufacturing Sciences & Technology (MS&T) to lead the manufacturing science strategy for a high-volume commercial small molecule program, including coating and dissolution-focused process robustness.

You will own PPQ studies, CPV collection, change controls, and regulatory submissions, while mentoring engineers and coordinating with CDMO partners to sustain a busy manufacturing calendar.