Senior Manager, Manufacturing Sciences & Technology

About the role

The Senior Manager, Manufacturing Sciences & Technology leads the manufacturing science strategy for a high‑volume commercial small‑molecule product. You will drive process robustness, in‑process control, and analytical alignment for a product with a complex coating and challenging dissolution profile.

Key responsibilities

• Lead execution of PPQ studies for new scales, suites, and process improvements.
• Own manufacturing investigations, change controls, and continuous process verification across a high‑throughput commercial program.
• Focus on coating uniformity, dissolution performance, and commercial‑scale process capability.
• Author technical content for regulatory submissions (NDAs, CBE‑30s, annual reports, international filings).
• Collaborate with Supply Chain and Commercial Operations on production timing and capacity planning.

Required profile

• Extensive experience in pharmaceutical manufacturing science, especially coating and dissolution.
• Proven track record managing large‑scale commercial manufacturing programs.
• Strong understanding of regulatory requirements and documentation.
• Ability to lead cross‑functional teams and drive continuous improvement.

Required skills

• Process development and scale‑up for coated solid‑dose products.
• Dissolution testing and analytical method alignment.
• Change control and continuous process verification (CPV) practices.
• Regulatory submission preparation (NDAs, CBE‑30s, annual reports).

What we offer

• Competitive compensation package with health and insurance benefits.
• Training and professional development opportunities.
• Performance‑based bonus eligibility.
• Dynamic, innovative work environment that values diversity.