Associate Director, MS&T

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

 

Consistently Ranked Science’s Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

  

 

 

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

  

 

Overview

The Associate Director, MS&T will be responsible for the development, optimization, and scale-up of spray drying processes for pharmaceutical formulations. You will collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, regulatory CMC, and contract manufacturing organizations (CMOs), to ensure robust and compliant production processes.

Responsibilities

• CMO oversight: Real-time oversight of CMOs execution of technology transfer, optimization, and validation of manufacturing operations and manufacturing.
• Process Development & Optimization: Design, develop, and optimize spray drying and other drug product processes for pharmaceutical APIs and formulations.
• Scale-Up & Tech Transfer: Lead the transition of spray drying and other drug product processes from pilot and commercial scale to primary and secondary CMOs.
• Equipment & Operations: Troubleshoot spray drying and other drug product process equipment, ensuring efficiency and compliance with GMP regulations.
• Process Validation: Develop and complete validation protocols (IQ, OQ, PQ) for spray drying and other drug product processes. Prepare finalized spray dry formulation for product registration, validation, and commercial readiness.
• Cross-Functional Collaboration: Work closely with formulation scientists, manufacturing teams, and regulatory affairs to ensure smooth product development and commercialization.
• Regulatory Compliance: Ensure all processes align with FDA, EMA, and ICH guidelines for pharmaceutical manufacturing.
• Data Analysis & Reporting: Analyze process data, identify critical process parameters, and prepare technical reports for internal and regulatory submissions.

• Requirements:
• Minimum 7 years of experience in pharmaceutical process engineering, leading teams tasked with implementation of pharmaceutical manufacturing technology improvements within a regulated environment.
• Bachelor's degree in Chemical Engineering or equivalent field is required; an advance degree is preferred.
• Experience with commercial CMO operations.
• Strong background in spray drying technology for pharmaceutical applications; a background in capsule filling and blister primary packaging is a plus.
• Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals.
• Shown ability to identify, assess, and solve problems using root cause analysis methodology and document investigation and outcomes in a compliant manner.
• Familiarity with DOE (Design of Experiments) and statistical process control.
• Experience with GMP manufacturing, technology transfer, process scale-up, and validation.
• High energy, innovative “can do” attitude is required.
• Ability to work independently, remote from central leadership.
• Strong interpersonal skills and the ability to work in a fast paced, multidisciplin