Associate Director, Manufacturing Sciences & Technology - Gene Therapy

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

Join the Technical Operations team as Associate Director of MSAT where you will support a growing pipeline of best-in-class viral vector gene therapy programs. At Insmed Gene Therapy you will be part of a collaborative team that works in a face paced and dynamic environment to bring viral vector gene therapies to market. Supporting our external manufacturing partners, you will be the process and data expert, working to further improve the process of manufacturing rAAV-based therapies. Working closely with Process Development and CMC teams, you will be the bridge between the laboratory and GMP manufacturing.

Responsibilities

• Works with management to plan and execute the MSAT department strategy for technology transfer from process development through to commercial manufacturing.
• Collaborate with external manufacturing partners, to execute facility fit assessments, tech transfer activities, coordination of process start-up activities including engineering runs, GMP/clinical, PPQ and routine commercial runs, and risk assessments.
• Builds and maintains technical relationships with CDMO partners.
• Serves as a key technical resource in support of manufacturing activities with active process monitoring and data trending, process deviation resolution, process improvements and scientific expertise in the manufacture of Drug Substance and Drug Product.
• Provides strong technical leadership to process engineers, scientists, and associates for clinical and commercial production.
• May represent Insmed Gene Therapy as subject matter expert for regulatory submissions and during regulatory compliance inspections.
• Travel will be required to support person-in-plant activities during production campaigns.
• Completes impact assessments for supplier change notifications and authors campaign summary reports.
• Will participate in planning activities for process characterization and PPQ planning activities.
• Review batch records, SOPs, raw material specifications, development reports and GMP protocols.
• Support the change control and the change management of process versions and process comparability assessments.

Requirements:

• 12 years of relevant experience with BS, 8 yrs with MS, or 5 yrs with PhD in Biotechnology, Chemical or Pharmaceutical Engineering, or related field alongside significant experience across bioprocess manufacturing.
• Broad experience in drug substance (upstream cell culture, downstream purification) as well as drug product.
• Experience leading and/or interacting with GMP manufacturing, process validation, and tech transfer teams.

Travel Requirements

This role can be remote-based.  Up to 30% travel domestically

Salary Range

$139,000 - $195,200 a year

Compensation & Benefits

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic loca