Senior Director, Commercial Manufacturing

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

Named Science's Top Employer in 2021, 2022, and 2023

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 were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for three 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.

Responsibilities

Reporting to the Executive Director, Supply Chain & Logistics, the Senior Director, Commercial Manufacturing will have responsibility for the commercial manufacturing of Insmed drug products.

This includes oversight of CMOs, improvement projects, and troubleshooting activities related to manufacturing processes as well as overall program deliverables (progress reports, CMC supporting documentation, budget tracking, etc.).

• This is a supervisory position (two direct / one in-direct report)
• This role oversees vendors and / or contractors

Additional representative responsibilities will include, but not necessarily be limited to, the following :

Responsible for the oversight of commercial manufacturing operations at CMOs. This includes improvement projects, troubleshooting activities and generally increasing robustness and reproducibility of manufacturing processes.

This is to be achieved by leveraging the process expertise within Insmed and our contract partners.

• Responsibility for commercial manufacturing related program documentation / tracking, i.e. MBRs, progress reports, budget tracking, CMC supporting documentation, etc.
• Additionally, as part of the company's overall drive to improve manufacturing quality the Director will be responsible to develop KPI's of department performance as measured by such metrics as success against manufacturing forecasts and manufacturing compliance (e.

g. rapid resolution of manufacturing deviations and implementation of CAPA's).

The Sr. Director will lead and manage a team of two direct reports and one indirect.

Qualifications :

• Bachelor's / Master's degree in Chemical Engineering or equivalent is required. Advanced degree is preferred
• Prior management of drug and / or device manufacturing
• 10+ years experience managing manufacturing processes (preferably of products marketed in the US, EU and Japan)
• 5+ years experience leading teams tasked with tech transfer and scaling up processes for product in US, EU, Japan
• 5+ years experience leading teams tasked with implementation of manufacturing technology improvements within a regulated environment
• Has a successful track record working both with small-scale start-up companies as well as with multi-nationals
• Experience with aseptic manufacturing, parenterals, inhalation, API, solid oral dosage, and / or medical device manufacturing is an advantage
• Experience working with CMOs is an advantage
• High energy, innovative

Travel Requirements

Up to 25% travel to domestic and international manufacturing sites

Salary Range

$207,000 - $289,867 a year

Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including :

• Flexible approach to where and how we work, regionally based
• Competitive compensation package including bonus
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break

ADDITIONAL U.S. BENEFITS :

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters

Additional Information

Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities.

To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.

com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis.

Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source.

Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities;

please contact us directly to be considered for a formal agreement.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.