Manager Combination Product Development
Insmed Incorporated

Job Info

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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 two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.

Overview

The primary function of this position is to support manufacturing operations by analyzing data and initiating Manufacturing investigations, deviations and change controls and developing actions to improve process robustness and product quality related to device development and combination product development. This position reports directly to Director, Combination Product Development This is a non-supervisory position Location: Hybrid (mix of work from home/corporate office - 1 or more days a week)

Responsibilities

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

• Generate process, product, and life cycle related metrics through statistical analysis
• Participate in Management Review as related to combination products quality metrics
• Review PQC monthly metrics
• Risk assessment/Analysis/ Risk management file including annual review of UFMEA
• Perform technical assessment to update Design history file for any design or process changes
• Lead complaint trend investigations involving combination product and/or device
• Lead Manufacturing investigations involving combination product and/or device
• Point of contact for the Device manufacturer including organizing regular technical meetings with Device Manufacturer
• Draft NDA amendments for any major changes
• Perform device changes technical assessment and own the change control process for the change
• Perform technical Review of any labeling, IFU and training material changes.
• Representative in CMC meeting responsible to assess device and combination product impact
• Work with cross functional team members effectively

Qualifications

Education and Experience

• Minimum 5 years of Engineering/Operations experience
• Bachelor's degree in engineering or science required
• Certified Quality Engineer or similar preferred

Required/Preferred skills

• Design Control and Risk Management experience required
• Statistical expertise preferred (Minitab or other statistical tools experience)
• CAPA lifecycle experience, including root cause investigation including Root cause analysis (RCA) techniques required
• Change Control experience required

• Working knowledge of FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, ISO 14971:2007, EU Medical Device Regulation is required
• Must have excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Travel Requirements

5 to 10% Domestic/International Travel

Salary Range

Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.

The base salary range for this job is from $111,000.00 to $156,133.00 per 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
• Competitive compensation package including bonus.
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan with company match
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day).

ADDITIONAL U.S. BENEFITS:

• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer

#LI-KM

#LI-Hybrid

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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 until the position is filled.

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