Manager, Combination Product Development

Posted on Sep 15, 2024 by Insmed Incorporated
Bridgewater, NJ
Admin & Secretarial
Immediate Start
Annual Salary
Full-Time
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 Manager, Combination Product Development is to support design and development activities for new combination products.

Responsibilities:

Generate process, product, and life cycle related metrics through statistical analysis

Risk assessment/Analysis/ Risk management file including annual review of UFMEA

Generate design history file for new products

Study design and coordination of characterization studies

Work with cross functional team to develop user requirements and design inputs

Lead complaint investigations involving combination product and/or device

Point of contact for the Device manufacturer including organizing regular technical meetings with Device Manufacturer

Draft IND submissions for the combination product

Perform device changes technical assessment and own the change control process for the change

Schedule and coordinate the design reviews

Project planning for the combination product development activities

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

Education and Experience:Minimum 5 years of Engineering/Operations/new product development experience

Bachelor’s degree in engineering or science

Certified Quality Engineer or similar preferred

Required/Preferred Skills:Design Control and Risk Management experience required

Combination product development experience preferred

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

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:

(phone number removed)

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

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  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.

Reference: 199991623

https://jobs.careeraddict.com/post/95321880

Manager, Combination Product Development

Posted on Sep 15, 2024 by Insmed Incorporated

Bridgewater, NJ
Admin & Secretarial
Immediate Start
Annual Salary
Full-Time
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 Manager, Combination Product Development is to support design and development activities for new combination products.

Responsibilities:

Generate process, product, and life cycle related metrics through statistical analysis

Risk assessment/Analysis/ Risk management file including annual review of UFMEA

Generate design history file for new products

Study design and coordination of characterization studies

Work with cross functional team to develop user requirements and design inputs

Lead complaint investigations involving combination product and/or device

Point of contact for the Device manufacturer including organizing regular technical meetings with Device Manufacturer

Draft IND submissions for the combination product

Perform device changes technical assessment and own the change control process for the change

Schedule and coordinate the design reviews

Project planning for the combination product development activities

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

Education and Experience:Minimum 5 years of Engineering/Operations/new product development experience

Bachelor’s degree in engineering or science

Certified Quality Engineer or similar preferred

Required/Preferred Skills:Design Control and Risk Management experience required

Combination product development experience preferred

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

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:

(phone number removed)

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

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  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.

Reference: 199991623

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