Manager, Contract Manufacturing

Insmed Inc

NJ

JOB DETAILS
SALARY
$124,000–$161,000 Per Year
SKILLS
Biotech and Pharmaceutical, Budget Management, CMOS, Change Control, Chemistry, Code of Federal Regulations, Communication Skills, Contract Management, Contract Manufacturing, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Disability Insurance, Disease, Documentation, Dosage Forms, Drug Development, Drug Manufacturing, Drug Products, Employee Assistance Plan, Establish Priorities, FDA (Food and Drug Administration), Financial Regulations, Forecasting, GMP (Good Manufacturing Practices), Healthcare Reimbursement, ICH Regulations, Insurance Regulations, Interpersonal Skills, Inventory Management, Life Insurance, Logistics, Maintain Compliance, Manufacturing, Manufacturing Management, Manufacturing Operations, Manufacturing Technology, Minitab, Outsourcing, Performance Management, Pharmacy, Presentation/Verbal Skills, Problem Solving Skills, Procurement Management, Procurement Planning, Production Control, Production Costing, Progress Reports, Project Planning, Psychiatry and Mental Health, Purchasing/Procurement, Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Requirements, Statistical Process Control, Stock Purchase Plans, Supply Chain, System Validation, Technical/Engineering Design, Time Management, User Interface/Experience (UI/UX), Willing to Travel, Writing Skills
LOCATION
NJ
POSTED
30+ days ago

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we're in. Are you?

 

About the Role:

We're looking for a Manager, Contract Manufacturing on the Logistics team to help us expand what's possible for patients with serious diseases. Reporting to the Director, Contract Manufacturing, you'll oversee outsourced production at Contract Manufacturing Organizations (CMOs) or third-party manufacturers (TPMs), ensuring on-time delivery, high quality, and cost-effective production of pharmaceutical drug substance, drug product, and primary packaging. Key responsibilities include managing CMO performance, driving quality compliance (GMP), and overseeing routine execution of manufacturing operations for pharmaceutical products.

 

What Youll Do:

In this role, you'll have the opportunity to oversee the routine execution of manufacturing operations, resolution of technical issues, as well as deviations and change controls for pharmaceutical products. You will collaborate with cross-functional teams, including, MS&T, Quality Assurance, Regulatory CMC, and CMOs to ensure robust and compliant production processes. You'll also:

  • CMO Oversight: Oversight of routine manufacturing and resolution of technical issues as well as supporting change controls and deviations
  • Documentation: Responsibility for commercial manufacturing related program documentation/tracking, i.e. MBRs, change controls, deviations, progress reports, PO and budget tracking, CMC supporting documentation, etc.
  • Cross-Functional Collaboration: Work closely with Supply Chain, Quality Assurance, Quality Control, Regulatory CMC, Finance, Procurement, Project Planning and CMO's to ensure uninterrupted supply of Pharmaceutical Product
  • Regulatory Compliance: Ensure all processes comply with FDA, EMA, and ICH guidelines for pharmaceutical manufacturing
  • Quality and Compliance: Collaborate with QA to ensure compliance with GMP, regulatory requirements, 21 CFR 212, and manage deviations/CAPA
  • Supply Chain Coordination: Coordinate with internal supply chain teams for forecasting, material procurement, and inventory management
  • Travel: Travel to vendor and manufacturing locations for support of manufacturing activities

 

Who You Are:

You have a Bachelor's degree along with 5 years of experience in pharmaceutical manufacturing, supply chain, or pharmaceutical development. You are or you also have:

  • Experience with commercial CMO operations
  • Strong background in Manufacturing of Oral Solid Dosage forms including spray drying, tableting, and encapsulation technology for pharmaceutical applications
  • Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals
  • Proven ability to identify, assess, and solve technical problems
  • Experience with GMP manufacturing, technology transfer, process scale-up, and validation
  • High energy, innovative "can do" attitude
  • Ability to work independently without the need for constant supervision
  • Strong interpersonal skills and the ability to work in a fast-paced, multidisciplinary environment
  • Strong verbal and written communication skills
  • Nice to have (but not required):
  • Advanced degree in Pharmacy, Chemistry, Engineering
  • Experience with inhaled powders, sterile manufacturing and blister primary packaging
  • Experience with Minitab

 

Where You'll Work

This is a hybrid role based out of our Bridgewater, NJ office. You'll have the option to work remotely most of the time, with in-person collaboration when it matters most.

 

Travel Requirements

This role requires occasional domestic travel (approximately 20%).

 

Pay Range

$124,000.00-161,000.00 Annual

 

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

 

Highlights of our U.S. offerings include:

  • Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
  • Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
  • 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
  • Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
  • Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

 

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. Current Insmed Employees: Please apply via the Jobs Hub in Workday.

 

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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.

 

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

 

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.

 

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.

 

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

 

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request: A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or An alternative selection process by emailing Privacy@insmed.com.

Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.

About the Company

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Insmed Inc