Manager, Contract Manufacturing
About the role
We're seeking a Manager, Contract Manufacturing on the Logistics team to help 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.
Responsibilities
Oversee routine manufacturing and resolution of technical issues as well as supporting change controls and deviations
Collaborate with cross-functional teams, including MS&T, Quality Assurance, Regulatory CMC, and CMOs to ensure robust and compliant production processes
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
Requirements
Bachelor’s degree along with 5 years of experience in pharmaceutical manufacturing, supply chain, or pharmaceutical development
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
Strong interpersonal skills and the ability to work in a fast-paced, multidisciplinary environment
Strong verbal and written communication skills
Qualifications
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
Skills
Experience with commercial CMO operations
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
Strong interpersonal skills and the ability to work in a fast-paced, multidisciplinary environment
Strong verbal and written communication skills
Benefits
Life at Insmed offers 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 are also available. The 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 are additional benefits. Current Insmed Employees: Please apply via the Jobs Hub in Workday. 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.