Specialist, Quality CMC Operations
Insmed Incorporated
Summary
Reporting to the Sr. Director, Quality CMC, the Quality Specialist will play a key role in executing QA activities for Insmed supporting Phase 1-3 pipeline products. Specific areas of responsibility include Batch Record Review, Product Release process, CoA review, CoR generation, QA Metric monitoring, in addition to other QA related activities.
Job description
What You'll Do
In this role, you'll have the opportunity to perform batch disposition activities, including reviewing and approving batch records, certificates of analysis, and other relevant documentation for pipeline drug substance, drug product and medical devices. You'll also:
- Generate certificate of releases, create lots in electronic system and upload all required documents for internal and external stakeholders.
- Ensure compliance with all relevant regulations and guidelines related to pharmaceutical quality and batch disposition.
- Collaborate with cross-functional teams to resolve quality-related issues and ensure timely release of products.
- Drive continuous improvement initiatives to enhance the efficiency and effectiveness of quality assurance and batch disposition processes.
- Develop and maintain standard operating procedures (SOPs) for batch disposition and quality assurance processes.
- Communicate with external suppliers and internal stakeholders regarding quality-related matters.
- Maintain accurate and organized records of all quality assurance and batch disposition activities.
- Participate in cross-functional projects and provide quality assurance expertise and support, as needed.
- Partner with Quality CMC team members and colleagues in other departments to increase the overall effectiveness of the Quality Assurance department and build supportive, productive relationships.
Who You Are
You have a minimum of a Bachelor's degree in Chemistry, Life Science or related discipline as well as at least 3 years' experience working in a pharmaceutical company. You are or also have:
- Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
- Demonstrated experience working with an electronic document management system.
- Must be knowledgeable on cGMP's and other regulatory requirements applicable to GMP product manufacturing operation and release.
- Proven experience in batch records review and product release process.
- Demonstrate ability to manage projects and variable workloads.
- 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).
- Knowledge of Veeva Quality Vault system is highly desirable.
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/international travel (approximately up to 10%).
Requirements
- Minimum of a Bachelor's degree in Chemistry, Life Science or related discipline
- At least 3 years' experience working in a pharmaceutical company
- Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices
- Demonstrated experience working with an electronic document management system
- Must be knowledgeable on cGMP's and other regulatory requirements applicable to GMP product manufacturing operation and release
- Proven experience in batch records review and product release process
- Demonstrate ability to manage projects and variable workloads
- 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)
- Knowledge of Veeva Quality Vault system is highly desirable
Benefits
- Medical, Dental & Vision
- Mental health support
- Annual wellbeing reimbursement
- Employee Assistance Program
- Paid time off
- Fertility and family-forming benefits
- Caregiver support
- Flexible work schedules
- 401(k) plan
- Company match
- Annual equity awards
- Employee Stock Purchase Plan
- Life insurance
- Disability insurance
- LinkedIn Learning
- Skill building workshops
- Leadership programs
- Mentorship connections
Company overview
Insmed Incorporated is a people-first global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. Headquartered in Bridgewater, New Jersey, with offices and research locations throughout the United States, Europe, and Japan, the company focuses on delivering first- and best-in-class therapies for underserved patient communities. Insmed's portfolio includes two approved therapies for chronic lung diseases: ARIKAYCE for Mycobacterium avium complex lung disease and BRINSUPRI for non-cystic fibrosis bronchiectasis. The company is advancing a diverse pipeline of mid- to late-stage investigational medicines and cutting-edge drug discovery programs spanning gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue technologies. Recognized as the No. 1 Science Top Employer for five consecutive years, Insmed employs 1,001-5,000 professionals globally and maintains a strong commitment to innovation, patient-centricity, and corporate responsibility.