About the job
Position: Chemistry, Manufacturing, and Control (CMC) Manager
Location: 36 Columbia Rd., Morristown, NJ, USA, 07962
Contract Duration: 12+ Months
Job Overview:
The CMC Manager will play a pivotal role in supporting the Morristown Chemistry, Manufacturing, and Control Development (CMCD) team. This team is essential in providing technical guidance to ensure compliance in the development of Chemistry, Manufacturing, and Control (Module 3) technical documentation for our commercial products.
Your primary responsibility will be to prepare and maintain technical CMC registration documents to uphold our marketing authorization across various countries. This includes updates to existing dossiers, handling variations and renewals, responding to deficiency letters, and addressing compliance gaps.
Key Responsibilities:
- Draft and update technical registration dossiers (CTD Module III and QOS or equivalent) for pharmaceutical products.
- Assess change requests to define technical requirements in line with regulatory guidelines.
- Collaborate with manufacturing and contract sites to ensure timely compilation of high-quality CTD Module III documents.
- Manage Technical CMC dossier documentation related to change requests, including manufacturing site transfers.
- Coordinate with customers to align on regulatory strategies for maintenance activities.
- Stay updated on current industry standards and requirements for CTD Module III and post-approval activities.
- Represent the CMCD team in cross-functional project teams as needed.
- Prepare draft responses to technical-regulatory inquiries from health authorities, including expert statements and scientific justifications.
Qualifications:
- Bachelor's degree in a scientific discipline (e.g., chemistry, biology).
- Proficient in understanding technical reports, including stability, validation, and manufacturing documentation.
- Experience in authoring submissions, including variations, supplements, and annual reports.
- Knowledge of change controls and dossier maintenance processes.
- Demonstrated experience in post-approval product maintenance.
- Strong attention to detail and organizational skills.