Senior Manager, Manufacturing Science and Technology - Drug Product at PTC Therapeutics in Dublin

Job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team , fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: www.ptcbio.com Job Description Summary: The Senior Manager, Manufacturing Science and Technology – Drug Product, provides technical and operational support for manufacturing activities for commercial and late-stage clinical small molecule programs for the drug product including, but not limited to, formulation compounding, primary/secondary packaging, technology transfer, and process validation at contract manufacturing organizations (CMOs). This position supports process development, regulatory interactions/submissions, and clinical and commercial manufacturing. He/she also oversees early access and commercial label generation and release to ensure Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines. The Senior Manager, Manufacturing Science and Technology–Drug Product also acts as person-in-plant for the drug product manufacturers and assists in maintaining excellent supplier relationships and timely production schedules. The incumbent works cross-functionally with internal departments and external resources on Manufacturing Science and Technology related issues. The Senior Manager, Manufacturing Science and Technology - Drug Product supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Job Description: ESSENTIAL FUNCTIONS Primary duties/responsibilities: · Provides person-in-plant (PIP) technical support during manufacturing of drug product. Provides production troubleshooting including identifying any potential process, equipment performance and material issues. Travels to CMOs to monitor production of drug product; and interfaces with CMOs and internal departments to facilitate the manufacture and release of drug product. · Coordinates activities related to manufacturing, packaging, and labeling, ensuring adherence to GMP, GCP and ICH guidelines. "> ">undefined · Executes activities related to drug product technology transfer, validation and process improvements to manufacturing partners. · Supports process validation life cycle initiatives, including process performance qualification and continued process verification studies. Collaborates with Process Development in establishing risk assessments, process design/characterization, and process control strategies. · In collaboration with internal and external manufacturing teams, assists with troubleshooting or investigations related to manufacturing processes. Works with manufacturing and quality teams to author deviations, RCA, non-conformances, and CAPAs as required. Partners with Quality function(s) to address these issues efficiently, effectively, and compliantly. · Monitors existing vendors' activities. This includes, but is not limited to, reviewing vendor batch records, randomization files, label copies, variable text documentation, change orders, distribution procedures and invoices. "> ">undefined · Trains in policies, procedures and standards which impact the department, while working to ensure compliance with applicable regulatory requirements. "> ">undefined · Assists the authoring, reviewing, execution and issuance of drug product process development, registration and validation protocols and reports; supports the authoring and review of the manufacturing-related sections of regulatory submissions (domestic and international). "> ">undefined Executes experiments and studies in support of root cause investigations and product/process impact asses