PTC Therapeutics, Inc.
Mgr, Analytical Development - Qualification & Validation (Creative Design)
The Manager, Analytical Development – Qualification and Validation contributes to the CMC team by collaborating with Subject Matter Experts (SMEs) to author or revise CMC-related documents. This includes, but may not be limited to, Standard Operating Procedures (SOPs), batch/lab records, qualification/validation protocols and report and development reports. This involves drafting new documents or reviewing/revising current documents, collecting and consolidating input from cross-functional stakeholders; and finalizing the documents. The incumbent is also responsible for applying appropriate document templates, standards, style and terminology across documents.
The incumbent works cross-functionally with internal departments and external resources on GxP-related procedural documents and reports, as appropriate.
The Manager, Analytical Development – Qualification and Validation supports adherence to relevant regulatory requirements (Good Documentation Practices) and company Standard Operating Procedures (SOPs) as appropriate.
Primary duties/responsibilities:
* Minimum level of education and years of relevant work experience.
* Special knowledge or skills needed and/or licenses or certificates required.
*Special knowledge or skills and/or licenses or certificates preferred.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Click here to return to the careers page