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.
Collaborates with GxP Subject Matter Experts (SMEs) and teams to author, review or edit technical GxP documents (and where/when required, verify data) in a clear, concise format.
Performs document Quality Control checks as required.
Ensures good documentation practices are followed.
Coordinates with various departments including, but not limited to, Analytical Development, Process Development, CMC, Regulatory Affairs and Quality Assurance to ensure GxP document(s) clearly represent and communicate processes and are understandable to the reader.
Performs other related tasks and assignments as needed and specified by management related to document generation and control.
* Minimum level of education and years of relevant work experience.
Bachelor’s degree in a relevant scientific discipline and a minimum of 5 years of experience writing relevant documents or reports in a pharmaceutical, biotechnology, contract research organization or related environment/industry OR equivalent experience and/or education.
* Special knowledge or skills needed and/or licenses or certificates required.
Technical knowledge of laboratory procedures in the Biologics/Gene and/or Cell Therapy fields (molecular biology, immunoassay, cell/bioassay).
Ability to plan, write, review, and edit high-quality, technical GxP documents under tight timelines and to ensure these documents adhere to applicable regulatory FDA, EMA, ICH guidelines and standards.
Experience working in a GXP environment.
Demonstrated ability to understand, interpret and communicate technical/scientific subject matter.
Applied experience with process mapping and collaborative document development.
Excellent attention to detail, including fact checking, logical flow, formatting, and document structure.
Proficiency with Microsoft Office and use of electronic document templates.
Excellent interpersonal, verbal and written communication skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
*Special knowledge or skills and/or licenses or certificates preferred.
Broad knowledge of ICH guidelines, FDA CFRs, EMA directives and other regulatory guidelines.
Technical writing certification.
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.