PTC Therapeutics, Inc.
Senior Specialist, GMP Facility Coordinator (Manufacturing)
In this newly created role, the Senior Specialist, GMP Facility Coordinator is a member of the Biologics Manufacturing organization and responsible for coordinating facility operations for the GMP manufacturing suites and ensuring the suites maintain the expected aseptic operational conditions as required by GMP manufacturing regulations. This includes providing leadership for the facility cleaning and gowning programs; coordinating facility maintenance events (planned and unplanned); and coordinating all environmental monitoring and utility sampling activities including the completion of any required investigations and providing support to data trending activities within the GMP plasmid and viral vector manufacturing suites. The incumbent plays a key role in the success of the manufacturing teams, as the absence of aseptic conditions or impacted utility systems could result in rejected batches and/or have significant impact on production schedules.
The incumbent will also serve as the Manufacturing organization's primary contact for Environmental Health and Safety (EH&S). She / He will represent Manufacturing in company-lead safety initiatives and conduct routine inspections, investigations, and implementation of best safety practices.
The Senior Specialist, GMP Facility Coordinator works in collaboration with other members of the Manufacturing team and cross-functionally with Facilities & Engineering, EH&S, Quality Assurance, and Microbiology.
The Senior Specialist, GMP Facility Coordinator supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) and will serve as the primary point of contact for GMP facility-related items to Quality Assurance and Site Facilities & Engineering.
Primary duties/responsibilities:
Program Leader – Maintenance of Aseptic Conditions in Classified Suites
Facility Maintenance and Events:
Facility and Utility Sampling:
Safety:
* 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.
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