PTC Therapeutics, Inc.
Senior Manager, Analytical Sciences & Technology (NJ or Remote based/EST time zone) (Biotech)
The Senior Manager, Analytical Sciences & Technology (AS&T) – Gene Therapy is responsible for method transfers; method improvement; method remediation and method validation/verification and/or troubleshooting for commercial products within the Quality Control laboratories. S/he manages both internal and external programs in the gene therapy space, including but not limited to, stability testing and commercial Drug Substance (DS)/Drug Product (DP) release.
In cooperation with Analytical Development, the Senior Manager, AS&T – Gene Therapy is responsible for investigating commercial product complaints/issues at all manufacturing sites, internal and external.
S/he works cross-functionally in a matrix management environment that includes, but may not be limited to, Analytical Development (AD), Process Development (PD), Clinical and Commercial Manufacturing, Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, Supply Chain, and Discovery Research.
The Senior Manager, AS&T – Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Primary duties/responsibilities:
Note: This position can be based at our Hopewell, NJ location, or be home based (EST time zone)
* 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.
**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.
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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