Our continued growth (expanding operations July 2019 to the New Jersey Center of Excellence) and commitment to developing our Gene Therapy capabilities has created the following opportunity for an Associate Scientist-I, Analytical Development
The Associate Scientist I, Analytical Development - Gene Therapy is responsible for the execution and analysis of well-established, routine assays (including, but not limited to, qPCR, cell-based and immunoassays) supporting the gene therapy analytical development organization. S/He is also responsible for communicating assay results to his/her supervisor.
The Associate Scientist I, Analytical Development – Gene Therapy supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs) including as appropriate.
Performs product characterization related assays in support of the characterization, method development/optimization, methods transfer, and analytical support for gene therapy product process development and manufacturing. These include, but may not be limited to qPCR, cell-based assay, and immunoassays
Generates, reports, and archives assay data.
Assists the gene therapy process development team in the analysis and interpretation of assay results.
Support the analytical and process development group's daily operational needs by maintaining assay cell lines, controls, standards, and reagent inventories.
Applies relevant scientific principles and techniques to analytical development problems.
Maintains detailed, up to date, and witnessed laboratory notebooks.
* Minimum level of education and years of relevant work experience.
A Bachelor’s degree in biology, molecular biology, virology, biochemistry or related discipline and a minimum of 5 years of relevant experience in a pharmaceutical, biotechnology or related environment or a Master’s degree in these same disciplines and a minimum of 2 years of relevant experience in these same environments
* Special knowledge or skills needed and/or licenses or certificates required.
Proficiency with the conduct of qPCR, cell-based assays, and immunoassays.
Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization.
Proficiency with Microsoft Office.
Excellent 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 at various stages of development.
*Special knowledge or skills and/or licenses or certificates preferred.
Small company and/or start-up experience.
* Travel requirements
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.