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Description

The Associate Scientist I, Analytical Development - Gene Therapy (Analytical Chemistry) is responsible for the support of analytical method development and method optimization and for the execution and analysis of well-established, routine assays (e.g. analytical ultracentrifugation (AUC), CE-SDS, DLS, SEC-HPLC, RP-HPLC, IEX-HPLC, SEC-MALS, SDS-PAGE, UV-VIS) supporting the gene therapy analytical development organization. S/He is also responsible for communicating assay results to his/her supervisor and presenting results to internal department meetings as needs.


The incumbent works cross-functionally with internal departments and external resources as necessary on Analytical Development-related matters. 


The Associate Scientist I, Analytical Development (Analytical Chemistry)– Gene Therapy supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs) including as appropriate. 




Essential Functions:

Primary Duties/ Responsibilities:

  • 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 AUC, CE-SDS, DLS, SEC-HPLC, RP-HPLC, IEX-HPLC, SEC-MALS, SDS-PAGE, UV-VIS. Generates reports, and archives assay data.
  • Responsible for communicating assay results and instrument problems to his/her supervisor with a timely manner.
  • Responsible for ordering lab supplies and materials if needs.
  • Responsible for performing instrument troubleshooting under guidance.
  • Author SOP and method development report and present analytical method development progress and test results if needs.
  • Work hard and efficiently to meet the timeline/deadline of projects.
  • Adapt to task and timeline change based on project needs.
  • Able to follow supervisor’s guidance to finish required tasks with a timely manner.
  • Assists the gene therapy process development team in the analysis and interpretation of assay results.
  • Applies relevant scientific principles and techniques to analytical development problems.
  • Maintains detailed, up to date, and witnessed laboratory notebooks.
  • Participate lab activities such as cleaning, organization, and inventory if needs.


Requirements

Knowledge/Skills/Abilities Required

* Minimum level of education and years of relevant work experience.

  • A Bachelor’s degree in chemistry, biochemistry, biophysics 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.

  • Hands on experience with UPLC/HPLC (RP, SEC and IEX) and capillary electrophoresis (CE) to support biologics, vaccine or gene therapy development.
  • Hands on experience with method development and optimization by following ICH guidelines.
  • Hands on experience with instrument troubleshooting.
  • Hands on experience with AUC, DLS, SEC-MALS, SDS-PAGE, UV-VIS is a plus.
  • Work experience under GMP environment is a plus.
  • Biologics and/or gene therapy experience is a must.
  • Ability to work independently and collaboratively under minimum supervision, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Able to draft SOP and method development report under minimum supervision is a must.
  • Able to present analytical method development progress and test results is a must.
  • Willing to work hard and learn new techniques.
  • Proficiency with Microsoft Office.
  • Excellent verbal and written communication skills.
  • 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.





**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.

Job Information

  • Job ID: 63756551
  • Location:
    Pennington, New Jersey, United States
  • Position Title: Associate Scientist I, Analytical Development (Analytical Chemistry) - Gene Therapy
  • Company Name For Job: PTC Therapeutics
  • Industry: Biotechnology
  • Job Function: Laboratory Scientist/Manager
  • Job Type: Full-Time
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 3-5 Years

Please refer to the company's website or job descriptions to learn more about them.

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