Pennington, New Jersey

Job Description Summary:

Job Description:

As part of our continued growth, the newly created Associate Scientist I, Quality Control (GMP Testing) - Gene Therapy is responsible for the execution and analysis of compendial assays such as Appearance, pH, Osmolality, Subvisible Particles, and Conductivity to support drug substance/drug product release and stability testing for the gene therapy Technical Operation organization. Testing responsibility may also include well-established bioanalytical assays such as SDS-PAGE, CE-SDS, ELISA and Cell based assays, BCA and HPLC-SEC. S/He is also responsible for communicating assay results to his/her supervisor.

The incumbent works cross-functionally with internal departments and external resources on Quality Control and GMP testing-related issues.

The Associate Scientist I, Quality Control (GMP Testing) - Gene Therapy supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs) including as appropriate.

Primary duties/responsibilities:

  • Performs product testing in support of the in-process, drug substance/drug product release and stability testing for gene therapy manufacturing. These include, but are not limited to, compendial and bioanalytical assays.

  • Documents results in a cGMP compliant manner.

  • Maintains detailed, up to date, and witnessed laboratory notebooks.
  • Performs timely peer review of analytical results.
  • Provides support for checking expiration dates of chemicals in lab.
  • Contributes to departmental activities such as safety inspections and housekeeping.
  • Contributes to ensuring all samples contained within QC refrigerators, freezers and incubators are clearly labeled, segregated and arranged in an orderly fashion.
  • Operates the instruments and interprets analytical data using Empower, Agilent, 32 Karat, SoftMax Pro, etc.

  • Provides support for the arrangement and organization of test folders for samples on test.

  • Contributes to discarding samples after testing is deemed completed.

  • Prepares buffers and laboratory solutions as described by relevant test methods.

  • Contributes to ordering reagents required for testing.

  • Performs other tasks and assignments as needed and specified by management.

* 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 3 years of relevant experience in a pharmaceutical, biotechnology or related environment or a Master's degree in these same disciplines and a minimum of 1 year of relevant experience in these same environments.

* Special knowledge or skills needed and/or licenses or certificates required.

  • Knowledgeable of USP, Ph. Eur. requirements for compendial testing and experience with method execution.
  • Experience with using an analytical balance.

  • Knowledgeable of bioanalytical assays and experience with the method execution.

  • Experience with working in a cGMP laboratory.

  • Proficiency with Microsoft Office (Word and Excel).

  • Excellent verbal and written communication and 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.

  • Small company and/or start-up experience.

  • Experience with Minitab or JMP statistical desirable

**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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Pennington, New Jersey

PTC is a science-driven, patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for patients with rare disease.

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