- Collaborate effectively with a dynamic team of scientists and multidisciplinary groups involved in the production and analytical testing of cell and gene therapy products.
- Independently perform PCR-based assays, including ddPCR, qPCR, and RT-qPCR, for applications such as genomic titer, residual DNA, and related QC release testing as assigned
- Perform laboratory tasks for assay development, qualification/validation, and sample testing of cell and gene therapy products.
- Familiarize with various assays conducted by the team and learn to execute them in GLP/GMP environments.
- Ensure accurate laboratory records are maintained.
- Draft technical reports in accordance with good documentation practices and company standard operating procedures.
- Conduct testing in GMP environments according to the company's requirements.
- Prepare presentations and communicate technical results to internal teams.
- Complete reagent qualification and associated documentation.
- Support audits and regulatory inspections as needed.
- Assist with instrument maintenance and ensure laboratory organization.
- Strict adherence to laboratory safety protocols and compliance guidelines.
- Additional duties as assigned.
- Bachelor's degree in science preferably molecular biology, immunology or related discipline.
- At least 1 year laboratory experience in analyzing PCR data or cell based assays is preferred
- Previous experience in safe handling of gene therapy product is preferred.
- Knowledge in FDA and ICH regulatory guidelines and prior work experience in GMP regulated environment is a desirable.
- Excellent verbal and written communication skills.
- Excellent organizational skills and attention to detail.
- Excellent time management skills with a proven ability to meet deadlines.
- Ability to prioritize tasks and to delegate them when appropriate.
- Ability to function well in a high-paced and at times stressful environment.
- Strong eagerness to learn new analytical techniques and broaden knowledge and experience
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.
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Associate Scientist, QC - King of Prussia - SK pharmteco
Description
Title: Associate Scientist, qc
Location: King of Prussia, PA
Department: Technology Development and Analytical Services
Reports To: Manager, QC Testing
*Contract position*
SK pharmteco, Cell and Gene US, is looking for a highly skilled Associate Scientist to join the Bioanalytical and Biophysical Analytical Development team. The Associate Scientist will primarily engage in analytical development, assay qualification/validation, and analytical testing for cell and gene therapy products.
Position Summary:
Education, Experience, & Qualification:
Key Competencies:
Physical Requirements:
As an Equal Opportunity Employer, we believe in each person's potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.
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