Associate Scientist en SK pharmteco
SK pharmteco · King of Prussia, Estados Unidos De América · Onsite
- Junior
- Oficina en King of Prussia
Position Summary:
SK pharmteco, Cell and Gene US, is looking for a highly skilled Biophysical Testing Associate Scientist/Senior Associate Scientist to join the QC team. The Associate Scientist will primarily engage in analytical development, assay qualification/validation, and GMP testing for gene therapy products. This position is located at our King of Prussia, PA location.
Primary Responsibilities:
- Collaborate effectively with a dynamic team of scientists and multidisciplinary groups involved in the production and analytical testing of gene therapy products.
- Independently conduct experiments and sample testing using a range of biophyscial techniques, including HPLC, CE, DLS, and UV/VIS spectrophotometers.
- Perform laboratory tasks for assay development, qualification/validation, and sample testing of 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 analytical testing in GMP environments according to the company’s requirements.
- Prepare presentations and communicate technical results to internal teams.
- Assist with instrument maintenance and ensure laboratory organization.
- Strict adherence to laboratory safety protocols and compliance guidelines.
- Additional duties as assigned.
Education, Experience, & Qualification:
- Bachelor’s degree in chemistry, biochemistry, chemical engineering, or related discipline.
- At least 1 year of laboratory experience in analyzing samples using HPLC, CE, and/or other analytical techniques is required.
- Working experience in Empower Chromatography Data Software (CDS) is highly preferred.
- Experience in analysis of biological material and experience in pharmaceutical industry 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.
Key Competencies:
- 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
Physical Requirements:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times
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.
