Associate Scientist/Bioanalytical Scientist, Analytical Development

Company Overview:

SKPT pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide – Korea, France, Ireland, and the United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials and analytical services for the pharmaceutical industry worldwide.

Position Summary:

SK pharmteco, Cell and Gene US, is looking for a highly skilled Associate Scientist/Senior Associate Scientist to join the Bioanalytical and Biophysical Analytical Development team. The Associate Scientist/Senior Associate Scientist will primarily engage in analytical development, assay qualification/validation, and analytical testing for cell and gene therapy products.

Primary Responsibilities:

• 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 conduct experiments and sample testing using a range of analytical techniques, including HPLC, CE, DLS, and UV/VIS spectrophotometers
• 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 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:

• Bachelor’s degree in chemistry, biochemistry, chemical engineering, or related discipline
• At least 1 year laboratory experience in 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 prior experience in pharmaceutical industry is preferred
• Previous experience in safe handling of biological material and/or gene therapy product is preferred
• Knowledge in FDA and ICH regulatory guidelines and prior work experience in GMP regulated environment is a desirable
  
  

Additional Skills/Preferences:

• Excellent communication skills
• Meticulous and reliable attention to detail
• Strong eagerness to learn new analytical techniques and broaden knowledge and experience
• Work collaboratively with project teams to accomplish key research goals and meet deadlines.
  
  

Physical Requirements:

• Ability to stand for periods of time working in the laboratory
• Ability to lift up to 15 lbs at times
  
  

Note: This job description is intended to convey information essential to understanding the scope of the job role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.

SK pharmteco Inc., is an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.

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