OVERVIEW:

Tek Wissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients that researches develop, and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.     

DESCRIPTION: 

RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO: 

• Perform all tasks associated with the manufacture of clinical product following batch records and Sops Work as part of a small team to execute GMP runs in close collaboration with Process Development and Quality Assist in the development of standard operating procedures, batch records, deviations and change controls Successfully troubleshoot processing and equipment issues other duties as assigned

REQUIREMENTS: 

• Requires Bachelor's degree and/or advanced degree or 3 or more years of cGMP experience in a manufacturing pharmaceutical/biotechnology environment Cell culture processing experience Previous experience with cell therapy products is a plus  
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture products  
• Strict adherence to SOPs and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing Excellent aseptic/sterile techniques and prior experience with cell culture, cell culture equipment including  
• Wave bioreactors Experience with handling and propagation of human primary cells, including T cells Excellent skill in Microsoft Word, Excel, and data analysis 
•  Ability to think critically, and demonstrated troubleshooting and problem-solving skills Self-motivated and willing to accept temporary responsibilities outside of initial job description Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities 
•  Ability to work off-shift and extra hours as required

TEKWISSEN® GROUP IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER (M/F/D/V) SUPPORTING WORKFORCE DIVERSITY.