QC Biochemist I

Unither Pharmaceuticals • Silver Spring, MD

13d • $64,000 - $80,000 • Onsite

About The Position

You're passionate about science and want to be in a hands-on role supporting our quality testing. The QC Biochemist I will ensure the timely and accurate testing of materials and products while maintaining and ensuring quality and compliance to meet the demands of production and R&D. Analyze samples in support of: instrument qualification; method verification and validation; process validation; in-process testing requirements; R&D, stability testing; and finished product testing Follow company SOPs and cGMP in the performance of all responsibilities Process and analyze bioanalytical and analytical data Prepare solvent mixture, buffers, and reagents as needed for testing Write and review standard operating procedures (SOPs) for equipment operation, methods, and general laboratory procedures as needed Review bioanalytical and analytical data and test results and compare to test specifications Troubleshoot instrument problems and work with the lab supervisor/manager and equipment manufacturer’s technical services to resolve issues Perform instrument maintenance and calibration verification/standardization as required

Requirements

• Minimum Requirements
• Bachelor’s Degree in biochemistry or chemistry or other scientific discipline with equivalent experience/training
• Able to manage timelines and goals efficiently and effectively
• Must be in compliance while working in a GMP environment
• Must be collaborative as QC is a service department and we provide a service for other departments
• Able to work as part of a team and also independently with minimum supervision
• Good verbal and writing communication skills
• Able to handle, pick up and move laboratory materials, reagents and supplies
• Proficient in Word and Excel

Nice To Haves

• Preferred Qualifications
• 1+ years of experience in laboratory environment
• 1+ years of experience in a QC environment
• Experience in cGMP documentation in QC environment
• Experience with training, in current good manufacturing practices (cGMP)
• Experience in FDA and USP testing requirements
• Experience in stability testing programs
• Experience with chromatography software
• Instrumentation experience in HPLC, UPLC
• ELISA experience

Responsibilities

• Analyze samples in support of: instrument qualification; method verification and validation; process validation; in-process testing requirements; R&D, stability testing; and finished product testing
• Follow company SOPs and cGMP in the performance of all responsibilities
• Process and analyze bioanalytical and analytical data
• Prepare solvent mixture, buffers, and reagents as needed for testing
• Write and review standard operating procedures (SOPs) for equipment operation, methods, and general laboratory procedures as needed
• Review bioanalytical and analytical data and test results and compare to test specifications
• Troubleshoot instrument problems and work with the lab supervisor/manager and equipment manufacturer’s technical services to resolve issues
• Perform instrument maintenance and calibration verification/standardization as required

Benefits

• Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.
• For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees