Company Background:

GenVivo’s mission is to develop innovative gene therapies to treat cancer and prolong patient survival while also improving their quality of life. Our approach to synergistically attack tumors by activating the immune system - combined with the integration of novel companion diagnostics - positions us on the cutting edge of cancer immunotherapies and emerging clinical-stage cancer companies. We are an ambitious, growing company whose employees are enthusiastic and passionate, respectful of each other, and highly committed to our mission and values. The company thrives on collaboration and every individual and each idea is important and counts. 

General Job Description/Team Overview:

As part of a talented and multi-disciplinary team advancing an exciting new approach to gene therapy drug discovery, development, and manufacturing, the successful candidate will support the QC operations and work in a laboratory environment under the direction of the QC Manager. This is an entry-level position and superb opportunity for candidates considering a quality control career in FDA regulated biotechnology and pharmaceutical industry. The level will be determined based upon the candidate’s education, skills, and/or related experience.

Primary Duties and Responsibilities (include but are not limited to):

• Perform routine release testing of raw material, in-process intermediate, drug substance, and final drug product.
• Conduct routine laboratory instrument preventative maintenance, calibration, and cleaning.
• Sample cGMP raw material for release testing.
• Maintain and organize an inventory of laboratory chemicals, reagents, and consumables.
• Perform stability, reference, and reagent qualification, participate in analytical method development and qualification under supervision, and other non-routine testing as needed.
• Review testing raw data, prepare a testing summary report and maintain laboratory notebooks and tracking logs.
• Revise and draft Standard Operating Procedures (SOPs) and Standard Test Methods (STMs) as necessary.
• Assist in tracking and trending of laboratory test results, and investigation of laboratory non-conforming results.
• Dispose of laboratory-generated hazardous waste per approved company procedures.
• Assist in general upkeep of laboratory and maintain a clean work environment.
• Perform other duties as assigned.

Required Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Biological Sciences, or related field.
• Experience in FDA regulated cGMP industry is preferred, but not required.
• Working knowledge of cell culture and aseptic techniques, PCR, cell-based assay, ELISA, gel electrophoresis, spectroscopy, chromatography, and wet chemistry is highly desired.
• Ability to read and follow SOPs and STMs.
• Individual must be a self-motivated and detail-oriented team player, who is energetic and eager to learn.
• Able to stand a prolonged time and lift 30 lbs.
• General knowledge of Federal and State regulatory requirements in a GxP environment.
• Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.
• Excellent organization skills with attention to detail and accurate record keeping.
• General knowledge of Federal and State regulatory requirements in a GxP environment.
• High degree of discretion dealing with confidential information.
• Ability and willingness to work flexible hours when needed.
• Demonstrated ability to work independently and in a team environment.
• Excellent written, verbal and interpersonal communication skills.
• Eligible to work in the U.S.