Qc Microbiologist

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 help the Quality Control Microbiology team to provide support for the cGMP Manufacturing and Process Development teams, as well as the company’s clinical programs. This position is responsible for conducting microbiological based assays including Bioburden testing, Endotoxin testing, Microbial quantification, and Organism identification. Support the department by identifying or troubleshooting issues that may affect laboratory or facility monitoring or processes primarily in support of QC daily investigations, and other daily QC operations. Participate in release testing of Raw Material, In-Process samples, Drug Substance, and Final Product. 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 microbiology testing of cGMP raw material, in-process intermediate, drug substance, final drug product, and process development sample.

· Perform environmental monitoring for manufacturing cleanroom and personnel monitoring.

· Collect and test facility water samples.

· Conduct method verification and qualification.

· Summarize microbiology and EM testing data, analyze trends and discrepancies, and prepare summary reports per internal SOP.

· Author quarterly and yearly EM and water trending report.

· Perform OOS/OOT investigation related to QC microbiology testing.

· Ensure QC Microbiology processes and procedures are up to date and in compliance with FDA GMP guidelines.

· Maintain instrument preventative maintenance, calibration and qualification, and inventory of the consumables for the QC Microbiology laboratory.

· May perform various QC Analytical testing when deemed necessary by management.

· Perform other duties as assigned.

Required Qualifications:

· Bachelor’s degree in Microbiology or related science field, with a minimum of 1-3 years’ experience in QC microbiology laboratory supporting an aseptic manufacturing process.

· Must have experience with QC microbiology and environmental monitoring testing under FDA regulated cGMP environment.

· Strong technical writing skills and technical acumen in Microbiology.

· Must be self-motivated and results-oriented, and work well in a cross-functional deadline-focused environment.

· Able to stand a prolonged time and lift 30 lbs.

· 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.

Job Type: Full-time

Pay: $25.00 - $38.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person