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 highly motivated multi-disciplinary team advancing an exciting new approach to drug discovery, development, and manufacturing, the successful candidate will be part of a skilled Manufacturing team working to execute GMP production campaigns in close collaboration with the Process Development Team to supply the company’s clinical pipeline targets. Responsibilities for this position include on-the-floor operations in Cell Culture, Purification, and Aseptic Fill/Finish. Additionally, this role will perform manufacturing support activities including, inventory control, and other assigned activities. 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 Cell Culture (Seed Train Expansion and Maintenance, Wave/Rocker Bioreactor Systems, and Single-Use Bioreactor Systems), Purification (Chromatography, Filtration), Buffer and Media preparation, Formulation, and Aseptic Fill/Finish, while adhering to all cGMP and GDP standards.

· Effectively engage cross-functionally with other departments to troubleshoot and continuously improve all operations supporting cGMP manufacturing instruments, equipment, and processes.

· Generate, review, and/or revise batch production records, logbooks, and technically sound Standard Operating Procedures (SOPs) to support manufacturing operations.

· Maintain and sustain all organizational training profile requirements with strict adherence to safety and compliance.

· Engage with external vendors and internal stakeholders to procure and manage equipment and inventory levels.

· Identify, recommend, and implement process improvement initiatives.

· Ensure high-quality and timely completion of assignments and projects.

· Perform other duties as assigned.

Required Qualifications:

· Bachelor’s Degree or higher (STEM field preferred); relevant experience with a high school degree can substitute for this qualification.

· Experience in cGMP operations working with manufacturing equipment. Years of experience will determine the hiring level.

· High degree of self-motivation and the ability to take initiative and work under pressure and against tight timelines.

· Ability to take direction well; follow documents and policies at all times.

· Ability to lift 30 lbs.

· Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others.

· Excellent organizational 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 in 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: $28.00 - $38.00 per hour

Benefits:

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

Schedule:

• 8 hour shift
• Monday to Friday
• Weekends as needed

Ability to Commute:

• San Marino, CA 91108 (Required)

Work Location: In person