Cell Therapy Manufacturing Technician
Khloris Biosciences, Inc. is seeking innovative and highly motivated cell therapy manufacturing technician to join our team. The selected candidate will work closely with lead manufacturing technicians, scientists, participate in project and team meeting, and work in a multidisciplinary environment.
The duties of this position will involve supporting a multidisciplinary manufacturing team in developing Khloris cell therapy platforms. The ideal candidate will have hands-on expertise and comprehensive understanding of cell therapy manufacturing processes.
• Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
• Supports technical transfer and additional research level testing activities.
• Understands and comply with quality standards and requirements as documented.
• Follow Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Support documentation needs, which may include drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Ability to work in a team environment and independently.
• Complete training sessions and ensure training documentation are maintained.
• Work on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Attends the daily lab meetings.
• Other duties as assigned.
• Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
• 0-5 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture, and associated downstream processing.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments.
• Ability to perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations accurately and reproducibly.
• Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
• Ability to work successfully in a fast-paced team-oriented environment.
• Ability to build relationships quickly and credibly.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Must adhere to Khloris Biosciences core values, policies, procedures and business ethics.
• This position is currently for regular work week hours and may be required to work overtime.
• Proficiency in reading, writing and understanding English.
• Proficiency in Microsoft (Excel, Word, Outlook).
• Must be able to work in Lab setting with Biohazards, and various Chemicals.
• Must be able to work in environment with variable noise levels.
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors.
• Ability to stand/sit/walk for long periods of time
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions
• Ability to lift 20 lbs
Khloris Biosciences is a private biotechnology company located in the San Francisco Bay Area. We are dedicated to revolutionizing medical treatment and prevention of cancer and other diseases by harnessing the unlimited immunotherapeutic potential of induced pluripotent stem cells (iPSCs) for drug discovery, vaccine and cell therapies. See more at www.khlorisbiosciences.com