The Cell Therapy Expert is involved in all stages of production process maturity (from development or acquisition to continuous commercial Good Manufacturing Practice (GMP) production) and follow up of closed projects.
- Create, finalize and/or approve instructions/forms/protocols related to specific production or generic documentation which could be approved by a Supervisor and relevant stakeholder prior to production start
- Plan, coordinate and perform daily production.
- Produce clinical and commercial material that meets the site’s strategic objects and is compliant with cGMPs and safety regulations.
- Continuously train direct reports working in aseptic environment and manage all A/B area monitoring.
- Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
- Collaborating with the Process Development and Manufacturing Sciences and Technology group to transfer new projects into GMP
- Interact with internal and external stakeholders in the course of production duties
- Identify, develop and implement process improvements
- Generate and revise internal and external documents (SOPs, Batch Records)
- Lead initiations and closures of deviations; serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs
- Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment
- Recommend equipment and other supply purchases within the production areas
- Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions
- Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
- Work closely with various departments and aid other teams as necessary
- Adhere to all cGMP manufacturing operations, documentation and safety guidelines
- Postproduction, prepare all GMP documentation for hierarchy approval.
- Respect environmental health and safety (EHS) rules in working area.
- Must be highly qualified/trained to work in A/B environment.
- Other duties as assigned.
- Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience. Master’s Degree preferred.
- A minimum of 3 – 5 years of experience in biopharmaceutical based GMP manufacturing operations/ Cell Therapy/Human Cell Cultivation.
- Solid knowledge of FDA regulations and GMP systems.
- Experience in cell culture and aseptic manipulations.
- Experience in human cells cultivation preferred.
- Demonstrated technical knowledge of bioreactors, disposable Technology, chromatography, TFF, and aseptic processing a must.
- Excellent oral and written communication skills. Strong technical writing ability required.
- Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
- Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand and sit. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; toxic or caustic chemicals; and risk of electrical shock. The noise level in the work environment is usually moderate. A large amount of the work is completed in a cleanroom environment. While working in the area the gowning requirements are safety glasses, shoe covers, hood, gown, mask boots and gloves. Working conditions can include standing for long periods of time.
APPLY TO: firstname.lastname@example.org