Our Lonza site in Houston is seeking a Manufacturing Science and Technology Scientist II. As a member of the MSAT Team you are responsible for the successful transfer of Cell Therapy processes into production. You will work interact directly with our clients, manufacturing, and Research & Development scientists. You ensure process scalability and manufacturability. You are in charge of process integration related aspects during campaign preparation and responsible for process supervision and reporting during and after production campaigns. In addition, you will coordinate all process relevant major deviations and process adaptations, and you are responsible for continuous improvement of the manufacturing processes.
Key responsibilities:
Lead and coordinate independently new product introduction (NPI) of Cell and Gene Therapy (CGT) processes into GMP production optimally.
Ensure timely delivery/readiness of technology transfer (TT) campaigns, collaborating with cross-functional programs teams, including Lonza’s partner, and Lonza’s Process Development, Manufacturing, Program Management, Supply Chain, and Quality teams.
Act as an independent Subject Matter Expert (SME) for CGT processes by providing in-depth technical expertise and scientific knowledge.
Responsible and accountable for delivering process-related TT documentation in coordination with internal and external collaborators. Tasks include performing Fit/Gap analysis and Process Failure Modes and Effects Analysis (FMEA), crafting/reviewing Process Flow Diagrams and Batch Records, compiling Bill of Materials, monitoring processes (analyzing manufacturing data, presenting data), and drafting campaign summary protocols and reports.
Lead and support root cause analysis for major process deviations, CAPAs, Changes, Investigations, and all other process-related documentation. Able to assess requested VCN (Vendor Change Notification) independently.
Ensure process is scalable and support process validation activities for late-phase production.
Keep track of significant metrics like Quality records on a consistent basis.
Train, mentor, and guide junior team members throughout NPIs and TT campaigns, including support on troubleshooting process-related challenges.
Assist with all pre-GMP and TT runs, in person or on-call during the execution, as vital, including visits with partners.
Participate as SME in the audits, related to your programs and performed by the clients, as needed.
Perform other duties as assigned by Manager, such as related project Audits support.
Key requirements:
Bachelor’s Degree required in a field of study such as Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or other life science degrees.
Master of Science degree or PhD or equivalent experience in Engineering and/or sciences preferred.
4+ years of relevant experience
Experience with aseptic processing, MSAT or Manufacturing.
Experience with CMC regulations, and international guidelines including but not limited to Federal Drug Administration (FDA).
Experience in biotech industry in technology transfer.
Knowledge of and experience with cell culturing with a preference in Cell Therapy field.
Compensation for the role will depend on a number of factors, including the successful candidate’s qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.