This is an on-site position located in Pearland, TX.
The purpose of this role is to be the primary technical support team member for our Cell and Gene Therapy manufacturing process. Coordinates campaign preparation in close collaboration with Program Management.
A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer:
Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.
Leading and coordinating independently new product introduction (NPI) of Cell and Gene Therapy (CGT) processes into GMP production successfully.
Ensure on-time delivery/readiness of technology transfer (TT) campaigns, collaborating with cross-functional programs teams, including Lonza's client, 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 delivery of process related TT documentation in collaboration with internal and external stakeholders.
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 scalability and manufacturability and support process validation activities for late-phase production.
Monitors KPI metrics, including Quality records on regular basis.
Train, coach and guide junior team members throughout NPIs and TT campaigns, including support on trouble shooting process related challenges.
Support all pre-GMP and TT runs, in person or on call during the execution, as needed, including client visits.
Participate as SME in the audits, related to the own programs and performed by the clients, as needed.
Bachelor's degree in sciences, biotechnology, biomedical sciences or life sciences' equivalent. Master's or PhD preferred.
Experience in biotech industry in technology transfer.
Knowledge of and experience with upstream and downstream processes, with a preference in viral vector field.
Must know and follow job safety procedures, attend required health and safety training.
Experience within matrix organization.
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Tagged as: Life Sciences
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