Process Engineer I

Role Summary

Cell Therapy Technical Operations (CTTO) is seeking a highly motivated Process Engineer I to provide technical leadership for gene delivery and editing products. This role will support process and technology transfers, lead commercialization activities, and provide end-to-end technical process support across the product lifecycle. The successful candidate will serve as a technical Subject Matter Expert (SME), partnering with internal and external stakeholders to ensure robust, compliant, and scalable viral vector processes. Travel of approximately 10-20% is expected.

Responsibilities

• Support process and technology transfers, change management, and technical process support for gene delivery and editing products.
• Serve as a technical Subject Matter Expert (SME) within CTTO and across cross-functional project teams.
• Author regulatory filing sections throughout the product lifecycle.
• Assess process capability and lead investigations through analysis of manufacturing process data.
• Own and lead deviation investigations and associated change controls.
• Provide technical oversight during technology transfer and GMP manufacturing campaigns with Contract Development and Manufacturing Organizations (CDMOs).
• Review and approve GMP manufacturing documentation as required.
• Analyze and present manufacturing data to internal and external stakeholders to drive decision-making.
• Lead cross-functional teams in defining and implementing process control strategies.
• Support the commercialization and lifecycle management of viral vector products.
• Represent CTTO as the technical lead on internal strategy and governance teams.
• Willingness to travel 10-20%.

Qualifications

• B.S. or M.S. in Chemical Engineering, Bioengineering, Biotechnology, or related field with 4-8 years of relevant experience in process development or commercial manufacturing, or Ph.D. with a minimum of 2 years of relevant experience.
• Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and manage multiple projects.
• Experience with leading deviation investigations and owning change controls
• Experience providing technical support in clinical or commercial GMP environments.
• Strong knowledge of cGMP, ICH guidelines, PPQ (process validation), and control strategy development.
• Experience authoring, reviewing, and approving GMP documentation.
• Familiarity with disposable technologies such as single-use bioreactors (SUBs) and mixers (SUMs).
• Experience with data analysis tools (e.g., R, SAS) and root-cause analysis methodologies.
• Experience with process control strategies and Six Sigma principles a plus.
• Strong communication and presentation skills, with the ability to clearly explain complex technical concepts to cross-functional stakeholders.
• Knowledge of cellular immunology and/or vector manufacturing preferred.
• Knowledge of lentiviral or adeno-associated virus (AAV) manufacturing is a plus.