Senior Manager, Principal Engineer, MSAT in Summit, NJ

About the position

This Senior Principal Engineer, MSAT Process Engineering is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply for multiple products. Areas of responsibility include (a) providing day-to-day manufacturing support, (b) leading manufacturing investigations pertaining to the process control strategy and associated elements, (c) managing multidisciplinary projects aimed at improving the process and/or drug product life cycle sustainability, (d) managing CPV and process monitoring program, and (e) support development and lifecycle management of MBR, MES, and/or eBR. These areas include creation/revision of documentation (i.e. SOP, change control, validation documentation, technical reports, etc.) and management of internal / external team of resources (e.g. engineers and/or scientists) required to support the production of personalized cell therapy products. Cross-functional collaboration with SMEs from the Development Group, Manufacturing Group, Supply Chain Group, and Quality Group is essential to ensuring technical support is delivered to a rapidly growing CAR-T manufacturing organization.

Responsibilities

• Support all MS&T activities to ensure uninterrupted clinical/commercial supply.
• Ensure Safe and Compliant cGMP operations through technical process support for routine clinical/commercial batches and assist QA with on time closure of all quality system records such as deviations, CAPAs and change controls.
• Lead team of engineering and/or scientists for front-line support of the manufacturing process for cell therapies.
• Support product quality evaluations and investigations ensuring compliance with internal standards and regulatory requirements.
• Support Continued Process Validation (CPV) and lead team in support of Statistical Process Control monitoring program and Statistical Alert Event evaluations/investigations.
• Develop, understand, and manage tools/templates to monitor manufacturing process performance and enable understanding of process capability.
• Collaborate within the plant and across the Network.
• Promote mindset of continuous improvement, problem solving, and prevention.

Requirements

• B.S. in Biochemical, Chemical, Biomedical Engineering or Cell Biology/Immunology discipline with 8-10 years of relevant experience; M.S. with 7-10 years; Ph.D. with 5-7 years.
• Four 4+ years of leadership, technical transfer, strategy lead, and management experience.
• Knowledge of cGMPs and multi-national biopharmaceutical regulations.
• Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
• Excellent organization skills and ability to handle multiple tasks.
• Strong verbal/written communication skills.
• Ability to think strategically and to translate strategy into actions.
• Intermediate knowledge of MS Office Applications.
• Experience with MES, ERP, LIMS, or other manufacturing boundary systems.

Nice-to-haves

• Cell therapy experience.
• Knowledge of the relationship between manufacturing processes, ERP, and MES.
• Experience with HP ALM, Electronic Document Management Systems, and Change Management Systems.
• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab).
• Hands-on experience with CAR T or biopharmaceutical manufacturing and Quality Control.

Benefits

• Competitive benefits, services and programs.
• Opportunities for growth and career advancement.
• Work-life balance and flexibility.