Senior Process Engineer, MS&T

Summary:

The Sr. Process Engineer is experienced with multiple biologic drug substance / product manufacturing platforms. The position is responsible for both early and late-stage technology transfers. The individual will have the desire to grow in both personal and professional areas of competence. The Sr. Process Engineer is responsible for leading the assessment and technology transfer of new manufacturing processes that support clinical and commercial manufacturing. This position will work cross-functionally to define the manufacturing processes for current Good Manufacturing Practice (cGMP) production.

Responsibilities and Duties:

• Serves as project lead and/or principal investigator of projects to establish cGMP operations and manufacturing.
• Manages departmental deliverables and metrics to ensure compliance with departmental procedures and practices.
• Leads the introduction of new manufacturing processes and methods to facilitate clinical and commercial manufacturing of biological drug substances and products.
• Leads the information transfer and gap assessment of new processes and method transfers.
• Drafts and provides guidance for the preparation of unit operation technology transfer protocols.
• Provides guidance and leads facility fit assessments of manufacturing processes in production suites.
• Ensures compliance with the quality document management system for process changes.
• Provides guidance in the documentation of events and deviations during cGMP manufacturing production.
• Provides guidance for process equipment on-boarding.
• May support other tasks as determined by management.

Basic Qualifications

• Bachelor of Science in engineering typically in chemical engineering, material science and engineering, industrial engineering, or mechanical engineering. A Ph.D. in chemistry, molecular biology, pharmaceutical sciences or other applicable science may be considered;
• Requires 12 years of experience in pharmaceutical or biologics industry in process development or manufacturing operations;
• Requires 8 years of experience in biologics cGMP manufacturing readiness and technology transfer;
• Requires 2 years of supervisory experience;
• Demonstrated process understanding of at least two manufacturing platforms supporting drug substance production and purification using adherent or suspension cell culture; or successful experience in the implementation of two drug product manufacturing process;
• Successful track record of providing deliverables in the areas of cGMP readiness and technology transfer;
• Demonstrated success in late-stage process development (process characterization risk assessments, process performance qualifications, continued process verification);
• Experience in implementing at least one special project related to operational process improvement;
• Strong leadership, relationship management, and organizational planning;
• Ability and willingness to learn and adapt skillsets for various areas of MS&T;
• Ability to perform well under aggressive timelines with maintenance of high-quality output while under pressure;
• Knowledge of cGMP compliance around bioprocess drug substance manufacturing.

Preferred Qualifications

• Bachelor of Science in chemical engineering;
• Coursework in molecular biology;
• Experience with bioprocess drug substance manufacturing process development and CGMP manufacturing (12-years);
• Experience in monoclonal antibody production and purification process development;
• Technical expertise in upstream / downstream operations including equipment knowledge and processes, including but not limited to disposable technologies, clarification holders and devices, chromatography skids, TFFs, formulation processes, final fill, etc.
• Prior cGMP experience (8-years minimum);
• Experience in late-stage process development;
• Knowledge of regulatory compliance in pharmaceutical development.