Norm Stoffregen

Executive leader responsible for establishing and scaling Enzene’s U.S. biologics and continuous manufacturing operations.

Oversees all site functions including manufacturing, quality, engineering, supply chain, and operational readiness.

Leads build-out and expansion of the Hopewell site to support monoclonal antibody and advanced modality production.

Aligns U.S. operations with global strategy, technical platforms, and long-term capacity planning.

Builds and develops a high-performing leadership team while driving a culture of safety, compliance, and operational excellence.

Oversees technology transfer, regulatory preparedness, and readiness for clinical and commercial supply.

Represents the site in regulatory interactions, customer engagements, and corporate governance forums.

• Led AAV manufacturing including both the drug substance and drug product activities
• Managed all operational aspects of GMP facility: manufacturing, logistics, technical services and manufacturing support
• Supported the transfer of biologic drug substances from Process Development to internal manufacturing team
• Worked directly with the analytical development and QC leads to ensure product quality
• Oversaw all phases of internal manufacturing operations and identifies critical technical issues
• Ensured drug product is manufactured according to applicable regulatory requirements
• Responsible for the manufacturing team interactions with auditors to comply with worldwide regulatory requirements
• Worked directly with the quality organization to reduce deviations, improve batch release, support environmental monitoring efforts and enhance CAPA closure rates
• Responsible for design of internal manufacturing facility to enhance production capacity and minimize deviations

• Managed operational aspects of GMP facility for the production of bulk drug substance
• 5 Direct & 50 Indirect reports – Mfg., Logistics, Technical Services, and Mfg. Support
• Demonstrated significant improvement in Quality Assurance metrics
• Proven ability to enhance business processes to improve efficiency and flexibility
• Demonstrated positive results in transformation of employee culture
• Senior Client Representative for construction of $72M Development Facility
• 6 Direct Reports - OpEx, Outsourcing, Capital Management, and Laboratory Operations supporting approximately 300 scientists and engineers across 3 locations

• Served as the client representative for design and construction of late-stage / commercial launch facility
• Led the design of the facility to ensure compliance to corporate and engineering requirements in addition to providing efficient adjacencies, future expansion, and maintainability of the facility
• Led the selection of single-use process equipment by creating a matrix that evaluated technical capabilities, purchase cost, total cost of ownership, quality, automation requirements, and technical support
• Created staffing plans to support several operational scenarios requiring support from multiple departments
• Represented Biologics Network Strategy in the evaluation of additional (external) manufacturing capacity
• Served as Client Representative for multi-product large-scale manufacturing facility constructed in Ireland

• Completed a 1-year PAI readiness assignment resulting in facility approval with zero 483 observations
• Served as back-room lead during FDA and EMA inspections and as facilitator for subsequent FDA inspection
• Oversaw staff of 7 personnel that provided on-the-floor support during manufacturing operations
• Over the course of two years, managed various QA functions including: QA Field, QA Engineering, Supplier Quality, Training, QA Systems and Operations

• Oversaw staff of 30 full-time personnel
• Completed process validation campaigns for 3 of Bristol-Myers Squibb’s biologic products
• Led team to implement concurrent manufacturing by performing formal risk assessments and updating procedures

• Oversaw staff of 31 full-time and 4 contract personnel
• Increased awareness of cGMP compliance by actively participating in area walkthroughs stressing the importance of inspection readiness and simplifying existing processes
• Implemented on-the-floor document review process to consistently meet or exceed goal of delivery of documents to Quality

• Oversaw a staff of 7 validation technicians (3 full time and 4 contract)
• Led the effort to initiate and complete an entire cleaning validation program (105 studies)
• Authored sections of Biologics License Application for sanitization of process equipment and cleaning validation strategy

• Authored and executed cleaning validation protocols for biopharmaceutical processing equipment including vessels, bioreactors, chromatography equipment, and ultrafiltration units
• Served as the validation project manager during an upgrade of the Media and Equipment Preparation areas

• Oversaw a staff of 10 manufacturing associates in the media / buffer preparation area
• Coordinated internal production schedule to supply cell culture media to 10 perfusion bioreactor systems

• Subject Matter Expert (SME) for media preparation area during startup of new manufacturing facility
• Authored batch records for the preparation of cell culture media and buffer solutions

• Prepared liquid and powdered cell culture media according to company SOPs and batch records
• Performed environmental monitoring in a Class 100 filling area