Ken Ford

Lyndra Pharmaceuticals _{Vice President – Manufacturing: (1/20 – present)}

• Established the Lyndra GMP manufacturing organization including Manufacturing Supervisors, Engineers, Technicians & Operators; Manufacturing Operations Scheduling and Facilities Engineering.
• Built, equipped, qualified and enabled a 10,000 sq/ft GMP Pilot Plant capable of manufacturing up to 2 million GMP clinical doses per year to support Ph 1 through Commercial Launch needs.
• Utilized lessons learned to increase GMP Pilot Plant capability to 3 million doses per year without footprint increase less than 2 years after start-up.
• Incorporated potent compound and controlled substance handling into the manufacturing facility.
• Implemented key process indicators (KPI) continuous improvement program leading to more than 50% cycle time reduction and 30% yield increase.
• Design of the future commercial facility and equipment for continuous processing that will utilize process analytical technology (PAT) and in-process control (IPC) to enable real-time release (RTR)
• Successful $75,000 state grant to train Manufacturing, Quality and Development personnel on Lean, 6-sigma, etc.

Novartis Pharmaceuticals _{Sr. Director – Xiidra® Ophthalmic Product Transfer: (7/19 – 1/20)}

• Transfer of all CMC/Quality knowledge from Takeda to Novartis
• EU MAA Day 120/180 Response to CMC/Quality Questions

Shire Pharmaceuticals (7/13-1/19) acquired by Takeda Pharmaceuticals (1/19-6/19)

_{Sr. Director – Head of Ophthalmic Product Development (4/14 – 6/19)}

• Drug product development group leader responsible for early phase through commercialization formulation/process development, scale-up, clinical supply manufacture at CMO/CRO and QOS/Module 3 submissions (IND, NDA, NDS, MAA, etc.)
• CMC Development Team Lead for ophthalmic products:
  • Xiidra® – Approved in US & Canada, EU MAA submission, 19 international submissions
  • Ophthalmic product digital health & next generation device platform development
  • US, EU and international regulatory agency face to face meeting experience
• Xiidra® divestiture CMC/Quality Lead

_{Senior Principal Engineer – Global Pharmaceutical Engineering: (7/13 – 4/14)}

• Commercial Tech Team Lead for ophthalmic products

Merck & Co., Inc.

_{Assoc. Director – Solid Dosage Late Stage Development & Scale-Up: (9/12 – 7/13)}

• Supervised 4 engineers working on product dev/scale-up and technical projects.
• Leader – Pharm Working Group, international cross-functional team developing a late stage combination product with an aggressive timeline.

_{Assoc. Director – Solid Dosage Pilot Plant: (6/11 – 9/12)}

• Leader – manufacture campaign team for clinical and development manufacturing of solid dosage products.
• Developed an Operations/Development rotation program and onboarding process.

_{Principal Development Engineer– Pharm/Bio Packaging Development: (1/08 – 6/11)}

• Project Leader:  Development of Merck’s first auto injection system required for entry into the BioSimilar/BioBetter market.  High complexity, cross-functional, international external company coordination.
• Supervision of engineers in solid dosage packaging and liquid dose devices.
• Integrated best practices and streamlining for packaging dev dept. activities including new business structures (info share, project tracking system) and new automation/work-flow.
• Recruiting lead for Pharm dev group (~100 people): Designed & implemented onboarding process that hired > 20 people in a single year.
• FMEA, QbD, DFSS, DoE, Product Characterization Study (PCS), Design History File (DHF), Device Master Record (DMR), Registration Stability Studies, etc.

_{Senior Research Chemical Engineer – Liquids & Sterile Process Development: (1/01 – 12/05)}

• Leader – cross-functional Formulation/Filling Development Team for Gardasil^® Ph I through approval and RotaTeq^® Ph I through start of Ph III.
• One year of international experience – Invanz^® manufacturing start-up in France.
• Process manuals, technical reports, clinical consistency campaign, IND updates, BLA sections, Pre-Approval Inspection, atypical process investigations, etc.

_{Project Engineer – Liquids & Sterile Pilot Plant: (7/99 – 1/01)}

• Coordination/execution of development/clinical batches for vaccines and liquid products.

_{Process Engineer – Vaccine & Sterile Process Technical Operations (1/97 – 7/99)}

• Lead – Vaccine closed-system formulation facility start-up team
• Automation system design, IQ/OQ/PQ, SOPs, HAZOPs, functional requirements specs, detailed design specs, manufacture process descriptions, validation procedures, automation test procedures & facility license.

United States Marine Corps _{Reserve (12/88 – 4/94)}

Lehigh University, _{Bethlehem, PA (9/02 – 5/08)}

_{Chemical Engineering, Doctorate of Philosophy}

Thesis research on the granular bed state and flow of granular materials with a focus toward industrial unit operations, primarily in the pharmaceutical industry.  Specific research work includes:

• Demonstrated that the Janssen equation applies to dynamic vibrated granular beds.
• Developed capacitance probe AC signal (novel method) and vane probe systems for studying the bed state at specific points within processing equipment.
• Defined critical vibration force, vibration frequency and granular bed aspect ratios for granular bed state phase change leading to a granular bed state phase diagram.

Massachusetts Institute of Technology, _{Cambridge, MA (9/95 – 12/96)}

_{Chemical Engineering, Master of Science in Chemical Engineering Practice}

Graduate class work and internship projects at Merck & Co., Inc., Dow Chemicals and Dow Corning

University of Rhode Island, _{Kingston, RI (1/92 – 5/95)}

_{Chemical Engineering, Bachelor of Science}

Bristol Community College, _{Fall River, MA (6/90 – 12/91)}

_{Pre-Professional, Associate of Arts}