Christopher Knecht Email & Phone Number

New York, US

Lawrence Township, NJ, US

• Leading a Global Supplier Quality team responsible for direct oversight of multiple viral vector contract manufacturing organizations. Established Quality Agreements with all Contract Manufacturing Organizations (CMO)..
• Supported the tech transfer of an adherent viral vector manufacturing process from an internal process development lab to a new control manufacturing organization.
• Partnered closely with BMS’ external manufacturing partners to take a new manufacturing facility through a successful Pre-Licensing Inspection.
• Established Key Performance Indicators (KPI) for all CMO, monitoring on a quarterly basis which has lead to a 20% reduction in batch record review timelines, disposition timelines, documentation errors, and an increase.

Lawrence Township, NJ, US

• Led an 8-person team responsible for direct quality support of a Cellular Therapeutics manufacturing plant including on-the-floor support, batch record review, raw material disposition, change controls, validation.
• Directly supported the launch of four clinical trials in multiple countries and implementation of facility-wide improvements, renovations, procedures, change controls, and CAPAs by providing quality guidance and.
• Implemented multiple department improvements to include standardizing batch record review process and quality walkthroughs of GMP areas to ensure the facility is audit ready.

Cambridge, Cambridgeshire, GB

• Responsible for ensuring launch excellence of existing products into new markets meeting regulatory and labeling requirements while driving on-time delivery. Led new product introductions into the site, scheduled key.
• Led the launch of an existing product into multiple new markets by working directly with the marketing company to understand requirements and/or constraints, develop and communicate a launch plan, and executed with the.
• Led the new product transfer activities of a small molecule and two large molecule products by working closely with CMOs to complete process validation, method transfers, and packaging qualification activities to.

Cambridge, Cambridgeshire, GB

• Responsible for overseeing all QA activities that directly support the manufacturing, filling, and packaging operations. Provide leadership to the quality operations group and coordinates activities across all.
• Developed a tracking system to streamline the batch record review and closure process to decrease turnaround times and increase timely product release.
• Worked closely with the different manufacturing areas to track and trend documentation errors; teamed up to identify effective practices to reduce errors and quicker turnaround times.
• Collaborated with a multifunction group to improve and standardize alarm responses.

Little Rock, Arkansas, US

• Responsible for overseeing all aspects of the Quality Department for a Pharmaceutical Compounding Outsourcer; develop and implement quality systems improvements, procedures, and corrective and preventative actions.
• Developed and executed plans for bringing a compounding pharmacy to cGMP standards; directly worked with the FDA through an initial facility audit.
• Spearheaded the development and implementation of MasterControl Quality System for document management.
• Wrote and executed validation protocols of operational processes (process media fill, cleaning procedures) and equipment (computer systems, refrigerators, Incubators, dry heat oven, autoclave, and new clean room).
• Developed a supply management system for qualifying vendors and the control, inspection, and release of raw materials.
• Trained all employees on cGMP activities.

Brentford, Middlesex, GB

• Lead multiple operations areas in manufacturing and packaging. Responsible for daily operations, weekly supply demands, development and management of operations to support Global Supply Chain to include: responsibility.
• Managing a Manufacturing department consisting of over 30 operators in a Solid Dosage area that consist of dry blending, compression, coating (aquas and enteric) and tablet printing; also a wet granulation area.
• Managing a Packaging department consisting of over 20 operators in an area with two tablet fillers, encapsulation, banding, three bottle fillers and carton packaging lines.
• Supported the development, validation and re-launch of a product with a new supplier of API.
• Drove a continues improvement project to decrease changeover times across all lines by implementing standard scripts, timelines, and processes.

San Diego, CA, US

Lead 16-person team at Amylin Pharmaceuticals responsible for daily reviews of the production schedule; determine shift assignments, overseeing all tasks on the floor, providing assistance and troubleshooting when needed, and daily batch record reviews. Directly responsible for the Bulk manufacturing and drying of sterile once weekly injectable. ·.

Arlington, Virginia, US

Lead 5-person team at Joint Readiness Training Center (JRTC) responsible for observing, controlling, teaching, analyzing, and providing feedback to light, airborne, air assault, and ranger platoons conducting joint training at JRTC. Responsible for employing and maintaining 2 vehicles and equipment worth $1 million, including inventory control and quality.

Arlington, Virginia, US

Led 40-person team at Ft. Carson, CO and in Iraq providing infantry support for 600- person infantry battalion. Responsible for employing and maintaining 8 vehicles and equipment worth over $5 million, including inventory management, tracking parts shipments, and quality assurance. Managed company information systems worth $10,000 and 120-person family.

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Education record