Christopher Watts Email & Phone Number

Raleigh, NC, US

Cambridge, MA, US

Downstream Purification

Cambridge, MA, US

Cambridge, MA, US

• Act as a validation Subject Matter Expert (SME) providing support to multi-function teams, advise operations on validation matters, and serve as point of contact to present validation programs and strategies to.
• Experience with equipment/utility/facility qualifications and general commissioning, qualification and validation
• Experience with investigations, deviations and CAPA management in a regulated pharmaceutical industry.
• Experience and in-depth understanding of validation lifecycle deliverables and documents from equipment design through qualification (starting with URS, to the end of IQ/OQ/PQ).
• Execute and/or lead multiple projects that require qualification work arising from change controls, capital projects, and ongoing supplemental validation deliverable per approved validation plans as a point of contact.
• Work collaboratively with peers within the cross-functional teams (ENG, AUTO, MFG, QE, QC) to manage workload to address priorities, meet schedules, maximize productivity, reduce costs and increase efficiency.

Cambridge, MA, US

• Specifically designs & develops validation protocols, provides expertise to associated equipment & automation design / modifications.
• Coordinates Equipment & Cleaning Validation Protocols (development & management) for specific equipment areas – including presentation of technical training & support to personnel, with on-floor guidance.
• Leads validation innovation project efforts requiring cross-functional & contract resources.
• Completes project management tracking of deliverables for metrics & reporting.
• Attends FAT (Factory Acceptance Testing) for new equipment systems as validation subject matter expert (SME), supports equipment startup & commissioning efforts, as required.
• Provides input & validation expertise to Technology Transfer & project / area support efforts, actively participates in related meetings.

New York, New York, US

• Serve as a delegate to approve cleaning validation protocols, deviation reports, and summary reports in lieu of Validation Management
• Generates and executes documentation for Cleaning Validation ensuring compliance with QA and cGMP systems.
• Leads validation innovation project efforts requiring cross-functional & contract resources
• CFE Trainer that provides training to colleagues for swab qualification and gowning procedures into manufacturing areas.
• Authors assessments and justifications for Validation Management and Investigational use.
• Collaborates with Manufacturing, Investigations, and Statistics & Technology group for investigational support.

New York, New York, US

• Author and execute engineering studies and validation protocols.
• Updated validation related SOPs, as needed.
• Assemble data, documents, write and circulate validation reports for approval
• Follow and comply with GMP, GLP and FDA guidance.
• Create and schedule sample testing with Chemical and Biological labs
• Address deviations through VDRs

Troy, Michigan, US

• Execute cleaning verification and validation studies experiments, and protocols.
• Assemble data and documents
• Understand and follow SOP's.
• Follow and comply with GMP, GLP and FDA guidance.
• Create and schedule sample testing with Chemical and Biological labs

Woonsocket, RI, US

• Use the pharmacy’s computer to access prescription information including patient and prescriber data
• Correctly calculate dosages, prepare prescription labels, and dispense medications for approval by pharmacists.
• Demonstrate accuracy in cashiering, cash handling and credit-card processing, consistently balancing cash drawer.
• Contacted patients for supply and status update under the supervision of the pharmacist.
• Cleaned, maintained and properly sterilized equipment used.
• Assisted pharmacists in managing the pharmacy – Maintained database of the drugs used, and ordered supplies accordingly.

Raleigh, North Carolina, US

• Operated a 30 L bioreactor to learn key microbiological techniques and processes used by biomanufacturing industries as well as SIP and CIP.
• Gained experience in bioreactor operation and design, scale-up, fermentation process, cell growth, optimization, media sterilization and preparation.
• Operated a 2 Liter fermenter to express recombinant protein Pfu CelB in Escherichia coli
• Expressed recombinant antibody fragment scFv13R4 in Escherichia coli using Fed-batch strategies.
• Cloned egfp gene into pET-41a(+) plasmid
• Assessed protein recovery by using affinity chromatography, Bradford Assay, and SDS PAGE.

Raleigh, NC, US

Maintain records of patient health information

Minored Certificate In Biomanufacturing

Bs In Biological Sciences, Human Biology

Bs In Microbiology

General