Manufacturing / R&D

Christopher Griffin

*** * ********* *** **** ***, Fort Worth, TX 76102 817-***-**** *********@*****.***

PROFESSIONAL EXPERIENCE SUMMARY

Over 16 years of pharmaceutical experience in multiple settings: Manufacturing/Production, Pharmacokinetics/Drug Metabolism in Research and Development, and Compounding

Training of entry level Compounders

EDUCATION

Stephen F Austin State University, BS in Pre-Med Biology (Major in Biology/Minor in Chemistry, 1998

SKILLS Computer Systems: Microsoft PowerPoint, Excel, and Word, Outlook, ARMS, SCADA, Watson LIMS

Regulations/Processes: cGMP, cGDP, CIP (clean in place), SIP (steam in place), mixing, filter integrity test, bulk sterilization, and sterile transfers, HPLC sample extraction, blood processing, biological sample processing, preparation of reagents, routine sample analysis, laboratory equipment calibration and performance testing, data verification, SOP/ Technical report writing

EMPLOYMENT

Tarrant County Public Health Department

MICROBIOLOGIST I-Bioterrorism Response & Emerging Agents July 14, 2020 - December, 17 2020

Essential Duties and Responsibilities

Performs laboratory analysis of environmental and clinical specimens as assigned and in accordance with all internal and regulatory procedures. Calculates the results of tests performed.

Conducts quality control and preventative maintenance procedures on analytical tests, equipment, reagents, media, and samples. Evaluates results of these procedures, implements corrective action when indicated, and maintains appropriate documentation for all regulatory requirements.

Performs all other related duties involved in the operation of the TCPH as assigned or required.

Responds as needed in the event of a bioterrorism event or any public health threat.Participates in continuing education. other sections of the lab as needed.Provides training as needed on new procedures or for new personnel. laboratory testing results for accuracy, precision, and panic values/regulatory violations.

Reports laboratory results to submitters and regulatory agencies electronically (i.e. computer or fax), in writing, and/or orally and maintains appropriate documentation for all regulatory requirements.

Completes a monthly statement of individual test workload and submitter information.

Maintains a sufficient inventory of supplies needed for test workload. Includes anticipating supply needs and ordering supplies in a timely manner.

Provides test results and information as needed to all customers (i.e. clients, clinics, regulatory agencies) that includes direct customer contact, telephone inquiries, and fax communications.

Participates in proficiency testing and onsite inspections mandated by all regulatory agencies.

Participates in the evaluation and validation of new test methods.

Prepares SOPs and forms per regulatory requirements and updates these as needed.

Smith & Nephew Biothrapeutics, Fort Worth TX

Manufacturing Associate February 2018 - December 2019

Prepare, author, and execute procedural SOP's, specifications, protocols, data analyses, and technical reports, as needed.

Collaborate with various departments to complete procedural SOP’s in a timely manner in order to meet project deadlines.

Responsible for conducting on the job training for incoming Manufacturing Operators.

Responsible for manufacturing a cell based product according to established Master Batch Records and Operating Procedures.

Responsible for the preparation and in-process testing of all media, reagents, substrates for testing, and sanitizing agents used in the manufacturing areas.

Responsible for proper operation of all clean room equipment. Assist with maintenance and equipment validation as needed.

Responsible for maintaining all required records to established guidelines for production procedures, the GMPs, and safety.

Troubleshoot problems with equipment/processes.

Responsible for adherence to all Operating procedures, protocols, policies, regulatory requirements, the GMPs, and the safety guidelines.

Communicate and work with Quality Assurance on product quality/compliance issues.

Responsible for conducting on the job training for incoming Manufacturing Operators.

Authored SOPs and associated forms for Supply Chain.

Authored SOPs for the flash mixer, rotary lobe pump, overhead stirrer, and compounding vessels.

Collaborated on unit SOPs with other manufacturing associates.

Collaborated with Supply Chain on Material Specifications.

Participated in the Santyl and Regranex Walk Through Presentations.

Participated in the Regranex process gap assessment.

Presented the information on the compounding of Santyl and Regranex during the Facility Open House.

EMPQ Team Member

Authored Manufacturing Batch Records for all processes associated with the compounding

of Regranex Gel.

NEOS Therapeutics, Grand Prairie, TX

Compounding and Coating October 2017 to February 2018

Operation of Freund-Vector Coater

Dispense of chemicals required to compound coating solution

Trouble shoot and adjust various settings on coater to ensure said settings stay within parameters specified within the Batch Record

Assembly, disassembly, and cleaning of spray gun for coater

Operation of Neutchze Loader

Accurately weigh chemicals for production, domestic, international and R&D uses

Troubleshoot problems with equipment/processes, alerting maintenance or supervisors as needed

Complete required documentation in accordance with cGMP and cGDP

Review and Revision of Departmental DOPs and Manufacturing Batch Records

Alcon Laboratories, Ft. Worth, TX Senior Bioanalytical Scientist July 2005 to October 2016

Provide bioanalytical support for Alcon projects, including Toxicology, Clinical Pharmacology,

Pharmaceutics, and Marketing Support

Sample analysis

Reagent preparation

Laboratory equipment calibration and performance testing

Data verification

Performance of routine GLP compliance activities

Coordination and execution of Toxicology blood draws

Acquisition and distribution of bioanalytical reference standards

Proactive solicitation of new tasks from the bioanalytical Unit Head

Writing and revision of Unit SOPs

Alcon Laboratories, Ft. Worth, TX Compounder and Trainer October 2000 to July 2005

Set up equipment and perform CIP (clean in place), SIP (steam in place), mixing, filter integrity test, bulk sterilization, and sterile transfers according to SOPs, MBRs, and associated documents for assigned work area

Accurately weigh chemicals for production, domestic, international and R&D uses. Prepare, clean, and sterilize equipment used for manufacturing of bulk product

Perform aseptic powder additions and slurry transfers to sterile bulk pharmaceutical products

Prepare and sterilize ancillary equipment with a steam autoclave

Complete required documentation in accordance with cGMP and cGDP

Troubleshoot problems with equipment/processes, alerting maintenance or supervisors as needed

Perform pH titrations: Use computerized systems in manufacturing and documenting activities

Collaborate with coworkers to meet business objectives and enhance team capability

Communicate and work with Quality Assurance on product quality issues and compliance activities

Communicate and work with Maintenance to resolve problems with equipment

Exchange accurate and complete information regarding production with supervisor, other shifts, and other departments

Communicate and work with Production to ensure efficient CIP/SIP and flush flow of materials and products to/from warehouse

Maintaining master documentation and reviewing production documentation

Participation in cross-functional team

Proficient in the use of the ARMS program

VOLUNTEER EXPERIENCE

Big Brothers Big Sisters of North Texas

Tutor at Union Gospel Mission of Fort Worth

Participated in Habitat for Humanity projects at Alcon Labs

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