Biopharmaceutical professional with **+ years of combined experience in pharmacutical manufacturing, leadership, management, and customer service. Skilled in investigating product and supply discrepancies, RCA, CAPA management, and GMP compliance. Strong materials management skills including forklift training and operation, hazardous and temperature-sensitive materials management and cleanroom applications.

Languages spoken: English and Spanish

4400 Shandwick Dr

Antelope, CA 95843

916-***-****

adr3t2@r.postjobfree.com

Professional Experience

RDX Nova Pharmaceuticals, Vacaville, CA March 2019 – Present

Manufacturing Specialist

•Aid startup pharmaceutical company in the early stages of product manufacturing including:

•Manufacturing small scale test runs for early stage product

•Testing and troubleshooting product processes

•Product stability and process yield testing

•Testing and performing trial purification runs of blind product

•SOP creation and revision

•Act as primary OSHA certified forklift trainer and operator

Unrelated Work

Mike’s Handyman June 2000 – March 2019

Costco December 2017– March 2019

Genentech, Inc. Vacaville, CA July 2005 – December 2017

Senior Technician Cell Culture Manufacturing

•Shift lead for 2 years coordinating work and operations for a team of 13 technicians

•Coached team to an 11 month period of no human errors

•Supported supervisor in short-term and long-term strategy and planning

•Discrepancy Management Owner in Trackwise system to address and remediate process deviations

•Developed a department contingency plan to address critical media prep equipment failure

•Responsible for cleaning and sterilizing vessels, preparing media and solutions, operating fermenters, centrifuges and other harvest system elements

•Troubleshooting equipment and process related issues

•Member of the inventory team and helped improve inventory accuracy from 40% to over 95%

•Led an improvement initiative for the use of reusable process hoses instead of tubing that was regularly discarded ($9000/year savings)

•Trained technicians on forklift and walk-behind machinery operation per Cal-OSHA requirements

Genentech, Inc. Vacaville, CA December 2000 – July 2005

Pharmaceutical Specialist Lead (with Supervisory responsibilities)

•Planned and coordinated operations for the Weigh and Dispense group

•Communicated appropriate cGMP regulations, policies, and SOPs to Materials Management

•Communicated operational, personnel and procedural issues with Management

•Revised SOPs and CRFs

•Coordinated department and interdepartmental activities

•Served as Certified forklift trainer, training Materials Management and Manufacturing departments in forklift operations and safety

Genentech Inc. Vacaville, CA November 1998 – December 2000

Materials Management Technician

•Implemented training, execution, and product management including ordering and receiving

•Weighed and dispensed raw materials

•Ordered and received equipment and manufacturing materials

•Learned and trained others in cGMP regulations and appropriate training forms

•Handled and managed hazardous and temperature-sensitive material

Skills

OSHA & EHS safety oversight GMP Compliance Forklift training and operation

Temp sensitive material handling Crossflow Lyophilization

Fermentation PM oversight Tank Sanitization

Hazardous material handling Cleanroom applications OSHA & EHS safety oversight

Purification Process troubleshooting Root cause analysis

Education, Training & Certifications

South San Francisco High School Graduated 1987

UC Davis Extension

•Supervisory Skills Program Principles of Supervision Annually

•Supervisory Skills Program Performance Management Annually

•Supervisory Skills Program Principles of Team Development Annually

•Supervisory Skills Program Principles of Organizational Development Annually

Training

•Currently Forklift Certified / Certified Trainer

•Annually IATA Certified for transportation of Hazardous Material

•Successfully completed management training programs

•Completed CPR training annually

•Successfully completed programs to become a certified trainer

References

Available upon request

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