Lab Manager/Validation Engineer/ Scientist (Molecular Biology)

ANTHONY CEKIC

Berkeley, CA ***** 419-***-****

ad5uc0@r.postjobfree.com linkedin.com/in/anthony-cekic

SUMMARY

Over seven years of lab management experience in addition to skills as a validation engineer. Proven ability to deliver exemplary results using attention to detail, adaptability, and collaboration. Use interpersonal skills, strategic planning, and data analysis skills to overhaul labs and ensure all systems function within regulatory standards. Experienced in lab management, computer systems validation, and ensuring FDA compliance.

EXPERIENCE

AGENUS, Berkeley, CA 11/2021 – 08/2023

Validation Engineer

Reported to the Computerized System Validation Manager to author, review, and execute validation deliverables such as validation plans, URSs, FRAs, SCDS, SOPs, work instructions, requirements traceability matrices, qualifications (IQ, OQ, and PQ), and summary reports using organizational skills to have all laboratory instrumentation validated.

Used project coordination experience to set up, train, and establish the Blue Mountain Regulatory Asset Manager (BMRAM) as the asset management system resulting in more efficient tracking of routine maintenance and periodic review of laboratory instruments.

Generated validation deliverables for several instruments (Softmax Pro microplate reader, Agilent HPLCs, cell counters, irradiators, flow cytometers, prodigy, freezers, and incubators) used in quality assurance, quality control, and manufacturing to allow for conditional release of the systems for operation.

Worked collaboratively to validate the quality management system (Zen QMS) allowing all users to fill out a digital corrective actions preventative actions (CAPA) and impact assessment forms for better data integrity and data management.

AMGEN, Thousand Oaks, CA 11/2020 – 11/2021

Lab Manager

Reported to the Director of R&D Pre-pivotal Attribute Sciences to provide project coordination in transferring laboratory equipment, generating protocols and procedures, and assisting operations management maintain FDA compliance. This included organizing the preventative maintenance, installation, and validation of lab instruments such as UPLCs, HPLCs, GCs, FTIRs, and dissolutions.

Established the mapping and tracking of laboratory instrumentation using MS Project, which led to completion of the objective a month ahead of deadline.

Coordinated with vendors and operations management using Powerpoint, email updates, and MS Teams to manage equipment, repair, and reactivate chromatography instruments that were inoperable for three years.

Established a complex network between internal departments and vendors to decrease instrument downtime by 10%.

Assisted in the implementation of new electronic lab notebook software in the lab resulting in more efficient recordings of data.

LINDE (formerly PRAXAIR), Pittsburg, CA 11/2017 – 10/2020

Quality Control Lab Manager (07/2019 – 10/2020)

Reported to the Plant Manager in lab operations management in an adaptable laboratory setting with a team of eight to fill and analyze medical and industrial gas mixtures.

Used interpersonal communication skills to organize the team to fill six months of back orders resulting in a 40% increase of production and creation of back stock. A first in that plant’s history.

Implemented operational process improvements resulting in an increased lab output by 20%.

Established a new certificate of analysis (CoA) generation program, used data analytics to decrease CoA errors from 10% down to less than 1%; addressing customer quality complaints.

Chemical Lab Technician (11/2017 – 06/2019)

Reported to the Lab Manager and ensured analysis was in compliance with ISO 9001 and FDA cGMP standards and safety regulations. Provided calibrations, maintenance, and repairs on analytical equipment such as gas chromatographs, moisture analyzers, FTIRs, chemiluminescence, and FIDs.

Led method development in protocols and procedures reducing analysis speed by 15%.

Implemented a new records management system increase efficiency in file access and retention.

Developed and implemented several standard operating procedures to expedite training.

UNIVERSITY OF TOLEDO, Toledo, OH 10/2012 – 05/2017

Lab Manager, Researcher (Graduate Student)

Reported to Principal Investigator taking a leadership role with a team of 10 to 30 to lead scientific R&D projects using several techniques related to molecular biology, life sciences, and biochemistry. Coordinated team to execute strategy to oversee daily operations of the lab and became point of contact for any issues that arose.

Built the lab from the ground up including procuring, installing, troubleshooting, technical support, and maintaining lab equipment. Also, coordinated with several departments such as the HSE and facilities to ensure laboratory safety compliance with OSHA, FDA, and CDC safety regulations resulting in our cell culture lab being compliant for BLS Level 2 safety measures.

Established an inventory system (supply chain, purchasing chemicals, maintaining inventory, scheduling, and organizing research meetings) for the workplace, organized lab setup, and repaired and maintained over $1M worth of laboratory equipment.

Engaged in financial management of the lab budget (over $100K a year) by ordering supplies and negotiating with sales reps resulting in a decrease in costs by 20% within first year.

Used immunochemistry (HPLC, Western blotting, Softmax pro microplate reader ELISA, Immunoprecipitation, etc.) to generate three antibodies (one monoclonal and two polyclonal) resulting in their registration as licensed research tools.

EDUCATION

UNIVERSITY OF TOLEDO, Toledo, OH

Master of Science, Molecular and Cell Biology

UNIVERSITY OF TOLEDO, Toledo, OH

Bachelor of Science, Biology

OWENS COMMUNITY COLLEGE, Toledo, OH

Associate of Applied Science, Environmental Health and Safety Management

OWENS COMMUNITY COLLEGE, Toledo, OH

Associate of Science, Pre-biotechnology

PROFESSIONAL DEVELOPMENT

Google Data Analytics Certification, Google (2021)

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