Laboratory Operations Manager with Regulatory Expertise

Professional Summary

Highly experienced in laboratory management with extensive knowledge in orchestrating efficient laboratory schedule adherence to ensure timely completion of tasks and compliance with regulatory guidelines including FDA, ISO, IATA, DOT, CLIA and OSHA. Strong expertise in biotech research and large-scale pharmaceutical studies. Possesses a solid commitment to team environment dynamics with the ability to also contribute independently and follow leadership directives.

Key Skills Assessment

Proficient aseptic technique, media formulation and buffer preparation, in addition to the skillful use of basic laboratory equipment (e.g. centrifuges, pH meters, autoclaves)

Efficient utilization of ERP systems (SAP, Ariba) as well as Microsoft Office and Microsoft Excel applications

Core knowledge of regulatory requirements, process validations, cGMP and safe working practices

Skilled in revising SOPs, in addition to assisting in drafting quality events such as deviations, investigations and CAPAs.

Thorough understanding of Biological Manufacturing Practices, such as tissue culturing techniques, seeding, cryo-preservation and expansion of cell lines

Excellent communication, leadership and motivational skills geared towards overall self and team development

Able to grasp and master new concepts quickly and efficiently

Work Experience

Laboratory Manager 2005 – Present

Seahorse Bioscience/Aligent, Lexington, MA

Supervises and executes laboratory operations to ensure safety of the technicians and quality of the product

Assumes Safety Officer role responsibilities, such as managing amendments and renewals for lab permits and protocols

Manages laboratory equipment by scheduling regular preventative maintenance and troubleshooting equipment errors to minimize or eliminate loss of equipment up-time

Facilitates inventory management including ordering, receiving and stocking activities for laboratory consumables, chemicals and reagents to maintain appropriate stock levels

Assists senior scientists by performing daily tasks such as cell culturing various cell types, sampling, and intermittent testing

Performs QC testing on raw and finished goods while using good documentation practices to record applicable data

Motivates lab users to ensure work is performed in accordance with cGMPs, pertinent regulations and SOPs

Contributes positively and participates in team projects focused on company ISO certification maintenance

Suggests changes to protocols and SOPs as needed in an effort to maximize operational efficiencies

Laboratory Technician II 1996 – 2005

Becton & Dickinson Bioscience, Woburn, MA

Worked diligently alongside senior laboratory personnel to master techniques used regularly in research procedures and recommended/implemented modifications as needed

Performed surgical tumor implantation in mice as well as post-surgical monitoring and care including health evaluations, surveillance and administering injections

Maintained cGMPs and gowning requirements in an ISO-5 clean room environment

Executed cleaning and sanitization protocols

Maintained procedures and protocols to reflect current, approved operations processes

Collected biological samples analysis and animal care records for review and retainment

Prepared laboratory by performing supplies setup and equipment calibrations needed for daily operations

Executed vialing, stoppering, crimping, sterilization and quality inspection procedures using semi-automated and automated equipment

Facilitated inventory management activities

Prepared buffers and other various solutions through to final dispense for routine production.

Used raw data to perform statistical calculations, data trend analysis and develop summary reports for upper management review

Education

Lowell High School, Lowell, MA 1995

High school diploma

Additional Certifications

OSHA 30 Certified

Lion Technology Inc.

RCRA Hazardous Waste Management Certified

Lion Technology Inc.

CPR Certified

American Heart Association

Extracurricular Involvement

Yearly participant in the Kidney Walk sponsored by the National Kidney Foundation.

Yearly participant in the Heart Walk sponsored by the American Heart Association.

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