Senior Analytical Laboratory Manager

Eliza Tate

*** **** **** ****, ****** RI ***** · 401-***-****

***********@*****.***

Analytical Laboratory Manager with professional work experience in a Current Good Manufacturing Practice (cGMP) environment in the Contract Manufacturing Organization (CMO) industry. Strong ability to multitask and strategize independently but also as a team, often required to make critical decisions and logical judgements. Excellent communication and leadership skills with ensuring each Laboratory Team member is aware of the common company goal, as well as identifying personal goals, to build overall positive morale, and ensuring compliance within the Quality Control Laboratory group.

SKILLS/ACCOMPLISHMENTS

• 11+ years of experience performing analytical analyses and data review of HPLC, GC, Specific Gravity, pH, Viscosity, Titrations, UV-VIS, FT-IR, TOC, and more in a cGMP environment.

• Established Analytical Laboratory Investigation SOP for a detailed investigation process for out of specification results within the Quality Control Laboratory, following ICH Guidelines.

• Established Analytical Laboratory training practice and procedure for new and existing laboratory personnel.

• Assisted in the roll out of the Electronic Document System (Ensur by DocXellent) and the Laboratory Information Management System (LIMS).

EXPERIENCE

January 2021 – Current

Senior Laboratory Manager, Denison Pharmaceuticals Same Job Function as Finished Product Laboratory Manager, with additional responsibilities including:

• Direct Manager of all QC Laboratory Analysts and Laboratory Support Group, including Method Validation Leader, Stability Team Members, Metrologist and LIMS Administrator, reporting directly to the VP of Quality Systems

• QC Laboratory representative for Analytical and Chemistry related inquiries for 10+ Major Clients

• Works closely with the Business Development team to price new and existing projects and products lines, ensuring maximum revenue for Laboratory Services

September 2015 – January 2021

Finished Product Laboratory Manager, Denison Pharmaceuticals

• Manages a group of 10-15 analysts.

• Scheduling of testing assignments for Finished Products (In Process Check, In Process Bulk and Finished Product samples), Stability and Raw Materials departments of the QC Laboratory, in accordance with the Supply Chain and Customer Service production and shipping schedules

• Performs daily analytical data review in laboratory notebooks, LIMS and Aglient Openlab CDS for Finished Product releases, Stability time points and Raw Materials, ensuring all test results meet product specifications and on trend with expected results.

• Works closely with Quality Systems and other groups as Lead Investigator of multiple Laboratory Out of Specifications, Out of Trends, Investigations, Variances, Deviations and CAPAs, with completion of root cause analysis and risk assessments.

• Performs daily tasks of authoring, revising, and reviewing various Laboratory documents and SOPs to ensure alignment to the current USP and ICH guidelines.

• Performs daily tasks of reviewing other documents outside of the Quality Control Laboratory for Manufacturing and Production departments.

• Works closely with Project Managers during the onboarding process of new products, to ensure all required documents and processes are in place.

• Lead of various laboratory projects for constant improvements to laboratory practices, workloads, and turnaround times

• Laboratory lead for Client and FDA Audits

September 2013 – September 2015

Finished Product Supervisor, Denison Pharmaceuticals

• Supervised a small group of 2-3 other analysts.

• Scheduled testing assignments for Finished Products (In Process Check, In Process Bulk and Finished Product samples) department of the Quality Control Laboratory, in accordance to the Supply Chain and Customer Service production and shipping schedules

• Performed analytical data review of laboratory notebooks for Finished Product releases, ensuring all test results meet product specifications and on trend with expected results.

• Executed Method Validations, Verifications and Transfers, as Lead and Secondary Analyst, and summarized results in an Analytical Report

• Ran various analytical analyses on Finished Product and Stability samples, ensuring all test results meet product specifications.

• Worked closely with Quality Systems as Lead Investigator of multiple Laboratory Out of Specification Investigations and Deviations, with completion of root cause analysis and risk assessments. September 2012 – September 2013

Quality Control Analyst, Denison Pharmaceuticals

• Sampled and inspected Raw Materials per current USP

• Ran various analytical analyses on Raw Materials, Finished Product (In Process Check, In Process Bulk and Finished Product samples), and Stability samples, ensuring all test results meet product specifications.

• Maintained Laboratory Notebook following GLP and cGMP.

• Completed assigned tasks efficiently and accurately in a fast-paced workflow. EDUCATION

MAY 2013

Associates Degree in Applied Sciences, Community College of Rhode Island Completed the Chemical Technology Degree Program; course load included full Inorganic and Organic Chemistry lectures, as well as, hands on Labs focusing on analytical laboratory techniques, such as HPLC, GC, AA and titrations.

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