Justen Poole Email & Phone Number

Cambridge, Ontario, Canada

Lead the Formulation and Process Development and R&D Analytical teams.Formulation and Process Development: Responsible for formulation development, process development, scale-up, and supporting technology transfer to/from external production facilities or into internal production.R&D Analytical: Responsible for analytical method development, validation, verification, and transfer in addition to sample testing for pre-stability, formulation development, and process development activities.

Cambridge, Ontario, Canada

Supervise the R&D Analytical team responsible for analytical method development, validation, verification, and transfer in addition to sample testing for pre-stability, formulation development, and process development activities.Responsible for raw material and product specification generation.Support life cycle management activities for both client and Novocol/Septodont commercial products.

Cambridge, Ontario

Provided leadership to the Product Development team for activities such as technology transfer, analytical method development, validation/verification, transfer and general operation of the lab areas.Responsible for performing Elemental Impurity, Residual Solvent and Nitrosamine risk assessments.Continuation of responsibilities of Technical Writer.

Cambridge, Ontario, Canada

Authored analytical method validation, verification, and transfer protocols/reports as well as formulation and process development protocols/reports. Generated eCTD sections for the purposes of NDA and ANDA filings in the USA. Primarily focused on 3.2.P.2 through 3.2.P.7 as well as 3.2.S.4 and 3.2.S.5. Also responsible for drafting responses to agency information requests.Generated raw material, bulk, finished product, and stability specifications based on compendial guidance (USP & EP primarily), ICH Q3, ICH Q6, and ICH M7.Design and generation of registration stability and pre-stability protocols as per ICH Q1.

Cambridge, Ontario, Canada

Developed, validated, and transferred analytical methods for both raw material and drug product testing. In addition, performed analytical testing and evaluation of raw materials, finished products, and stability samples of development batches including experimental R&D formulation trials.

Waterloo Ontario Canada

The focus of my masters degree research was on the development and application of solid phase micro-extraction (SPME) for direct to mass spectrometry analysis of pharmaceuticals and pesticides in environmental water and food matrices. In addition, my research encompassed the development of robust SPME technologies in order to provide minimally invasive in-vivo sampling methodologies to be analyzed using HPLC-MS.

Egbert Ontario Canada

Analysis of environmental air and water samples by gas chromatography mass-spectrometry, as well as determination of physical-chemical properties of flame retardants, legacy and current use pesticides and bromoanisoles. As a part of my research, I participated in ArcticNet 2014 where I collected air and water samples from the Beaufort Sea while aboard the CCGS Amundsen from Kugluktuk, Nunavut to Barrow, Alaska.

Mississauga Ontario Canada

The focus of my work was on ink formulation were I performed and developed tests to characterize specific ink properties.

Aurora Ontario Canada

Performed synthetic organic chemistry, as well as researched the synthesis and purification of active pharmaceutical ingredients.

Lakefield Ontario Canada

Carried out bench scale chemical testing in order to identify and optimize a range of parameters for the extraction of rare earth elements from ore samples.

Master Of Science (M.Sc.), Analytical Chemistry

Bachelor Of Science (B.Sc.), Honours Chemistry, Co-Op