Senior QC Chemistry Analyst

Resilience•Mississauga, ON

7d•Onsite

About The Position

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. The incumbent will be responsible for testing in-process materials, validation, stability, and final products for bio-chemical and chemical assessment according to cGMP and company specifications. Responsibilities also include bio-analytical and analytical instrument qualification reviewing, training troubleshooting, instrument maintenance, high quality technical writing, leading and authoring Laboratory investigations, writing protocols / reports as well as cross-training of QC Technologists.

Requirements

Strong understanding of GMP, GLP, 21 CFR, ICH, Pharmacopeial and Regulatory guidelines.
Advanced knowledge and practical experience in protein analysis HPLC/UPLC and PCR.
Data analysis, statistics and report preparation with knowledge of MS Word, Excel and Outlook.
Strong attention to detail, self-motivated, highly organized, and able to work in the fast-paced laboratory environment.
Able to multi-task and very flexible based on the job priorities.
Ability to learn new bioanalytical and analytical techniques quickly.
Good verbal and written communication (technical writing/protocols/reports).
Strong presentation skills.
Strong instrument trouble shooting skills.
High quality technical writing.

Nice To Haves

Bachelor’s degree (Biochemistry/ Biotechnology/ Chemistry) with a minimum of 2 years related experience within a quality lab environment (biologics pharmaceutical preferred).
Master’s degree (Biochemistry/ Biotechnology/ Chemistry) with 35 years related experience within a quality lab environment (biologics pharmaceutical preferred)
Advanced knowledge and practical experience in protein analysis such as BCA, Western blot, SDS-PAGE, ELISA, concentration analysis using UV-Vis Spectrophotometer/Cell culture testing
Very good knowledge in HPLC/UPLC/Plate readers/spectrophotometers
Experience on advanced Bioanalytical instruments /HPLC/GC/Imager/IEF

Responsibilities

Perform sample analysis using bioanalytical test methods such as HPLC, UPLC, PCR, BCA, SDS-PAGE, ELISA, Western blot and UV-Vis, as per SOPs and / or protocols.
SME for the assays performed, thorough theoretical understanding of the related concepts.
Respond to internal and external auditors on questions on assays and instruments.
Assist Lab management in internal, client and regulatory audits.
Lead and Execute instrument qualification work as required.
Develop and execute QC studies and write reports.
Once qualified as a trainer, perform cross training of other personnel.
Report to supervisor any deviations from company procedures, or other discrepancies that may affect product quality or cGMP status according to established procedures.
Lead and author lab investigations and deviations by following sound scientific rationale.
Perform routine maintenance on laboratory instruments.
Follow established procedures for reference STDs receipt, inventory, use and discard.
Troubleshoot methods and equipment as required.
Author procedural changes using the change control program in Quality Management System.
Review raw data and audit trails.
Participate in scheduled cleaning and other laboratory housekeeping duties.
Employ good documentation practices when generating raw data, reports, SOPs, and other documentation.
Perform other routine testing after training to support analytical testing requirements in the lab.
Ensure documentations and training are accurate and up to date.
Assist in implementation of corrective action plans, participate in identifying root causes and communicate with other departments regarding pending issues.
Able to apply understanding of regulatory guidelines and experience to documents and reports
Performs all other related duties as assigned.
Understanding of data integrity concepts and relevance to good documentation practices.
Able to work flexible shifts and weekends as required.
This role is a permanent afternoon shift