STEMCELL Technologies Hiring for Quality Control Scientist at Vancouver, BC Full Time

The QC Scientist role is part of the QC CELLCore team which is responsible for developing cell lines in suspension CHO cells, and clone screening to support immunotherapy and immunodiagnostics products within the QC department. The QC Scientist works in close collaboration with QC Managers, Operations, Quality Assurance Managers, and scientists from Process Development (PDV). In this role you will perform work to develop single-cell cloning workflows for seeding, outgrowth, clone characterization with combined titre and productivity, generate antibody producing research cell banks, shake flask adaptation, and manage QC investigations. You will also lead process improvement projects supporting our cGMP clinical cell separation products.

Job Description

Duties and Responsibilities

Stable cell line generation and cell culture using suspension CHO lines.

Liaise with CMOs and oversee development of research cell banks (RBCs) for use in cGMPcell banking campaigns. Establish specifications and user requirements for CMOs.

Responsible for technology transfer of mammalian stable cell line generation operations, including transfection, selection, maintenance and expansion of cell lines, limiting dilution & clone screening, and production of antibodies.

Perform cell banking activities, utilizing aseptic technique, including cell culture thawing, expansions, cryopreservation and characterization using batch records and standard operating procedures (SOP).

Collaborate with multi-functional teams including Process Development, Operations, Analytics to successfully execute projects developing cell lines, qualify and validate cell banks used in immunotherapy and immunodiagnostics applications and CMO outsourcing in the planning, execution, and technical troubleshooting.

Develop single-cell cloning workflows for seeding, outgrowth,clonal characterization, monoclonality with combined titre and productivity.

Review analytical results from cell growth and purification of products (such as SDS-PAGE, Octet) and provide clear data and conclusions of lead clones to the project team.

Onboarding of cell line development equipment/instruments, overseeing equipment qualifications and required reporting.

Development and improvement of QC procedures, writing or revising SOPs and working documents, reports or templates.

Independently lead investigations in collaboration with QA to address change control.

Work with SMEs and CMO’s to conduct any required root cause analysis. Ensure timely and compliant closure of investigations, deviations, and CAPAs. Subject matter expert leading QC high impact deviations, Out-of-Specification (OOS) laboratory investigations, and CAPAs as required.

Demonstrates innovative and independent scientific-technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures and development of new procedures as it relates to cell line development.

Generate summary reports that can be used to support regulatory filings

Recognized as a “go-to” person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations.

Represent the QC department on cross-functional project development teams.

Ability to coordinate and facilitate meetings, lead conversations, and influence teams.

Work under limited supervision, with the ability to problem-solve, manage priorities, and make decisions independently.

Communicate written and verbal updates to managers, project managers, and senior level management.

Qualifications

Bachelor’s degree in science field with 5-8 years of experience OR Master’s degree in science field with 3-5 years of experience OR Ph.D. in science field with 2-4 years of experience, including 2 years of GMP experience or regulated industry.

Experience (preferred): Experience with scalable mammalian (CHO) cell culture processes for production of antibodies.

Knowledge of ICH Q5D (Derivation and characterization of cell substrates used for production of biotechnological/biological products) guidelines or the PTC (Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use).

Excellent written and verbal communication skills.

Effective planning and organizational skills with the ability to work with a high degree of accuracy.

Comfortable analyzing scientific datasets and have experience with change controls and electronic document management systems

Familiarity with early stage process optimization, media and feed development and high throughput micro bioreactors.

Ability to rapidly and accurately identify root causes and adjust accordingly.

Comfortable understanding and troubleshooting complex experimental setup.

This role requires being fully vaccinated against COVID-19 as per STEMCELL’s vaccination policy, the current recommendations by local health authorities and as required by public health orders in place from time to time, including any COVID-19 boosters as recommended by local health authorities and as required by public health orders in place from time to time.

#PhD

STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.

This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities.

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Create an account by selecting the create account button. You will then be asked for your email and to create a password. Your Password must be eight characters long, contain at least one special character, one capital letter, and a number.Once you have created your password you will be asked to upload your resume. Uploading your resume will provide the ability to auto-populate your application with information from your resume. If you prefer to manually complete all of the fields in the application you can do this by clicking next. You can upload your cover letter as an attachment in the attachments screen. Thank you for your interest in STEMCELL!