Senior Manager, Quality Control, Cell Separation
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.
Job Description Summary
The Senior Manager, Cell Separation will act as the strategic and functional head of the Quality Control Cell Separation Team. This role will lead the team of technical staff responsible for in-process and finished goods testing of cell separation products and will be responsible for supporting high compliance product quality through method validation activities. The Senior Manager, Cell Separation will establish strong relationships with other departments to ensure quality control requirements are met during product design, process development and scale-up and for the lifecycle of the product.
Duties and Responsibilities
Lead all aspects of the cell separation team
Develop and execute on strategies that maximize efficiency and robustness of processes that meet defined metrics, compliance requirements and customer needs
Develop, oversee, and report key performance indicators to measure and track progress of the cell separation team; identify opportunities for improvement and develop and execute on strategies to address gaps
Contribute to new method development activities and lead method validation activities for cGMP and other high compliance products
Lead and participate in cross-departmental initiatives to drive continuous improvement
Collaborate effectively cross-functionally to ensure timely product disposition and ensure that QC is meeting customer needs
Support the Quality Management System according to ISO 13485 standards and relevant GMP regulations
Work collaboratively with the QC management team to define department objectives and planning strategies
Propose and assist in managing operating and capital budgets
Lead, manage, coach, develop and evaluate direct reports through regular one-on-one and team meetings; conduct and document performance reviews (annual and quarterly goal setting and reviews); make compensation recommendations for direct reports in accordance with Company policies and practices
Assess and evaluate training needs of direct reports; ensure training and development needs are met within department plans and budgets
Support and ensure Quality Control deliverables related to Key Relationship Management (KRM) customers
Advanced degree in Immunology or related Life Sciences and 5+ years of industrial experience in biotechnology industry or equivalent
- Must have a minimum of three (3) years people leadership with experience setting direction for a group, providing strong performance management, leading and driving change and innovation and demonstrated history of achieving goals
- Intermediate to Advanced skills in various technology platforms such as MS Office, Sharepoint, PLM and MRP/ERP software
- Excellent written and verbal communication skills
- Effective planning and organizational skills with the ability to work with a high degree of accuracy
- Ability to effectively multi-task and deal with changing priorities
- Project management experience an asset
- Broad knowledge of biological product development and commercialization including Quality Control programs required to support GMP manufacturing, testing, and distribution of Medical Devices, ancillary products or other regulated products
- Experience working with quality management systems (i.e. ISO 13485, 21 CFR 210, 211 & 820), and interpreting regulatory documents such as CFRs, FDA and ICH Guidance documents
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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