As a Process Development Scientist, you will support the seamless progression of products from initial design through scale-up and technology transfer, ensuring safety, consistency, and quality across the product lifecycle. You will also act as a key subject matter expert, presenting technical information and providing input on cross-departmental and cross-functional project execution.Job Description
Duties and Responsibilities
Act as a technical lead and Subject Matter Expert (SME) in process development of GMP cell culture media products
Apply Quality by Design (QbD) principles in designing and executing product and process characterization studies, conducting risk assessments, and identifying process controls and specifications
Lead the technology transfer of manufacturing process to the GMP manufacturing team, ensuring process information and controls are accurately captured in GMP manufacturing batch records and associated documentation
Lead and/or participate in non-conformance root cause investigations to identify and resolve issues, and provide recommendations on disposition and corrective/preventative actions (CAPA), as required
Support GMP product maintenance and GMP process improvement initiatives by providing technical inputs and conducting studies, as appropriate
Collaborate across departments with cross-functional teams, presenting technical information, authoring technical reports, and reviewing technical documentation
Knowledge and Qualifications
Master's or Bachelor’s degree in a relevant scientific/engineering field with at least 5 years of relevant industry experience
Advanced technical knowledge in process development, and QbD principles and its practical application
Knowledge of industry best practices in experimental design, current good manufacturing practices (cGMP), and regulatory standards as they relate to the biotech/pharmaceutical industry
Good understanding of change management, with strong critical thinking and attention to detail
Excellent written and verbal communication skills
#LI-KM1 #Onsite
STEMCELL Technologies is a privately owned, Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality, we are a company of Scientists Helping Scientists—standing by our customers to provide the outstanding products, technical support, and training they need to advance their research. 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, accessory products, and services. Through our many regional offices, as well as our distribution centers in Vancouver, Seattle, Grenoble, and Singapore, we deliver our innovative, specialized products to more than 100 countries. With over 1,800 employees globally, most with scientific or engineering degrees, 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 meaningful career development opportunities.
STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.
As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.
The annual salary for this job ranges from:
$81,700.00 - $122,500.00STEMCELL determines an individual’s pay within the range based on multiple factors including experience, education, job-related skills, and equity within the team or organization. For jobs that are eligible for sales incentives, the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company policy. In addition to base salary, STEMCELL offers a comprehensive total rewards package including health benefits, retirement savings, and more.
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STEMCELL Technologies Vancouver, British Columbia, CAN Office
Vancouver, British Columbia, Canada
