Senior Scientist, Process Development (Upstream)

Job Description SummaryDo you enjoy solving complex problems, building relationships with collaborators, and continuously learning in a fast-paced and innovative environment? As a member of the Process Development, Biologics team you will work alongside experienced Engineers, Associates, and Scientists who collaborate closely on delivering robust, cost efficient, and innovative manufacturing processes for biologic products meeting appropriate regulatory and current good manufacturing practices (cGMP) requirements.
As a Senior Scientist, Process Development (Upstream) you’ll lead the planning and technology transfer of upstream processes for protein production. This is an exciting opportunity to leverage existing upstream process development and technology transfer experience and grow as we establish new workflows for GMP projects at STEMCELL!
Duties and Responsibilities:
Provide technical and strategic recommendations to the cross-functional project team and senior management for upstream process development activities towards cGMP protein manufacturing for Ancillary materials
Create the upstream development plans for clinical protein production and be accountable for resulting project deliverables
Provide oversight and guidance on upstream processes and their technology transfer either internally or with CDMOs
Nurture collaborations with cross-functional stakeholders, including R&D, Quality Control, Quality Assurance & Regulatory teams, addressing critical quality attributes and critical process parameters based on product’s intended use and user requirements
Author and review process descriptions, technical reports, technology transfer documentation, SOPs, batch records, regulatory filings and other documentation as needed
Support manufacturing operations by using technical expertise to ensure successful manufacturing campaigns and support NCR investigations and identification of CAPAs
Knowledge and Qualifications:
Doctoral degree with at least 5 years relevant experience or Master's degree with minimum 8 years relevant experience in upstream process development &/or MSAT for antibody/protein products destined for cGMP manufacture
Thorough understanding and hands-on experience of developing upstream processes for use in a cGMP manufacturing environment, ideally for Ancillary materials
Experience in technology transfer to manufacturing facilities, including CDMOs
Experience in leading and managing cross-functional projects is required
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:
$103,800.00 - $155,600.00
STEMCELL 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.
#J-18808-Ljbffr