Senior Scientist, Process Development (Downstream)

STEMCELL Technologies Inc; Burnaby; On-site; CAD 104,000 - 156,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits

Career development

Job summary

STEMCELL Technologies Inc. is a Vancouver-based biotechnology company supporting cutting-edge life science research worldwide. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.

As a member of the Process Development, Biologics team you will collaborate with Engineers, Associates, and Scientists to deliver robust, cost-efficient downstream manufacturing processes for biologic products meeting cGMP requirements.

Qualifications

• Doctoral degree with at least 5 years relevant experience or Master's degree with minimum 8 years relevant experience in downstream process development and MSAT.
• Experience in cGMP manufacturing environments, ideally for ancillary materials.
• Experience in technology transfer to manufacturing facilities, including CDMOs.
• Experience in leading and managing cross-functional projects.

Responsibilities

• Provide technical and strategic recommendations to cross-functional project team and senior management for downstream process development toward cGMP protein manufacturing for Ancillary materials.
• Create the downstream development plans for protein production and be accountable for resulting project deliverables.
• Provide oversight and guidance on downstream 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.

Skills

Downstream process development

MSAT

Technology transfer

Cross-functional leadership

Project management

Documentation

Education

Doctoral degree

Master's degree

Job description

Job Description Summary

Do 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.

Job Description

Duties and Responsibilities:

• Provide technical and strategic recommendations to the cross-functional project team and senior management for downstream process development activities towards cGMP protein manufacturing for Ancillary materials
• Create the downstream development plans for protein production and be accountable for resulting project deliverables
• Provide oversight and guidance on downstream 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 downstream process development &/or MSAT for antibody/protein products destined for cGMP manufacture
• Thorough understanding and hands-on experience of developing downstream 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

#LI-JS1 #LI-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:

$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.