Associate Director -  Drug Product Analytical Development

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Position Overview: 
 

The Associate Director will lead analytical development and product characterization for an encapsulated cell therapy combination product advancing toward early clinical development. The role is to define how cellular attributes, hydrogel properties, and device architecture drive product function, stability, and therapeutic performance.

This individual will develop and execute analytical strategies supporting IND-enabling studies and early clinical readiness, with responsibility for establishing robust characterization methods and supporting CMC regulatory requirements for cell therapy and combination products.

Works cross-functionally with Biomaterials & Device Engineering, Process Development, Research, and Quality to develop analytical methods for cells within hydrogel matrices and implantable systems. This position is based at Morphocell Technologies headquarters in the Greater Montreal Area.

 

Product Characterization & CMC Support

• Define critical quality attributes (CQAs) linking cell phenotype, potency, and function to hydrogel and device properties.

• Establish structure–function relationships across cell–matrix–device interfaces to support product understanding and control strategy e.g., Quality Target Product Profile.

• Support CMC regulatory deliverables through analytical characterization, analytical method transfer to CDMO, comparability studies, and data packages for regulatory filings.

• Develop SOPs for Tech transfer for key drug product analytical assays

 

Encapsulated Cell Product and Combination product Analytics

• Lead a team of scientists to develop and qualify assays for identity, viability, potency, and functional activity of cells within encapsulated drug product formats.

• Establish non-destructive or minimally disruptive methods to assess cell distribution, retention, and spatial organization within 3D matrices.

• In collaboration with Device Engineering team, establish scale-down models for device as it pertains to release of drug product.

• Support Device engineering group to characterize hydrogel and device properties including degradation, permeability, diffusion, and encapsulation efficiency as they relate to product performance.

• Partner with Engineering teams to integrate and apply analytical methods throughout product development, enabling optimization efforts and generation of preclinical data packages.
   

Stability and Translational Science

• Design studies and analytical tools to support device cryopreservation, post-thaw recovery, in-use stability, and functional durability.

• Collaborate with pre-clinical team to correlate in vitro analytical data with in vivo or preclinical performance, and identification of biomarkers or analytical signatures predictive of potency and long-term function.

 

Future workstream (Advanced Analytical Technologies)

• Implement imaging and quantitative platforms including confocal microscopy, live-cell imaging, and high-content imaging.

• Develop image analysis workflows to quantify viability, morphology, proliferation, and spatial organization in encapsulated systems.

• Apply multiparametric and computational approaches to link structural and functional product attributes.
   

Scientific Execution & Innovation

• Evaluate and implement emerging analytical technologies for 3D cell systems and combination products.

• Develop new assay platforms for hydrogel- and device-enabled cell therapies.

• Communicate findings through internal presentations, regulatory documents, and scientific forums.

• Build collaborative relationships within and outside the organization to advance scientific understanding.

• Mentor junior scientists by instilling scientific curiosity, creativity, and willingness to challenge existing assumptions.
   

Qualifications
 

Educational Background:

• PhD in Bioengineering, Cell Biology, Bioengineering, Biomedical sciences, Analytical Chemistry, or related field. 7+ years industry experience in Cell Therapy, Regenerative Medicine, Biomaterials, or Tissue Engineering. M.S. candidates with significant years of industry experience may be considered.

 

Required Experience / Knowledge / Abilities:

• 7+ years industry experience in Cell Therapy, Regenerative Medicine, Biomaterials, or Tissue Engineering.

• Minimum of 2 years of direct people management experience, with demonstrated ability to recruit, develop, and lead high-performing scientific teams.

• Experience in Analytical Development supporting IND-enabling or early clinical programs.

• Working knowledge of CMC and Regulatory requirements for cell therapy and/or combination products.

• Hands-on experience with 3D cell systems (hydrogels, scaffolds, organoids, encapsulation systems, or implantable devices).

• Experience with imaging-based assays and quantitative biological analysis (flow cytometry, microscopy, or equivalent).
   

Preferred Experience:

• iPSC-derived or primary cell therapies (hepatic, pancreatic, or regenerative indications).

• Encapsulation technologies or implantable combination products.

• Experience with early clinical analytical strategy or regulatory submissions.

• Single-cell, spatial biology, or multi-omics approaches.

• Computational image analysis or quantitative modeling of biological systems

Why Morphocell:

• Join a dynamic team of professionals committed to pushing the boundaries of cell therapy.

• Contribute to groundbreaking advancements in the field of biotechnology.

• Opportunity for personal and professional growth in a fast-paced and collaborative environment.

• Competitive compensation package and benefits.
   

If you are a highly motivated professional with expertise in cell therapy preclinical development and have a passion for driving innovation, we invite you to apply and be part of our mission to revolutionize patient care through cutting-edge therapies.  Please submit your resume and cover letter to: career@morphocell.com
Please note that only selected candidates will be contacted for an interview.