Jobs at AbCellera

Leads drug product Manufacturing Sciences and Technology strategy for biologics, overseeing external fill-finish manufacturing, technology transfers, process performance, batch documentation, validation, sampling plans, equipment qualification, investigations, CAPA, vendor management, and regulatory filings. Serves as the senior technical authority for CDMOs and drives process improvements, risk management, and cross-functional alignment across development, procurement, quality, and regulatory teams.

Develops pharmaceutical combination products, including prefilled syringes and autoinjectors, through design controls, risk management, verification and validation, human factors, packaging and distribution studies, scale-up, and regulatory submissions. The role oversees external device suppliers and CDMOs, supports quality systems and supplier controls, and collaborates with Quality, Regulatory, Formulation, and Drug Product teams to advance products toward clinical and commercial readiness.

Leads device development strategy for drug-device combination products, including prefilled syringes and autoinjectors, from clinical development through commercialization. Oversees design controls, risk management, human factors, regulatory documentation, quality systems, supplier governance, technical transfers, packaging, and distribution strategies. Manages engineers and external partners while coordinating with Clinical, Quality, Regulatory, Manufacturing, Formulation, Drug Product, Commercial, and Supply Chain teams. Requires extensive combination-product engineering experience and expertise in applicable FDA regulations and international standards.

Leads late-stage and commercial biologics development, establishing CMC and MSAT strategies for antibody therapeutics from clinical manufacturing through commercialization. Oversees process characterization, PPQ, control strategies, regulatory CMC submissions, technology transfers, scale-up, CDMO activities, and manufacturing troubleshooting. Builds technical teams and manages combination-product development, design controls, health-authority interactions, and cross-functional alignment across Quality, Regulatory, Supply Chain, Clinical, and Commercial functions.

Leads the biometrics organization across biostatistics, statistical programming, clinical data management, and analysis from IND-enabling studies through post-approval. Builds teams, shapes clinical data strategy and trial designs, oversees vendors and CROs, ensures GCP/CDISC compliance, supports regulatory submissions and agency interactions, and advises executives and the Board on quantitative methods in drug development.

Conduct bioanalytical and pharmacokinetic research supporting antibody therapeutic and T-cell engager programs. Generate and analyze biological sample data, perform ELISA and MSD ligand-binding assays, develop bioanalytical methods, define PK strategies, and collaborate with pharmacology, safety, modeling, protein science, and biology teams to advance discovery programs toward clinical development.

The job focuses on expanding teams in Protein Science, Drug Development, Manufacturing, Quality, and supporting roles in various scientific and engineering fields.

Leads QA Operations for a biological drug substance clinical manufacturing facility, providing GMP oversight across manufacturing, warehousing, and distribution. Responsibilities include batch record review, material disposition, investigations, CAPAs, change controls, tech transfers, audits, inspection readiness, risk management, continuous improvement, and regulatory compliance. Builds and coaches the QA team while partnering with manufacturing, supply chain, regulatory, QC, MSAT, and logistics stakeholders.

Plans, leads, and oversees international clinical studies from startup through closeout, ensuring compliance with protocols, Good Clinical Practice, regulations, budgets, and timelines. Coordinates cross-functional teams, contract research organizations, clinical sites, and regulatory stakeholders. Manages recruitment planning, study documentation, audits, inspections, risks, data collection and integrity, safety reporting, and corrective actions while protecting participant well-being.

Oversee IT systems supporting drug discovery, modernize infrastructure, mentor team members, and lead technical projects in both cloud and on-prem environments.

The Systems Administrator will manage cloud and on-prem infrastructure, troubleshoot issues, support internal tools, and automate operations to improve efficiency.

Partner with teams as a trusted coach on engagement, development, performance, and hiring. Deliver company-wide HR initiatives, maintain people data in Bamboo, advise managers on compensation and performance, surface team insights to People & Culture, and support recruiting and organizational design.