Senior Manager/Associate Director, QA Operations
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
12+ ans5+ gestionCandidates need 12 years of GxP experience, including at least 5 years in a Quality management or leadership role, plus a Bachelor's or Master's degree. They must know FDA, Health Canada, EU and ICH regulations, have biological Drug Substance and aseptic manufacturing experience, and be proficient in SAP, eQMS and LIMS.
SAP, eQMS, LIMS
Senior Engineer, Combination Products & Device Development
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
8+ ansCandidates need 8+ years of direct drug delivery or combination product experience, ideally with prefilled syringes or autoinjectors. They also need knowledge of FDA design controls, ISO standards, and working with external device partners.
prefilled syringe, autoinjector, needle safety systems
(Senior) Director, Drug Safety and Pharmacovigilance Operations
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
12+ ansCandidates need at least 12 years of drug safety or PV experience, ideally with monoclonal antibodies, and a healthcare degree such as RN, PharmD, PA or NP. They must have expert knowledge of global PV regulations, safety database experience (ARGUS, ARISg, Veeva Vault Safety) and a record of managing FDA, EMA and Health Canada interactions.
ARGUS, ARISg, Veeva Vault Safety
Senior CMC Regulatory Affairs Manager
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
8+ ansCandidates need deep knowledge of CMC regulatory requirements, eCTD structure and Module 3 authoring for biologics and combination products. They also need a thorough understanding of Health Canada, FDA and EMA rules, a bachelor's or advanced degree in a science or engineering field, and about 8 years of relevant experience.
Regulatory affairs, Documentation, CTAS, Regulatory compliance
Scientist II/Senior Scientist
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
2+ ansCandidates need a PhD in biology, biochemistry or a related field with 2-5 years of industry experience (Scientist II) or 5+ years (Senior Scientist), or an MSc with significant industry experience. Hands-on expertise with SEC, RP-LC, CE and icIEF, plus knowledge of FDA, EMA and ICH regulatory requirements for monoclonal antibodies, is required.
LC, CE, icIEF, Empower, Benchling
Research Scientist I - Pharmacokinetics
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
3+ ansCandidates need a strong grasp of antibody pharmacokinetics and hands-on lab experience with plate-based ligand binding assays. A PhD, an MSc with 3 to 5 years of experience, or a BSc with 5+ years of related experience is required, along with clear written and verbal communication.
ELISA, MSD, WinNonlin
Research Scientist II - In Vivo Science
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
2+ ansAbCellera needs a PhD in pharmacology, immunology or a related field with 2 to 5 years of industry experience, or an MSc with 5 to 8 years. Candidates need hands-on in vivo pharmacology work in oncology or biologics and a strong understanding of animal care ethics.
Research, Pharmacology, Pharmacokinetics, Clinical trials, Coaching, Reporting
QC Analyst II
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a Bachelor's degree with 5+ years of QC experience, or a Master's degree in a relevant science with 3+ years. They need strong GMP and data integrity knowledge, hands-on analytical skills, and experience with LIMS and chromatography data systems.
UPLC, CE-SDS, icIEF, ELISA, qPCR, UV-Vis
QA Specialist - Supplier Quality
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a relevant science bachelor's degree and 5+ years of QA experience in a regulated life sciences setting (or a master's with 3+ years). They must know supplier quality management, global cGMP and regulatory requirements, and electronic QMS and ERP systems such as Veeva and SAP.
Veeva, SAP
QA Specialist - Batch Record Review
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a BSc in a relevant science with 5+ years of industry experience, or an MSc with 3+ years, in QA, QC or manufacturing in a cGMP-regulated environment. They need hands-on batch record review experience, knowledge of Health Canada, FDA, EU and ICH cGMP requirements, and strong attention to detail.
ERP system
QA Operations Specialist (15-month contract)
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a BSc in a relevant science with 5+ years of industry experience, or an MSc with 3+ years, ideally in analytical sciences, quality control, or biologic drug manufacturing. They need a strong understanding of cGMP and Health Canada, FDA, EU and ICH requirements, plus a strong attention to detail and data integrity focus.
ERP system
QA for QC Specialist (15-month contract)
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a BSc in a relevant science with 5+ years of industry experience, or an MSc with 3+ years. They must know cGMP, Health Canada, FDA, EU and ICH requirements and have a strong eye for data integrity.
QC instrumentation
External QA Specialist/Manager
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a relevant science bachelor's degree and 5+ years of QA experience (Specialist) or 8+ years (Manager) in a regulated life sciences environment, including external biologics manufacturing. They need deep knowledge of global cGMPs, strong eQMS and SAP or Veeva skills, and excellent attention to detail and communication.
Veeva, SAP
Director, DP MSAT
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
15+ ansCandidates need 15+ years in drug product development and manufacturing of monoclonal or bispecific antibodies, plus a science or engineering bachelor's degree. They need deep knowledge of GMP, aseptic fill-finish for vials and prefilled syringes, and proven CDMO management experience.
Documentation, Procurement, Manufacturing processes, DP, Define technical requirements, Presentation skills
Director, Combination Products & Device Development
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
15+ ansCandidates need a bachelor's or graduate degree in mechanical, biomedical or chemical engineering, at least 15 years of hands-on device engineering, and deep knowledge of FDA and ISO combination product standards. Management of technical teams and external partners is essential.
Leadership, Regulatory compliance, Coaching, Process improvement, Documentation, Risk management