Leading the QA and QC teams for Denali's Clinical and Commercial manufacturing site in Utah, ensuring inspection readiness for commercial product launch.
Compensation
Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies.
Responsibilities
Oversee GMP/GLP Quality operations in Utah including quality control laboratories/testing, batch record reviews and release, environmental monitoring, and external testing laboratories.
Accountable for the overall compliance and inspection readiness of the site in preparation for key health authority inspections
Key strategic partner to the Utah site head in developing and maintaining site culture, long term strategy and inspection readiness
Responsible for building, supervising, developing, promoting, hiring and training for the GxP QC and QA team.
Represent Quality on the Utah Site Leadership Team and Denali Quality Leadership Team.
Requirements
BS in a scientific discipline
MS and professional certification in quality, compliance and/or regulatory preferred
Senior Research Scientist/Engineer leading CMC development and operations for protein therapeutics and nanoparticle vaccines at the Institute for Protein Design.
Compensation
Pay Range Minimum: $150,000.00 annual
Pay Range Maximum: $175,008.00 annual
Responsibilities
Own CMC development strategy and sequencing
Coordinate with Core R&D Lead for Process Development
Support integrated development timelines and budgets
Assess manufacturability of research-stage candidates
Provide design input for preclinical studies
Requirements
Ph.D. in biochemistry, bioengineering, chemical engineering, or related field
Lead CMC and Quality program management for global oncology clinical studies, driving strategy, operations, and regulatory submissions across the biologics development lifecycle.
Compensation
$174,000—$204,000 USD
Responsibilities
Cross‑functional collaboration with clinical, non‑clinical, regulatory, manufacturing, and external partners
Develop and maintain detailed CMC submission plans, timelines, and risk mitigation strategies
Prepare high‑impact presentations, decision memos, and status reports for senior management
Implement and refine program tools, workflows, and processes to enhance efficiency and quality
Ensure alignment of CMC deliverables with project milestones and product target profile
Requirements
Bachelor’s degree in life sciences, chemistry, engineering, or related field
Nice to have: Professional proficiency in Mandarin
Lead integrated CMC program for early-stage biologics development and commercialization
Compensation
The salary range for the primary location of this role is: $173,200.00 - $272,600.00
Responsibilities
Lead integrated CMC program for pipeline biologics
Drive strategic and operational alignment across CMC interfaces
Mentor and guide scientists
Support development milestones and regulatory filings
Requirements
Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, Biology, or a related discipline
The role seeks a highly collaborative scientific and matrix leader to lead the Development and Commercialization Team (DCT) for pipeline biologics, moving from candidate selection through early clinical development and First-in-Human (FIH) milestones.
Compensation
$173,200.00 - $272,600.00
Responsibilities
Serve as the Early-Stage Development and Commercialization Team (DCT) Lead for assigned pipeline biologics, holding accountability for integrated CMC development strategy, milestone readiness, and cross-functional alignment.
Lead and operationalize matrixed CMC project teams; establish transparent team structures, functional working groups, clear decision rights, milestone-driven timelines, and escalation pathways.
Drive strategic and operational alignment across key CMC interfaces, including Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, Pilot Plant/Commercial Manufacturing, and external partner organizations.
Frame key program decisions, clarify cross-functional trade-offs, identify and mitigate risks, and ensure timely escalation to functional leadership.
Provide drug product leadership and support for relevant early-stage activities, including composition selection, scalable process development, primary packaging/device considerations, compatibility characterization, technology transfer, scale-up, and regulatory filing support.
Requirements
Senior Scientist – Upstream Process Development (Temporary Maternity Cover)
A Senior Scientist role responsible for hands-on scientific delivery of upstream cell culture process activities supporting biologics pipeline, focusing on process development, scale-up, and technology transfer within a matrix environment.
Responsibilities
Deliver assigned upstream process development activities across CMC cycles
Perform and contribute to the design and interpretation of mammalian cell culture studies using CHO cells, including cryopreservation, revival, inoculum expansion, fed-batch and perfusion processes
Operate high-throughput and bench-scale bioreactor platforms including ambr systems and stirred-tank bioreactors
Apply Design of Experiments (DoE) and multivariate analysis to identify process drivers
Assess cell growth, viability, metabolism, productivity, and culture stability
Responsible for the hands-on scientific and technical delivery of upstream mammalian cell culture process development activities supporting AstraZeneca’s biologics pipeline.
Responsibilities
Deliver assigned upstream process development activities across CMC development cycles.
Perform and contribute to the design and interpretation of mammalian cell culture studies using CHO-based systems.
Execute cryopreservation, revival, inoculum expansion, fed-batch and perfusion processes.
Operate high-throughput and bench-scale bioreactor platforms including ambr systems and stirred-tank bioreactors.
Apply Design of Experiments, multivariate analysis, and statistical approaches to identify process drivers.
Lead project management for chemistry manufacturing & controls development across the R&D pipeline, coordinating cross-functional teams and driving execution of project plans.
Compensation
$117,000.00 - $184,200.00
Responsibilities
Manage end-to-end development process for moderate complexity projects
Guide teams through creation, approval, and execution of integrated project plans
Build and maintain project schedules and critical project information
Leverage relationships and networks to improve team dynamics
Navigate company processes and governance
Requirements
Bachelor’s degree required; concentration in a scientific or applied discipline preferred
Nice to have: Detail-Oriented
Nice to have: Project management certification (PMP)
Nice to have: Formal coursework/training in project management
Nice to have: Experience and knowledge of clinical drug development
Associate Director, CMC / Quality Project ManagementSummit Therapeutics · Princeton, US
Supply Chain Lead - Chemistry Manufacturing and ControlsZS · Buenos Aires, Argentina
Principal Scientist, Early DCT LeadMerck · Rahway, US
Senior Scientist – Upstream Process Development (Temporary Maternity Cover)AstraZeneca · Cambridge, United Kingdom