What are the responsibilities and job description for the Principal Scientist, Large Molecule CMC Bioassay Development position at Denali Therapeutics Inc?
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
Key Accountabilities/ Core Job Responsibilities:
Design, develop, and optimize cell-based, biochemical, and binding assays for potency and functional characterization of biopharmaceutical products.
Develop strategies to address unique challenges associated with complex biologics, such as Fc-fusions, bispecifics, and oligonucleotide-protein conjugates.
Oversee transfer and validation of potency assays at Quality Control (QC) and/or external testing laboratories in compliance with ICH Q2 guidelines and other regulatory requirements.
Oversee the transfer of validated methods to Quality Control (QC) and/or external testing laboratories.
Provide technical support to QC and manufacturing teams to ensure assay performance in GMP environments
Develop and oversee the potency control strategy for late phase biologics programs to ensure consistent product quality and readiness for commercialization.
Establish potency-related specifications and support critical quality attributes (CQAs) assessments in collaboration with cross-functional teams.
Implement control strategies that ensure the alignment of potency assays with overall product quality and stability requirements.
Provide potency testing support as needed to support product characterization and process development
Author and review technical reports, validation protocols, and regulatory submissions (e.g., INDs, BLAs, MAAs).
Collaborate with cross-functional teams, including Analytical Development, Formulation Development, Process Development, Quality Assurance, and Regulatory Affairs, to ensure potency assays and control strategies meet project requirements and timelines.
Qualifications/Skills:
Ph.D. in Biochemistry, Molecular Biology, Cell Biology, or a related field with 10 years of directly relevant experience, or M.S. with 14 years of directly relevant experience in biopharmaceutical CMC assay development.
Extensive expertise in potency assay development, validation, and control strategy implementation for biologics, such as monoclonal antibodies, bispecifics, ADC’s and/or therapeutic proteins.
Demonstrated track record of authoring BLA/MAA regulatory submissions with regard to potency assays and control strategies based on ICH, FDA, and EMA requirements.
Proven experience in developing and implementing cell-based functional assays, ELISA, HTRF, or other relevant potency assay platforms for QC environments
Hands-on experience with assay validation, method transfer, and troubleshooting in regulated environments.
Familiarity with statistical analysis tools and software for method validation and data interpretation.
Strong organizational, communication, and interpersonal skills.
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Salary : $180,000 - $214,600
