Scientist, Analytical Development
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company based in South San Francisco, California that is dedicated to defeating neurodegenerative diseases through rigorous therapeutic discovery and development. 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.
We are seeking a talented and motivated Scientist with a strong background in CMC analytical development and a passion for creative problem solving to join our Large Molecule Analytical and Formulation Development group. The ideal candidate has extensive hands-on experience in developing and qualifying protein analytical methods for assessing product quality, familiarity with large molecule extended characterization, and a strong grasp of CMC process development deliverables.
You will serve as a CMC analytical lead for one or more early clinical programs with responsibility for analytical method development and transfer to QC laboratories as well as overseeing method qualification for GxP release and stability testing. You will also be responsible for performing and/or overseeing extended characterization of biotherapeutics using a variety of methods including mass spectrometry-based methods.
- Hands-on development and optimization of chromatography-, capillary-, and spectroscopy-based analytical methods to be used for product release, stability, and characterization testing.
- Serve as analytical lead for one or more early clinical CMC team including driving method development, transfer to internal/external QC labs, and qualification activities.
- Generate and critically evaluate analytical data to support method development and product characterization.
- Provide rapid and timely analytical support for cell-line, bioprocess, and formulation development activities.
- Author and review technical documents including analytical test procedures, qualification protocols, development reports, stability protocols, and sections of health authority filings.
- Perform in-depth analytical characterization of complex biologics to build a strong understanding of critical quality attributes (CQA).
- Provide technical guidance during testing-related investigations at CMOs/CROs in collaboration with Quality
- Be actively engaged in cross-functional technical decision making.
- Contribute to the development of analytical control strategy and setting specifications for clinical programs in coordination with internal and external partners
- B.S./M.S. in Analytical Chemistry, Biochemistry, Chemical Engineering, Biophysics or related scientific discipline with a minimum of 5 – 8 years of direct CMC analytical development experience in biotech/biopharma or Ph.D. with 2 – 3 years (Scientist) of directly relevant experience.
- In-depth knowledge and extensive hands-on experience in developing analytical protein methods (i.e. analytical HPLC/UPLC-based methods, cIEF, capillary electrophoresis, LC/MS, peptide mapping, etc.)
- Strong background and industrial experience in developing mass spectrometry-based characterization methods (tandem mass spectrometry, quantitative analysis, hydrogen-deuterium exchange, etc.) for the analysis of biotherapeutics highly preferred.
- Excellent laboratory, critical thinking, scientific problem-solving, and organizational skills.
- Demonstrated track record of successfully transferring and qualifying analytical methods at CMOs for protein therapeutic development programs including familiarity with applicable GMP requirements.
- Strong grasp of statistical approaches for data interpretation and analytical method development.
- Demonstrated ability to work effectively and collaboratively with other scientists on cross-functional projects teams as well as external organizations.
- Excellent oral and written communication skills.
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 Range: $121,000.00 to $158,000.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
*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.