Principal Scientist, Late Phase and Commercial Analytical and Formulation Development

Denali Therapeutics; South San Francisco (CA); On-site; USD 159,000 - 207,000; Full time

Benefits offered by this job

401k

Healthcare coverage

Employee stock purchase plan (ESPP)

Job summary

Denali Therapeutics is seeking a Principal Scientist to provide strategic leadership for late-phase and commercial analytical development and extended characterization. You will oversee control strategy development and implementation at CDMOs, lead method qualification/validation, and guide cross-functional teams to accelerate CMC timelines.

You will mentor scientists, develop state-of-the-art analytical capabilities, and ensure compliant documentation while maintaining strong QA collaboration

Qualifications

• PhD in Analytical Chemistry, Biochemistry, Chemical Engineering, Biophysics, or related field with 10+ years in protein analytics.
• Experience leading multidisciplinary analytical and quality teams.
• Experience with late-phase and commercial analytical lifecycle for large molecules.

Responsibilities

• Lead analytical development and product characterization for late-phase/commercial molecules.
• Oversee CDMO interactions and method transfers/validation.
• Define and execute biologics analytical development strategy for accelerated CMC timelines.
• Mentor junior colleagues and author development documents.

Skills

Analytical leadership

Cross-functional work

DoE statistics

Mass spectrometry

HPLC methods

Biopharma experience

Communication

Problem solving

Education

PhD in Analytical Chemistry or related field

BS/MS with 14+ years experience

Tools

LC-MS/MS

cIEF

Capillary electrophoresis

SPR

Job description

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

As Denali builds internal capabilities to support rapid process and formulation development for our diverse pipeline of large molecules, we are seeking a talented and motivated Principal Scientist to provide strategic technical leadership for late phase and commercial analytical development and extended characterization activities as well as oversight of control strategy development and implementation at contract development and manufacturing organizations (CDMOs).

Key Accountabilities / Core Responsibilities

• Independently lead analytical development and product characterization activities for one or more molecules in the CMC late phase/commercial space, including managing CDMO interactions and driving the development and implementation of overall analytical control strategy.
• Provide oversight of analytical method qualification, validation, and transfer activities at CDMOs, as well as method bridging, comparability, and extended characterization studies.
• Define execute overall biologics analytical development strategy to enable accelerated CMC development and commercial timelines.
• Hands-on, technical execution in the laboratory while providing mentorship to junior colleagues.
• Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods for product quality assessment.
• Perform in-depth physical/chemical characterization of complex biologics.
• Lead critical quality attributes (CQAs) assessments to support phase-appropriate control system strategy.
• Provide technical guidance during testing-related investigations at CMOs/CROs in collaboration with Quality.
• Author and review technical development documents and relevant sections of health authority filings.
• Drive the establishment of internal state-of-the-art analytical capabilities to support accelerated CMC development.
• Ensure rapid and timely, cross-functional analytical support. all relevant CMC-related deliverables.
• Maintain proficiency in the latest analytical technologies and industry guidelines, as well as emerging analytical development strategies.
• Maintain timely and accurate lab records consistent with good documentation practices.
• Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.

Qualifications/Skills:

• PhD in Analytical Chemistry, Biochemistry, Chemical Engineering, Biophysics, or a related scientific discipline, plus a minimum of 10 years of analytical development experience for protein therapeutics in the biotech/biopharma industry; or BS/MS with a minimum of 14 years of relevant experience.
• Previous experience successfully managing multidisciplinary analytical and quality teams to meet program milestones and timelines.
• Previous experience with large molecule late phase and commercial analytical lifecycle activities, including leading/executing successful method transfers, method qualification and validation, bridging studies, comparability and characterization studies, and supporting Quality investigations, including familiarity with applicable GMP requirements.
• In-depth knowledge and extensive hands-on experience in developing a wide array of analytical protein characterization and biophysical methods (e.g. HPLC-based methods, cIEF, capillary electrophoresis, LC/MS, peptide mapping, spectrophotometry, SPR, light scattering, etc.)
• Strong background in developing mass spectrometry-based methods (Intact/reduced MS, peptide mapping, N-/O-glycosylation profiling, disulfide linkage determination, LC-MS/MS analysis) for protein sequence confirmation, identification and characterization of product variants, and comparability evaluations considered highly preferable.
• Prior experience developing bioanalytical assays or advanced/specialized mass spectrometry characterization approaches, such as tandem mass spectrometry, quantitative analysis, and host cell protein analysis, is considered a plus.
• Strong grasp of statistical approaches for design-of-experiments (DoE) analytical method development, robustness testing, and data analysis.
• Strong grasp of relevant current industry guidelines (ICH, Pharmacopeia, FDA/EMA guidance) and best practices (BioPhorum or other consortia white papers).
• Demonstrated ability to work effectively and collaboratively with other scientists on cross-functional projects teams as well as CDMOs.
• Ability to make thoughtful and meaningful recommendations and/or manage relationships in order to drive efficient advancement of the portfolio.
• Ability to balance competing priorities and thrive in a dynamic, fast-paced environment.
• Excellent critical thinking, scientific problem-solving, and organizational skills
• Excellent oral and written communication skills
• Motivated, detail-oriented, scientifically driven individual with a creative approach to problem solving.

Salary Range: $159,000.00 to $207,000.00 .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.

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.