Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

Tailor your resume to this Principal Scientist, Late Phase and Commercial Analytical and Formulation Development role.

Rezi rewrites your resume against Denali Therapeutics's job description. Free.

Tailor your resume to this Principal Scientist, Late Phase and Commercial Analytical and Formulation Development role.

Rezi rewrites your resume against Denali Therapeutics's job description. Free.

Tailor my resume

Don't guess if your resume is good enough.

See how it scores against the Principal Scientist, Late Phase and Commercial Analytical and Formulation Development posting at Denali Therapeutics — free, in seconds.

Don't guess if your resume is good enough.

See how it scores against the Principal Scientist, Late Phase and Commercial Analytical and Formulation Development posting at Denali Therapeutics — free, in seconds.

Get my score

About the Role

Denali Therapeutics is seeking a Principal Scientist to provide strategic technical leadership for late phase and commercial analytical development and extended characterization activities. This role involves oversight of control strategy development and implementation at contract development and manufacturing organizations (CDMOs), aiming to advance therapeutics for neurodegenerative diseases and other serious conditions.

Responsibilities

• Lead analytical development and product characterization for molecules in the CMC late phase/commercial space.
• Manage CDMO interactions and drive the development and implementation of analytical control strategy.
• Oversee analytical method qualification, validation, and transfer activities at CDMOs.
• Manage method bridging, comparability, and extended characterization studies.
• Define and execute overall biologics analytical development strategy to enable accelerated CMC development and commercial timelines.
• Perform hands-on laboratory work and mentor junior colleagues.
• Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods.
• Conduct 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.
• Author and review technical development documents and health authority filings.
• Drive the establishment of internal analytical capabilities.
• Ensure timely, cross-functional analytical support for CMC-related deliverables.
• Maintain proficiency in the latest analytical technologies and industry guidelines.
• Maintain accurate lab records consistent with good documentation practices.
• Lead direct report(s) through goal setting, growth planning, and performance feedback.

Requirements

• 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.
• Previous experience with large molecule late phase and commercial analytical lifecycle activities.
• Experience leading/executing successful method transfers, method qualification and validation, bridging studies, comparability and characterization studies.
• Experience 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.
• Strong background in developing mass spectrometry-based methods for protein sequence confirmation, variant identification, and comparability evaluations.
• Prior experience developing bioanalytical assays or advanced/specialized mass spectrometry characterization approaches is 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.
• Demonstrated ability to work effectively and collaboratively with scientists on cross-functional project teams and CDMOs.
• Ability to make thoughtful recommendations and manage relationships to drive portfolio advancement.
• 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.

Skills

• Analytical development
• Product characterization
• Control strategy development
• Method qualification
• Method validation
• Method transfer
• Bridging studies
• Comparability studies
• Extended characterization
• Chromatography
• Capillary electrophoresis
• Spectroscopy
• Mass spectrometry
• HPLC
• cIEF
• LC/MS
• Peptide mapping
• Spectrophotometry
• SPR
• Light scattering
• Intact/reduced MS
• N-/O-glycosylation profiling
• Disulfide linkage determination
• Tandem mass spectrometry
• Quantitative analysis
• Host cell protein analysis
• Design-of-experiments (DoE)
• Statistical analysis
• ICH guidelines
• Pharmacopeia guidelines
• FDA/EMA guidance
• BioPhorum

Location

• Remote
• Onsite

Work Type

• Full-time

Experience Level

• Principal Scientist
• 10+ years experience
• 14+ years experience

Education Level

• PhD
• BS/MS

Salary/Compensations

• $159,000.00 to $207,000.00

Benefits

• 401k
• Healthcare coverage
• ESPP

About the Company

• Denali Therapeutics is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform.
• The company has the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform, and a growing portfolio of therapeutic candidates.
• Denali aims to deliver effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders, and other serious diseases.

Equal Opportunity

• 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.