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, Analytical Development, Oligonucleotide & Small Molecule CMC role.

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

Tailor your resume to this Principal Scientist, Analytical Development, Oligonucleotide & Small Molecule CMC 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, Analytical Development, Oligonucleotide & Small Molecule CMC posting at Denali Therapeutics — free, in seconds.

Don't guess if your resume is good enough.

See how it scores against the Principal Scientist, Analytical Development, Oligonucleotide & Small Molecule CMC posting at Denali Therapeutics — free, in seconds.

Get my score

About the Role

Denali Therapeutics is seeking a scientific leader to head the Oligonucleotide & Small Molecule CMC Analytical Development team. This role involves hands-on scientific leadership in analytical method development, testing, and characterization, with a focus on advancing therapeutic candidates for neurodegenerative diseases and other serious conditions.

Responsibilities

• Lead and mentor the Oligonucleotide & Small Molecule CMC Analytical Development team, developing talent, setting priorities, reviewing data, and enhancing technical capabilities.
• Maintain a regular, hands-on presence in the laboratory.
• Design, execute, troubleshoot, and oversee analytical method development, qualification, validation, transfer, testing, and characterization for oligonucleotide and small-molecule materials and products.
• Lead analytical activities for assigned programs, including impurity characterization, fate and purge, reference standards, stability testing, specifications, and control strategies.
• Establish, operate, and improve internal analytical laboratory capabilities, including instrumentation, workflows, documentation, data integrity, and safety.
• Identify and implement innovative technologies and improvements to strengthen laboratory and program performance.
• Analyze and interpret complex data, integrating knowledge of oligonucleotide processes to resolve technical issues and provide recommendations.
• Serve as the Analytical Development lead on cross-functional program teams, collaborating with various departments to meet program goals.
• Plan and oversee analytical work at CROs and CDMOs, including method transfer, technical guidance, data review, and troubleshooting.
• Author and review specifications, Certificates of Analysis, validation protocols and reports, and relevant analytical CMC sections of regulatory submissions.

Requirements

• Ph.D. in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related discipline with 7+ years of relevant industry experience; or M.S. with 10+ years or B.S. with 12+ years of relevant industry experience.
• At least 5 years of hands-on analytical development experience supporting oligonucleotide and/or small-molecule drug substances and drug products.
• Demonstrated scientific leadership on development programs.
• Ability to lead and mentor a small team while balancing direct laboratory work, technical decision-making, delegation, and timely delivery of results.
• Deep expertise in chromatographic methods, including HPLC/UPLC, and in mass spectrometry.
• Experience with relevant techniques such as GC, XRPD, DSC, TGA, and other physicochemical methods is desirable.
• Strong understanding of oligonucleotide synthesis and purification processes, impurity characterization, fate-and-purge assessments, and analytical control strategy development.
• Working knowledge of method lifecycle activities, stage-appropriate QC testing, specifications, stability programs, data integrity, and CMC regulatory expectations.
• Experience transferring analytical methods and providing technical oversight of CRO/CDMO activities.

Skills

• Analytical method development
• Analytical method testing
• Analytical method characterization
• HPLC/UPLC
• Mass spectrometry
• GC
• XRPD
• DSC
• TGA
• Physicochemical methods
• Oligonucleotide synthesis
• Oligonucleotide purification
• Impurity characterization
• Fate and purge assessments
• Analytical control strategy development
• Method lifecycle management
• Quality control testing
• Specifications development
• Stability programs
• Data integrity
• CMC regulatory compliance
• Method transfer
• CRO/CDMO oversight
• Team leadership
• Mentoring

Location

• Remote

Work Type

• Full-time

Experience Level

• 7+ years industry experience
• 5+ years analytical development experience
• Scientific leadership

Education Level

• Ph.D.
• M.S.
• B.S.

Salary/Compensations

• $159,000.00 to $207,000.00

Benefits

• 401k
• Healthcare coverage
• ESPP

About the Company

• 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.
• 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.
• Learn more at https://www.denalitherapeutics.com/careers

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.