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, Formulation & Drug Product Development role.
Rezi rewrites your resume against Denali Therapeutics's job description. Free.
Tailor your resume to this Principal Scientist, Formulation & Drug Product Development role.
Rezi rewrites your resume against Denali Therapeutics's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Principal Scientist, Formulation & Drug Product 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, Formulation & Drug Product Development posting at Denali Therapeutics — free, in seconds.
About the Role
Seeking a Principal Scientist to lead formulation and drug product development for a growing portfolio of protein biologics. This role involves providing technical expertise across the development lifecycle and collaborating with analytical, bioprocess, and quality teams.
Responsibilities
- Drive formulation and drug product development activities for large molecule biotherapeutics.
- Develop understanding of key degradation mechanisms for potential therapeutics.
- Design and execute formulation development studies to identify clinical and commercial formulations, establish shelf life, assess in-use compatibility, and support comparability.
- Develop stress comparability strategies for process changes and scale-up.
- Oversee drug product process development, characterization, and validation for clinical and commercial manufacturing.
- Perform hands-on biophysical and biochemical characterization of protein therapeutics using various analytical methods to evaluate stability, compatibility, and comparability.
- Translate understanding of critical quality attributes and degradation mechanisms into robust formulations and dosage forms.
- Perform risk assessments on the impact of manufacturing and storage conditions on product quality.
- Author technical documents, including formulation development reports, stability protocols, and regulatory filing sections.
- Oversee formulation and drug product manufacturing activities at CMOs, including review of protocols, studies, tech transfer, and specifications.
- Lead troubleshooting activities and serve as SME for Quality investigations at CMOs.
- Participate in cross-functional technical decision-making with Discovery Biotherapeutics, Bioprocess Development, Analytical Development, and Quality.
- Contribute to establishing internal state-of-the-art formulation capabilities for accelerated CMC development.
Requirements
- Typically a PhD in Chemical Engineering, Pharmaceutical Sciences, Biophysics, Analytical Chemistry, or related scientific discipline and 10+ years of relevant industry experience in formulation and drug product development for protein therapeutics.
- Alternatively, a BS/MS with commensurately greater directly relevant experience.
- 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.).
- Prior experience with high concentration liquid formulation development; prefilled syringe (PFS)/combination device process development; and/or process characterization/validation is a strong plus.
- Demonstrated track record of successfully developing biotherapeutic protein formulations and transferring/qualifying DP-related analytical methods at CMOs for protein therapeutic development programs.
- 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 project teams and CMOs.
- Excellent critical thinking, scientific problem-solving, and organizational skills.
- Excellent oral and written communication skills.
- Motivated, detail-oriented, naturally curious individual with a creative approach to scientific problem solving and a positive outlook.
Skills
- Formulation development
- Drug product development
- Protein biologics
- Fc-enzyme fusion proteins
- Protein-oligonucleotide conjugates
- Knob-in-hole multi-specifics
- Analytical development
- Biophysical characterization
- Biochemical characterization
- Chromatography-based analytical methods
- Capillary-based analytical methods
- Spectroscopy-based analytical methods
- Product stability assessment
- Product compatibility assessment
- Product comparability assessment
- Critical quality attributes (CQA)
- Risk assessment
- Technical documentation
- Regulatory filings
- Process development
- Process characterization
- Process validation
- Statistical analysis
- Data interpretation
- Analytical method development
- GMP requirements
Location
- Remote
- Hybrid
- Onsite
Work Type
- Full-time
Experience Level
- Principal Scientist
- 10+ years of relevant industry experience
Education Level
- PhD in Chemical Engineering, Pharmaceutical Sciences, Biophysics, Analytical Chemistry, or related scientific discipline
- BS/MS
Salary/Compensations
- $159,000.00 to $207,000.00
Benefits
- 401k
- Healthcare coverage
- ESPP
About the Company
- Denali's goal is to deliver meaningful therapeutics to patients.
- 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.