Corvus Pharmaceutical
Associate Director Analytical Development & Quality Control
Full-Time
$170k - $200k/yr
Senior, Expert
Bachelor's, Master's, PhD
South San Francisco, CA, USA
In Person
On-site in South San Francisco; domestic and international travel may be required.
About the job
Requirements
- An advanced degree in Chemistry, Pharmaceutics, or a related field.
- A Bachelor of Science or Master of Science degree with 10 or more years of industrial experience in small-molecule pharmaceutical development, or a Doctor of Philosophy degree with 7 or more years of industrial experience in small-molecule pharmaceutical development.
- Expertise in high-performance liquid chromatography method development.
- Additional experience with gas chromatography, nuclear magnetic resonance, mass spectrometry, particle-size analysis, solid-state characterization, dissolution, inductively coupled plasma mass spectrometry or optical emission spectrometry, and Fourier-transform infrared spectroscopy.
- A solid understanding of phase-appropriate approaches to control strategy, method validation, and retest or expiry periods.
- Experience in analytical development and validation for drug substances, starting materials, synthetic intermediates, and solid oral drug products.
- Experience managing analytical activities at contract development and manufacturing organizations or contract research organizations.
- Experience managing stability programs, reference standards, and retest or expiry periods.
- Familiarity with International Council for Harmonisation guidelines, current Good Manufacturing Practices, and pharmacopeial chapters.
- Experience managing out-of-trend, out-of-expectation, and out-of-specification results, deviations, and change controls.
- Ability to critically interpret data and articulate technical concepts in multidisciplinary settings.
- Ability to ensure assigned activities are completed according to project timelines.
- Ability to travel domestically and internationally.
Responsibilities
- Direct internal laboratory operations and mentor scientists as a key member of the Chemistry, Manufacturing, and Controls team.
- Oversee analytical instrumentation, reference standards, and stability programs.
- Partner with external vendors to drive phase-appropriate analytical method development for late-stage programs.
- Provide analytical support for regulatory filings.
- Develop methods and perform analytical characterization of drug substances, drug products, and product stability.
- Manage method development, method validation, quality-control testing, and reference-standard management activities internally and at contract development and manufacturing organizations or contract testing laboratories.
- Manage forced-degradation, long-term stability, and predictive-stability studies.
- Contribute to out-of-specification, out-of-expectation, and out-of-trend investigations.
- Critically review data, protocols, reports, specifications, and other documentation.
- Trend stability data and establish retest periods and shelf life using statistical methods.
- Conduct and collaborate on the principles of chemical development and scale-up.
- Author and contribute to Chemistry, Manufacturing, and Controls sections of Investigational New Drug, Investigational Medicinal Product Dossier, New Drug Application, and Marketing Authorisation Application documents.
- Write and review manuscripts for publication.
- Develop strategies to achieve scientific objectives effectively.
- Monitor and evaluate the completion of tasks and projects.
- Analyze complex issues requiring in-depth knowledge of the company and its objectives.
- Negotiate with vendors and management to influence senior leaders on matters significant to the organization.
- Direct and control activities of a broad functional area through partnership with cross-functional department managers.
Desired Qualifications
- Proficiency with Microsoft Office.
- Ability to build effective working relationships throughout the organization internally and externally to achieve goals.
- Flexibility and willingness to solve problems outside the immediate area of expertise.
- Clear and concise verbal and written communication skills, strong organizational skills, and exceptional attention to detail.
- Ability to work independently in an interdisciplinary, fast-paced, and frequently changing environment.
- Commitment to integrity, accountability, transparency, and drive.
About the company
Corvus Pharmaceutical
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