Corvus Pharmaceuticals · 1 day ago
Director Analytical Development & Quality Control
South San Francisco, CA
Full-time
Onsite
Director/Executive
$190K/yr - $240K/yr
10+ years expCorvus Pharmaceuticals is focused on advancing innovative therapies, and they are seeking a Director of Analytical Development & Quality Control. The role involves overseeing method development, quality control testing, and ensuring compliance with regulatory standards while managing a team and collaborating with cross-functional departments.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Chemical and physical characterization of drug substance and drug product attributes, identification of technical risks, and collaboration on risk mitigation strategy
Method development for and analytical characterization of drug substances, drug products, and product stability
Management of method development, method validation, QC testing, and reference standard management activities internally and at CDMOs/CTLs
Management of forced degradation, long term stability, and predictive stability studies
Contribution to OOS/OOE/OOT investigations
Critical review of data, protocols, reports, specifications, and other documentation
Trending stability data and establishing retest periods/shelf life using statistical methods
Conducts and collaborates with others on the principles of chemical development, and scale-up
Author and contribute to writing CMC sections of regulatory documents (IND/IMPD/NDA/MAA)
Writes and reviews manuscripts for publication
Develops strategies to ensure effective achievement of scientific objectives
Monitors and evaluates completion of tasks and projects
May develop budgets for capital expenditures and labor
Collaborates with other top managers to establish company policies
Leads the selection, development and evaluation of personnel to ensure the efficient operation of the function
Makes final decisions on administrative or operational matters and ensures operations effective achievement of objectives
Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company and its objectives
Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people
Ensures that budgets and schedules meet corporate timelines
Must have strong negotiation skills with vendors and management to influence senior leaders regarding matters of significance to the organization
Directs and controls the activities of a broad functional area through partnership with cross-functional department managers within the company
Qualification
Required
Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)
BS/MS degree with 12+ years or PhD with 10+ years of industrial experience in small molecule pharmaceutical development
Expertise in HPLC method development is essential
Additional experience in techniques such as gas chromatography, NMR, mass spectrometry, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, and/or FTIR are important
Solid understanding of phase-appropriate approaches to control strategy, method validation, and retest/expiry
Experience in analytical development and validation for drug substances, starting materials, synthetic intermediates, and solid oral drug products
Experience in management of analytical activities at CDMOs/CROs
Experience managing stability programs, reference standards, and retest/expiry
Familiarity with ICH guidelines, cGMPs, and pharmacopeial chapters
Experience in OOT/OOE/OOS management, deviation management, and change control
Ability to critically interpret data and articulate technical concepts in multidisciplinary settings
Ability to ensure assigned activities are completed in satisfaction of project timelines
Strong interpersonal skills that foster collaboration within and outside of the organization
Ability to travel domestically and internationally
Preferred
Excellent teamwork and collaboration skills
Proficient with Microsoft Office
Able to build effective working relationships throughout the organization internally and externally to achieve goals
Flexibility and willingness to solve problems that fall outside of immediate area of expertise
Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail
Work independently in an interdisciplinary, fast-paced, often changing environment
Committed to the values of integrity, accountability, transparency, and drive
Company
Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company.
51-200 employees
H1B Sponsorship
Corvus Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$446.7MKey Investors
EcoR1 CapitalRock Springs CapitalOrbiMed
2026-01-21Post Ipo Equity· $201M
2024-05-02Post Ipo Equity· $30.6M
2021-05-05Post Ipo Equity· $10M
Leadership Team
J
Jeffrey S. Arcara
Chief Business Officer
Recent News
legacy.thefly.com
2026-01-23
Sherwood News
2026-01-22
2026-01-22
Company data provided by crunchbase