Director/Senior Director, Analytical Development and Quality Control

Location: Burlingame, CA

Role and 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.
  • Has overall control of planning, staffing, budgeting, managing expense priorities and recommending and implementing changes to methods.

Qualifications and Education Requirements

  • 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 Skills:

  • 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.

Salary range: $170,000 - $230,000 annually

If you are interested, please submit your resume to careers@corvuspharma.com