Director Analytical Development & Quality Control

Corvus Pharmaceuticals, Inc.; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Corvus Pharmaceuticals, Inc. seeks a seasoned pharmaceutical development leader to drive analytical method development and regulatory CMC activities for small molecule programs.

You will oversee method development, validation, QC testing, and stability studies, collaborating with CDMOs/CROs and cross-functional teams to mitigate risks and meet timelines. The role requires an advanced degree with 10+ years of industrial experience, strong expertise in HPLC, and excellent communication skills to

Qualifications

• Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field).
• 12+ years (or PhD with 10+ years) of industrial experience in small molecule pharmaceutical development.
• Expertise in HPLC method development is essential.
• Experience with GC, NMR, MS, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, FTIR.
• Familiarity with ICH guidelines, cGMPs, and pharmacopeial chapters.
• Experience in analytical development and validation for drug substances, starting materials, intermediates, and solid oral drug products.
• Experience in management of analytical activities at CDMOs/CROs.
• Experience managing stability programs, reference standards, and retest/expiry.
• Experience with OOS/OOE/OOT management, deviation management, and change control.
• Strong data interpretation and communication in multidisciplinary settings.
• Ability to travel domestically and internationally.

Responsibilities

• Characterize drug substance and product attributes and identify technical risks.
• Develop methods for analytical characterization of drugs and products.
• Manage method development, validation, QC testing, and reference standard programs.
• Oversee stability studies, forced degradation, and retest expiry strategies.
• Contribute to OOS/OOE/OOS investigations and data reviews.
• Author CMC sections of IND/IMPD/NDA/MAA regulatory documents.
• Lead and develop analytical development teams and coordinate CDMOs/CROs.
• Ensure regulatory timelines and corporate objectives are met.
• Collaborate with senior leaders to shape development strategies.
• Travel domestically and internationally as needed.

Skills

Negotiation

Interpersonal skills

Leadership

Collaboration

Problem solving

Education

Advanced degree in Chemistry/Pharmaceutics

BS/MS with 12+ years or PhD with 10+ years industrial experience

Tools

Microsoft Office

Job description

• 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.

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.