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.