Director, Materials & Biophysical Characterization
Job Description
The Materials & Biophysical Characterization group within Analytical Research & Development is seeking a highly motivated leader of a team interested in materials characterization with a passion for people development and interested in positively impacting our small molecule pipeline from discovery to launch. This team is accountable for delivering materials characterization methodologies and phase screening platforms to ensure successful advancement of molecules from discovery through development and commercial launch. While most materials will be small molecules, there is a need to advance capabilities and drive innovative approaches for physical characterization and crystallization of complex molecules and drug products involving synthetic peptides, oligonucleotides, drug-linkers in ADCs and small proteins.
Responsibilities:
- Provide strategic and technical leadership for all physicochemical characterization of pharmaceutical materials, including small molecule active pharmaceutical ingredients (API), drug linkers in antibody drug conjugates (ADCs), formulated drug products, process, and drug-product intermediates for all new products.
- Sponsor the implementation of new technologies and platforms in materials characterization.
- Recruit and develop talent.
- Be proactive in resource planning, risk assessment strategies, and budget management as necessary (including merit and promotion planning).
- Maintain a strong network internally and across the external academic and regulatory community, advance a culture of scientific excellence, Good Manufacturing Practice (GMP) and compliance mindset, and collaborate with various partners and stakeholders across the network.
Qualifications:
- PhD in Physical Chemistry, Materials Science, Pharmaceutics, Chemical Engineering, Chemistry or a related field with 8+ years of relevant experience in the pharmaceutical industry; MS with 10+ years of relevant experience; BS with 14+ years of relevant experience.
- Experience in late-stage development, including development, validation and/or transfer of methods for API and intermediates in support of drug substance manufacture and authoring of relevant sections of regulatory filings, preferred.
- Strong technical expertise in physical chemistry and materials characterization as well as experience managing scientists.
- Highly self-motivated, strong leadership and strong mentorship skills, excellent written and oral communication abilities.
- Effective collaborator on multidisciplinary teams and demonstrate flexibility in adapting to change in a fast-paced, dynamic environment.
- Passionate people manager who is committed to talent development of their team to capitalize on the unique capabilities and strong scientists in the group.
Required Experience and Skills:
- Excellent verbal and written communication skills, demonstrated creativity and innovative problem solving, strong interpersonal and collaborative skills.
- Demonstrated ability in leading cross-functional teams and influencing team strategy and decision-making.
- Proven talent development skillsets.
- Experience in physicochemical characterization of drug substance, intermediates and drug product, crystallization, form selection and/or solid-state characterization of organic small molecules.
Preferred Experience and Skills:
- Encourages innovative thinking/risk taking and eliminates obstacles to implement change.
- Experience in late-stage development, including API attributes definition, solid-state methods development, validation and/or transfer in support of drug substance manufacture, and authoring of relevant sections of regulatory filings.
- Experience in excipient, drug product intermediates, formulation characterization including physical properties.