Associate Director/Director, Biologics Product Analytics-CMC
Exton, PA (Research)
Roles and Responsibilities:
- Direct activities of the Biologics Product Analytics department for method development, validation, tech transfer, product characterization, impurity profiling, routine and stability testing across varieties of biologics products.
- Train, develop staff, and manage budgets. Balance resource allocation to project priorities.
- Under strategic direction of BDMS leader, lead the creation of new service portfolios for emerging biotherapeutics.
- Prepare project proposals, protocols, reports, Certificate of Analysis, investigation reports, and generate cGMP documents.
- Manage projects from initiation to completion and ensure the projects are on time, on budgets, and meeting pre-established quality standards.
- Closely interact with clients through various means of communication and ensure high client satisfactions.
- Engage and influence the broader analytical community through publications, posters, webinars, and oral presentations.
- PhD in Biological Science, Biochemical Engineering, or related discipline with 5+ years analytical development experience, or MS with 10+ years analytical development experience for biologics. Job title to be commensurate with the experiences and qualifications.
- Established track record of success in analytical method development for biologics such as recombinant proteins and monoclonal antibodies. It is a plus to have cell and gene therapy product characterization, cell-based assay, and flow cytometry experience.
- Experience planning and coordinating analytical projects across multiple stakeholders both internally and externally.
- Experience working in a GMP and GLP environment.
- Strong knowledge of global regulatory environment with the prior experience in writing analytical sections for INDs and BLAs.
- Experience leading teams, managing labs and budgets.
- Prior experiences working in Contract Service industry is a plus.
- Excellent communication, organization, and team building skills.
Employment at Frontage Labs:
Frontage Labs offers competitive salary and generous benefits including paid vacations, health insurance, 401K, disability insurance, and many others. On top of these benefits, we offer many opportunities to help you advance your career. So come, and join us today!