Biomanufacturing Leader

Job Title: Principal Scientist Cell Line Development

About Resilience: Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made.

Job Summary: We're seeking a highly experienced and scientifically-driven Principal Scientist Cell Line Development to lead the mammalian Cell Line Development function for the Biologics, Vaccines, and Gene Therapy modalities.

Key Responsibilities:

• Lead the flawless execution of customer projects from technical development, through manufacturing operations, and culminating in the successful preparation of regulatory submissions.
• Provide technical, tactical, and scientific leadership to the cell line development team.
• Execute or oversee the execution of protocols to generate and characterize cell lines.
• Define and implement the strategy for regulatory compliance.
• Define and implement state-of-the-art technology to develop cell lines, pools, and clones.
• Determine required experiments for AAV, LVV, or other viral gene stable incorporation.
• Determine required experiments and approaches for upstream processes, including stable and transient transfections, selections, clone isolation, screening, scale-ups, and fed-batches in shake flasks.
• Responsible for developing and performing small-scale bioreactor runs for cell testing and production.
• Perform molecular biology, including recombinant cloning and preparation of expression vectors, RT-PCR, and other standard or CRISPR-based molecular biology techniques.
• Assist in data analysis related to upstream processes and assays and experimental outcomes.
• Assist in research, product, and process development for current and novel work.
• Participate in maintaining capabilities, databases, laboratories, equipment, and supplies in the areas of protein engineering, cell biology, and cell line development.
• Write and review R&D protocols, SOPs, reports, and other product development and R&D documents.

Requirements:

• Extensive cell line development experience.
• A history of effectively contributing to the development of drug candidates.
• Significant drug development experience, clinical or commercial manufacturing exposure/familiarity, and track record of success leading multiple projects or programs.
• Excellent communication/presentation skills and scientific/technical writing skills.
• Demonstrated successful experience with working in interdisciplinary and cross-cultural teams.
• Proven track record of creativity, problem solving, and productivity in projects.

Preferred Qualifications:

• PhD in Chemistry, Bioengineering, or a related discipline preferred, with deep technical experience in biomanufacturing/biotech/pharmaceutical.
• Previous supervisory experience.
• Consultative approach in partnering with customers to optimize solutions.
• A recognized drug development leader, with breadth of exposure across the spectrum of CMC functional responsibilities.
• Brings a track record of creative problem solving - particularly when no or minimal precedent.
• Ability to convey mission and ideas to diverse audiences, including business development partners and internal stakeholders.