Principal Scientist, Cell Line Development

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Resilience is seeking a highly experienced and scientifically-driven Principal Scientist - Cell Line Development, who will lead the mammalian Cell Line Development function for the Biologics, Vaccines, and Gene Therapy modalities. This leader will play a critical role in revolutionizing the way drugs are developed and manufactured at Resilience. Reporting to the Head of Process Development - Boston, the Principal Scientist - Cell Line Development will be accountable for the flawless execution of the Cell Line Development activities, spanning mammalian cell line culture and development, vector construct development, mammalian cell line engineering, cell line characterization and stability testing, single cell cloning, as well as optimization of processes and assays. The Principal Scientist is also responsible for HEK 293 cell line engineering to generate an AAV or LVV packaging line, vector design, evaluation of production and gene incorporation. In addition, this role is responsible for developing the strategy to achieve implementation of stable pools and cell lines, as well as, supporting the regulatory advancement of fully integrated cell lines. This leader will be responsible for driving a deeply scientific and customer enabling culture. A key aspect of the role will be the technical mentorship of the staff and the ability to raise their technical expertise through close interaction and mentorship. The successful candidate must have hands-on background in development and GMP implementation of cell lines and cell banks, knowledge of complex scientific principals and concepts in fields of cell biology, protein expression, molecular biology, and/or protein engineering, including plasmid design, CRISPR or transposase mediated GOI insertion, viral capsid production, stable and transient transfections, clone screening, small scale bioreactors, and DNA cloning and PCR.

Job Responsibilities

• Be accountable for 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.
• Executes or oversees execution of protocols to generate and characterize cell lines.
• Responsible for defining and implementing the strategy for regulatory compliance.
• Define and implement state-of-the-art technology to develop cell lines, pools and clones.
• Define required experiments for AAV, LVV, or other viral gene stable incorporation.
• Determine requiredexperiments and approaches for upstream processes, including stable and transient transfections, selections, clone isolation, screening, scale-ups, and fed-batches in shake flask.
• 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.
• All other tasks as needed or assigned by supervisor.

Minimum Experience

• 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 Experience, Education & 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.
• A track record of introducing improvements to relevant processes or operations and/or devising novel solutions to problems that served a roadblock.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.