Senior Scientist, Analytical 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 (Resilience US, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients' lives.

For more information, visit www.resilience.com.

Position Summary & Role

We are seeking a talented Senior Scientist of Analytical Development for Resilience's Franchises on established and emerging modalities. The responsibilities of this individual will include setting up analytical labs, building up analytical groups with hands-on approaches, overseeing daily operations and establishing industry leading analytical capabilities.

Job Responsibilities

• Lead and manage a group of analytical scientists to develop various analytical methods for multiple modalities, including mAbs, recombinant proteins, viral vectors, VLPs, and nucleic acids to support all aspects and stages of drug substance and drug product development including in-process testing, release testing, product characterization, and phase appropriate method qualification and transfer into the GMP sites.
• Ensure efficient planning and execution including daily testing operations.
• Work with analytical groups at other sites to drive continuous improvement and operational excellence.
• Implement the most rigorous scientific standards for the analytical development function and become industry leader in key areas such as cell-based bioassays, functional ELISA assays, assays for process-related impurities, etc.
• Lead in customer interaction and keep custom routinely informed via various update venues.
• Develop and manage top notch analytical development teams in terms of technical capability and quality reputation.
• Drive the implementation of various innovative analytical technologies and strategies to become industry leaders in innovation.

Minimum Qualifications

• Expertise with the current analytical techniques and cell-based biological assays and/or immunochemical assays, various PCR analyses, flow cytometry, molecular binding, and enzymatic activity, etc.
• Proven track record of developing fit-for-purpose analytical methods and participating in method qualification/validation processes
• Demonstrated successful experience with working in interdisciplinary and cross-cultural teams
• Ability to convey mission and ideas to diverse audiences, including business development partners, and internal stakeholders

• Ability to fluidly flex between high level strategy and detailed tactics and works well in the grey zone
• Strong analytical mind-set and ability to quickly assess large amounts of information and distill into key messages and actions
• Proven abilities in leadership and team management.

Preferred Experience& Qualifications

• PhD or MS in biological sciences, molecular biology, biochemistry or a related discipline with 6+ or 10+ years' experience, respectively, in analytical development at various stages in a biopharmaceutical setting
• Knowledge with other common analytical techniques such as electrophoresis, HPLC, spectroscopic analysis, etc.
• Knowledge and direct experience with CMC analytical requirements for regulatory filing.
• Solid understanding of cGMPs, USP and ICH guidelines, and industry best practices.
• Experienced in driving new analytical technology development and implementation.
• Proven abilities in leadership and team management.
• Strong oral and written communication skills.

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.