Director, Analytical Development Cell Therapy

National Resilience

National Resilience

East Norriton, PA, USA
Posted on Monday, June 3, 2024

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 (National Resilience, 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.

The Opportunity

Resilience is seeking a highly experienced and scientifically-driven and client-focused Director of Analytical Development, who will lead the Analytical Development function for the Cell Therapy modality. This leader will play a critical role in revolutionizing the way drugs are developed and manufactured at Resilience. Reporting to the Head of Process and Analytical Development – Cell Therapy, the Director of Analytical Development will be accountable for the flawless execution of the Cell Therapy Analytical Development activities (internal and client-focused); spanning technical development, method transfer, manufacturing, product release and successful preparation of regulatory submissions. She/he will oversee and drive a team of analytical scientists that manages the Analytical Development-related activities, for multiple projects. 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 molecular, physical-chemical, and bioassay analytics, spanning the needs of the Cell Therapy modality.

The ideal candidate will work with the Head of Process and Analytical Development -Cell Therapy, customers, and internal scientific leaders to design and implement technical strategies which deliver the latest scientific and analytical innovations to our technical development and manufacturing infrastructure, network and client partners. We are seeking an experienced drug development leader to play a key role in coordinating and delivering successful customer and internal programs. This individual will be a team leader that motivates employees to execute our mission and nurtures the development of scientific talent into world class drug development teams.

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 team in the development, qualification, and implementation of innovative, robust, cost-efficient analytical capabilities that are clearly tied to business, client, and scientific requirements
  • Lead a team of technical and operational group leaders and provide day-to-day support, career development and mentorship
  • Coordinate the alignment of the overall analytical function, with other site AD leaders, to define work processes that maximize efficiency, predictability, and velocity
  • Provide technical, tactical, and scientific leadership to the team in the development, qualification, and implementation of innovative, robust, cost-efficient analytical capabilities that are clearly tied to business, client, and scientific requirements
  • Lead a team of technical and operational group leaders and provide day-to-day support, career development and mentorship
  • Provide technical and strategic guidance in the development of a toolbox of functional assays that can progress to implementation as potency assays, with phase-specific qualification
  • Provide input into the advancement of molecular analytical methods such as next generation sequencing and single cell PCR, and their applications to the characterization of cell therapy products
  • Direct a seamless interface with operational teams to transfer in analytical capabilities and to address any problems or unexpected results in manufacturing and QC
  • Interface with candidate clients to highlight company capabilities and approaches; author and provide critical technical feedback on client project proposals
  • Provide representation to CMC teams for collaborative client projects for strong communication, strategy setting, and execution
  • Collaborate with process development teams to ensure appropriate experimental design, sample analysis, and data interpretation
  • Lead the gathering and analysis of data trends including assay controls and batch-specific data
  • Direct authoring and review of technical and scientific documents, including (but not limited to): study protocols and reports, validation documents, SOPs, regulatory submissions, and test methods
  • Serve as a technical beacon for the team by maintaining expertise, reviewing publications, attending conferences and networking across other Resilience sites to support an analytical development community of practice
  • Foster a culture of innovation and an environment of technical mastery at all levels
  • Collaborate with other site leaders to define work processes that maximize efficiency, predictability, and velocity
  • Manage resource allocation and set priorities and objectives for the team to ensure timely completion of client and internal technology development deliverables
  • Work closely and collaboratively with Process Development, Quality and Regulatory colleagues to establish highly efficient technology transfer and to reduce COGS, while significantly increasing operating efficiencies via designed process & analytical platforms
  • Assist in developing long-term strategies on science and technologies
  • Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members
  • Ensure quality, quantity and timelines in all assigned projects and/or platforms

Minimum Qualifications

  • Thorough understanding of development processes in TR&D
  • Proven track record of creative problem solving and productivity in projects - particularly when no or minimal precedent
  • Significant drug development experience, clinical or commercial manufacturing exposure/familiarity, and track record of success leading multiple projects or programs
  • 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
  • Appreciation for the design, organization and execution of a successful R&D approach and working knowledge of regulatory, commercial, and business aspects of the biotech industry
  • A track record of successfully developing drug candidates; introducing improvements to relevant processes or operations and/or devising novel solutions to problems that served a roadblock
  • 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

Preferred Qualifications

  • PhD, MS or other degree in Biotechnology, Cell Biology, Biochemistry, Chemical Engineering, or a related discipline with 10+ years relevant industry experience
  • Excellent communication/presentation skills and scientific/technical writing skills.
  • A recognized drug development leader, with breadth of exposure across the spectrum of CMC functional responsibilities
  • A leader of leaders who is passionate about mentorship, culture, and nurturing the development of scientific talent, with direct experience leading high-performing teams
  • Consultative approach in partnering with customers to optimize solutions

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.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $160,000.00 - $235,000.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.