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-drivenSenior Director of Analytical Development, who will lead the Analytical Development functions across the Biologics, Vaccines, Gene Therapy and Nucleic Acid technology areas. This leader will play a critical role in revolutionizing the way drugs are developed and manufactured at Resilience. Reporting to the VP & Head of Technical Development, the Senior Director of Analytical Development will be accountable for the flawless execution of our Analytical Development activities; spanning technical development, method transfer, manufacturing, product release and successful preparation of regulatory submissions. She/he will oversee and drive the teams of analytical scientists that manage the Analytical Development-related activities, for multiple projects. The Senior Director of Analytical Development scope will span programs across the Biologics, Vaccines, Gene Therapy, Cell Therapy or Nucleic Acid franchises. 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 Biologics, Vaccines, Gene Therapy (AAV & LVV), and Nucleic Acid modalities. Knowledge of Cell Therapy analytics is a plus.

The ideal candidate will work with the modality Technical Development Heads, 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 and strategic guidance in the development of a toolbox of functional assays that can progress to implementation as potency assays, with phase-specific qualification
Direct a seamless interface with operational teams to transfer 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
Collaborate with process development teams to ensure appropriate experimental design, sample analysis, and data interpretation
Develop and drive 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
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 COGM, 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
Work with Business Development team(s) to effectively manage relationships between the company and various collaborative partners

Minimum Requirements

Excellent communication/presentation skills and scientific/technical writing skills.
Proven track record of creativity, problem solving and productivity in projects
A recognized drug development leader, with breadth of exposure across the spectrum of CMC functional responsibilities
Thorough understanding of development processes in TR&D
Brings a track record of creative problem solving - 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
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
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
Advanced coaching and mentoring skills

Preferred Requirements

PhD in Chemistry, Bioengineering, or a related discipline preferred, with deep technical experience in biomanufacturing/ biotech/ pharmaceutical
15+ years Experience in Analytical Development or similar role

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 $220,000.00 - $280,000.00 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.