Director - CMC Lead
Resilience
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. 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.
Resilience is seeking a technical project leader who will lead our CMC teams in revolutionizing the way drugs are developed and manufactured for our company’s partners. Reporting to the VP & Technical Head of Biologics and Vaccines, the CMC Lead will be accountable for the flawless execution of our CMC activities for customer projects, spanning technical development, technology transfer, manufacturing, product release and successful preparation of regulatory submissions. In this role, you will oversee and drive a cross-functional team of technical leaders and staff to manage all technical project related activities for a portfolio of client projects. The CMC Lead will initially focus on Biologics and Vaccines programs but may also be called on to lead programs across Resilience’s Gene Therapy, Cell Therapy and/or Nucleic Acid franchises. To promote connections with the scientific core of the company, the CMC Lead may also serve as a functional lead for a CMC technical team and/or coordinate other interdisciplinary projects and teams as needed.
The successful candidate will work with the franchise Technical Heads, customers, and internal scientific leaders to design and implement technical strategies which deliver the latest scientific, engineering and manufacturing innovations to our technical development and manufacturing infrastructure, network, and client partners. We are seeking an experienced drug development leader who will play a key role in coordinating and delivering successful customer and internal programs. This individual will be a team leader who motivates employees to drive the technical execution of Resilience’s mission and nurtures the development of world-class scientific talent.
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
Lead and manage all technical project activities, applying scientific/technical expertise to address complex R&D issues and optimize technical activities across cross-functional teams
Partner with Manufacturing, Quality and Regulatory colleagues to execute highly efficient technology transfers, reduce COGM, and improve operating efficiencies
Facilitate scientific programs, interdisciplinary projects and teams; as assigned
Assist in developing long-term strategies related to CMC science and technologies
Hold accountability for quality, quantity and timelines across assigned projects and/or platforms, proactively communicating any issues to the appropriate team members and management
Collaborate with functional management to manage team workload across programs/projects and/or networks, coaching the team on priorities and timelines as needed.
Proactively contribute to budget forecast, proposal preparation, ensuring cost awareness in all assigned projects and/or platforms
Interpret results, evaluate data, draw relevant conclusions and write reports.
Collaborate with Business Development team to effectively manage relationships with Resilience’s partners
Establish close working relationships with other Technical Project Leaders to synergize shared technologies and help elevate Resilience as an enterprise
Travel (up to 25%) to client meetings and sites across the Resilience network as needed in support of project goals
Required Qualifications
In-depth technical experience in the biomanufacturing, biotech, and/or pharmaceutical industry with an appreciation for the design, organization and execution of a successful R&D approach, exposure to clinical and/or commercial manufacturing, and working knowledge of the regulatory, commercial, and business aspects of the industry
Recognized drug development leader with breadth of experience across the spectrum of CMC functional responsibilities and track record of success leading multiple projects or programs
Experience in driving process improvement, operational efficiency, and/or creative problem-solving to remove roadblocks in a development setting
Experience in partnering with customers to optimize solutions through a consultative approach
Demonstrated success in partnering with interdisciplinary and cross-functional teams
Excellent communication/presentation skills and scientific/technical writing skills, with experience creating communications for diverse internal stakeholders and business development partners
Experience promoting data-driven decision-making by distilling large amounts of information into key messages and actions
A leader of leaders with strong experience in mentorship, promoting a positive culture, and nurturing the development of scientific talent
Ability to flex between high level strategy and detailed tactics to deliver successful outcomes
Preferred Qualifications
PhD in Chemistry, Bioengineering, or a related discipline
Experience leading high-performing teams of direct reports
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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 annualized base pay hiring range for this position is $160,000.00 - $235,000.00. 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.