Senior Director CMC

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

The Opportunity

Resilience is seeking a Technical Project Leader who will lead our CMC teams and partner technical projects, in revolutionizing the way drugs are developed and manufactured. Reporting to the VP & Head of Technical Development, the Technical Project Leader 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. She/he will oversee and drive a cross-functional team of technical developers/leaders to manage all technical project related activities, for multiple projects. The Technical Project Leader scope may span programs across the Biologics, Vaccines, Gene Therapy, Cell Therapy or Nucleic Acid franchises. In addition, and to ensure connection to the scientific core of the company, the Technical Project Leader may also be asked to perform a concurrent technical function lead role on the team and/or coordinate interdisciplinary projects and teams.

The ideal candidate will work with the Heads or Process Development, 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 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
• Lead and manage all technical project activities and apply scientific/technical expertise to address complex R&D issues
• Actively support Technical R&D strategies and goals by leading and participating in cross-functional teams
• Work closely and collaboratively with Manufacturing, Quality and Regulatory colleagues to establish highly efficient technology transfer and to reduce COGM, while significantly increasing operating efficiencies via designed process & analytical platforms
• Facilitate scientific programs, interdisciplinary projects and teams; as assigned
• 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
• Support and work with functional management to assign associates in specific projects and/or networks
• Coach the team(s) on target dates and priorities. Proactively contribute to budget forecasts, proposal preparation and tracking of cost
• Ensure costs and cost awareness in all assigned projects and/or platforms
• Optimize scientific/technical related activities in assigned projects, networks and/or platforms
• Work with Business Development team(s) to effectively manage relationships between the company and various collaborative partners
• Establish close working relationships with other Technical Project Leaders to synergize shared technologies and help elevate Resilience as an enterprise
• This will be a site role (based in Boston or Alachua) and may require up to 25% travel

Minimum Qualifications

• Deep technical experience in biomanufacturing/ biotech/ pharmaceutical
• Significant experience in biopharmaceutical drug development
• Experience in both early and late-phase product development and/or launch support
• 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
• 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 Technical Development 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 Qualifications

• PhD in Chemistry, Bioengineering, or a related discipline preferred, with deep technical experience in biomanufacturing/ biotech/ pharmaceutical
• 15+ years of experience in biopharmaceutical drug development
• This position may also include the following conditions:

Based in Boston or Alachua site office

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

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.