Senior Director, CMC
Resilience
Position Summary & Role
We are seeking a Senior Technical Leader who will lead our Chemistry, Manufacturing, and Controls (CMC) teams and partner technical projects, in revolutionizing the way drugs are developed and manufactured. Reporting to the VP & Technical Head of Biologics and Vaccines, the Senior Director of CMC 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 one or more projects. The 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, this technical 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 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 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 forecast, proposal preparation and tracking of cost
Ensure costs and cost awareness in all assigned projects and/or platforms
Interpret results, evaluate data, draw relevant conclusions and write reports
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 hybrid, site/remote role and may require up to 25% travel
Preferred Experience, Education & Qualifications
PhD in Chemistry, Bioengineering, or a related discipline preferred with deep technical experience in biomanufacturing/ biotech/ pharmaceutical
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 Technical R&D
Brings a track record of creative problem solving - particularly with 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 as roadblocks
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