Senior Director, CMC

National Resilience

National Resilience

Sales & Business Development
Waltham, MA, USA
Posted on Friday, September 22, 2023

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

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 $215,000.00 - $278,750.00. 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.