Director, Technical Operations

bit.bio is an award-winning spinout from the University of Cambridge. Our breakthrough technology combines synthetic and stem cell biology for the precise, efficient and consistent reprogramming of human cells used in research, drug discovery, and cell therapy.

At bit.bio, we are passionate about engineering human cells that will enable the medicine of the future. To do this we need talented and curious people who want to make an impact on the future of science and therapeutics.

As a team of individuals, we value science, collaboration, openness, curiosity and creativity. We are united by trust and respect for each other.

  • Location: Babraham Research Park, Cambridge
  • Type: Full time, permanent / 
  • Start: Immediate
  • Salary: Competitive / Hours: 40 p/w
  • Office based position

Your role in our team:

Reporting to the SVP, Technical Operations and Cell Manufacturing, the Director, Technical Operations has accountability for the successful technical transfer, process development, scale-up, supply chain, and cGMP manufacturing of our first clinical cell therapy. This will include active participation in the quality and regulatory oversight of this clinical product. The successful candidate will manage all technical operations for our first cell therapy product that deliver to a defined target product profile, clinical specifications, and eventual commercial plans.

This individual will be accountable for the successful planning and implementation of technical operations in support of Bit Bio’s clinical strategy priorities and objectives. This individual will be a key member and contributor to the first program team created by the company. This individual will be responsible for managing technical budgets and timelines, as well as communicating progress to Bit Bio’s leadership team. This is a hands-on role. 

Working closely with the SVP, Technical Operations and Cell Manufacturing, the Director, Technical Operations, will contribute to the development of infrastructure, processes and systems required to deliver cGMP manufacturing capabilities in support of bit.bio's clinical development activities.

Your key responsibilities will include:

  • Lead, direct and manage the technical operations function to meet, exceed and support business objectives for clinical cell therapies
  • Successfully execute the strategy and objectives for the technical operations function to meet the company’s clinical therapy goals in line with business priorities
  • As the CMC representative on the clinical program team, manage and plan budgets, projects, personnel and schedules to deliver according to desired outcomes and plans 
  • Collaborate with cross-functional stakeholders to select CDMOs, establish contracts oversee manufacturing partners and suppliers
  • Establish and maintain reliable and adaptable cGMP-compliant networks of CDMOs to develop robust manufacturing process across the clinical cell therapy portfolio
  • Design lean experiments to quickly drive process and analytical development knowledge
  • Guide the creation and phase-appropriate validation of analytical methods to release and characterize clinical cell therapy products
  • Effectively tech-transfer process and analytical information to CDMOs
  • Prevent and resolve technical operational issues (deviations, CAPAs, delays, etc.)
  • Lead the generation of SOPs, protocols, technical reports and batch records for process development and manufacturing activities
  • Coach, mentor and train direct and in-direct reports to build a high-performing and matrixed technical operations team
  • Drive strong collaboration and communication across functions: R&D, translational, clinical development, business operations, quality, regulatory, finance and commercial functions
  • Create and advance analytical capabilities and tools to shape the company’s mid- to long-range clinical sourcing strategies, capacity plans, inventory strategies and risk mitigation activities
  • Assist in the preparation of CMC regulatory documents
  • Assist in due diligence efforts, audits and site visits
  • Serve as person-in-plant (PIP) as needed for clinical manufacturing campaigns
  • Interface with quality and regulatory teams and support the company’s rigorous quality and regulatory systems and standards
  • Understand and efficiently communicate project status and risks, present data and strategy to program teams and leadership
  • Assist in the incorporation of knowledge of current regulations and guidance into company culture

You…

  • Have a BSc/MSc in Molecular Biology, Cell Biology, Biological Sciences or similar; or equivalent experience - PhD in Cell Biology, Stem Cell Biology or similar preferred; or equivalent experience
  • Are results oriented with demonstrable creative problem-solving skills under resource constraints and time pressure
  • Are able to apply innovative thinking to problem solving for novel challenges
  • An outstanding communicator across all levels within an organisation with strong influencing and negotiation skills
  • Have high expectations for performance and accountability for actions and results
  • Are a self-starter with an entrepreneurial mindset, a can-do mentality and high energy & drive to succeed
  • Are humble - sincere and secure - accepts own mistakes - prioritises team over personal goals
  • Are hungry - driven and proactive - goes above and beyond call of duty to achieve company results
  • Are smart - astute and persuasive - uses emotional intelligence to lead and inspire colleagues

With essential experience in…

  • Proven experience in the scale up and delivery of GMP produced clinical/cell therapies
  • Full knowledge of GxP principles and regulations. 
  • Deep understanding of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMPs; knowledgeable of FDA and other HA regulations and ICH Guidelines regarding the manufacture of cell and gene products. 
  • Quality compliance standards and risk management. 
  • Strong leadership and management skills in clinical therapy programs.
  • Demonstrable leadership skills in coaching, managing and mentoring direct and indirect reports
  • Demonstrable success of working effectively in complex matrix project team environment including external partners and customers
  • Excellent multi-tasking, analytical, organizational and leadership skills. 
  • Strong written and verbal communication skills. 
  • Ability to troubleshoot, identify root cause and systematically resolve problems.


...and possibly.....

  • Experience with cell & gene therapy
  • MBA and/or Masters in Operations
  • Experience in a clinical stage start-up biotech environment

More reasons to join us:

bit.bio provides a vibrant and dynamic work environment in an exciting, fast-moving time for biology. We work with cutting edge technologies and with our world-leading scientific advisory board. We conduct pioneering work with real-world impact.

We trust our people to make significant contributions early on with opportunities to be involved in projects that are key to the success and growth of our young company. We invest in people, creating opportunities for personal development in an inclusive multi-skilled team with ambitious goals that provide opportunities to learn on the job from each other.

Creativity and open minds are encouraged for everyone to contribute to the success of the company.

Apply now


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