Director, GMP QC & Analytics
at Bit Bio
Cambridge, UK
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 - part home-based flexibility
Your role in our team:
Reporting to the SVP, Technical Operations and Cell Manufacturing, the Director, GMP QC & Analytics has accountability for the successful development, transfer, adaption, and phase appropriate validation of analytical assays for our first clinical cell therapy. This will include active participation in the quality control and regulatory oversight of this clinical product. The successful candidate will manage all QC and analytical development activities for our first cell therapy product that deliver to a defined target product profile, clinical specifications, and eventual commercial plans. In addition, the candidate will manage ongoing QC for the manufacture of our commercial research cell products.
This individual will be accountable for the successful planning and implementation of quality control operations and GMP analytical development in support of Bit Bio’s clinical strategy priorities and objectives, as well as the ongoing QC for our commercial research cell products. This individual will be responsible for managing analytical 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, GMP QC & Analytics, will contribute to the development of quality control and analytical development 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 QC and analytical development functions to meet, exceed and support business objectives for clinical cell therapies
Successfully execute the strategy and objectives for the QC and analytical development functions to meet the company’s clinical therapy goals in line with business priorities
Manage and plan budgets, projects, personnel and schedules to deliver according to desired outcomes and plans
Oversee raw materials testing, in-process and finished product testing, stability testing, method transfer and validation, instrument and software qualification, QC data integrity, sample management and QC document management
Collaborate with cross-functional stakeholders to select CDMOs and analytical CROs, establish contracts oversee manufacturing partners and suppliers
Work cross-functionally to identify and mitigate potential quality risks
Drive continuous improvement initiatives to ensure that the QC and analytical development functions meet key performance indicator goals
Develop and execute the QC strategy for Bit Bio’s clinical and commercial research cell products
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 analytical information to CDMOs
Prevent and resolve analytical operational issues (deviations, CAPAs, delays, etc.)
Lead the generation of technical reports and analytical methods 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
Are a seasoned CMC professional, with significant industry experience, including several years of developing and manufacturing complex advanced therapies in a cGMP environment
Are able to demonstrate leadership skills in coaching, managing and mentoring direct and indirect reports
Have demonstrable success of working effectively in complex matrix project team environment including external partners and customers
Are results oriented; able to demonstrate creative problem-solving skills under resource constraints and time pressure; able to apply innovative thinking to problem solving for novel challenges
Are an outstanding communicator across all levels within an organisation; have strong influencing and negotiation skills
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 analytical development and QC of GMP produced gene and cell therapies
Strong leadership and management skills in clinical therapy programs.
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
Excellent multi-tasking, analytical, organizational and leadership skills.
Proven success anticipating industry trends and regulatory requirements to manage business risk, compliance, and sustainability
Experience managing all aspects of a biologically-based manufacturing network including internal facilities and contract manufacturers
Experienced in the Implementation and ongoing management of the improvement of analytical methodology and approach, e.g. Lean, Six Sigma.
Specific process science and validation expertise will be critical to build a scalable and registration-ready platform.
Strong written and verbal communication skills.
Ability to troubleshoot, identify root cause and systematically resolve problems
...and possibly....
PhD Cell Biology, Stem Cell Biology or similar; or equivalent research experience
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.
For information on how we will manage your data please see our Candidate Privacy Notice- https://www.bit.bio/candidate-privacy-notice