Scientist/Senior Scientist, Technical Operations

Location: Babraham Research Park, Cambridge

Type: Full time, permanent 

Start: Immediate

Salary: Competitive / Hours: 40 p/w

Office based position - hybrid working available

Your role in our team:

Reporting to the Director, Technical Operations, the Senior Scientist, Technical Operations has accountability for the successful technical transfer, external process development, scale-up, supply chain, and cGMP manufacturing of the second generation, commercial-enabling version 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 the technical operations for the second generation, commercial-enabling version of our first cell therapy product that deliver to a defined target product profile, clinical specifications, and eventual commercial plans. The technical operations for this project will include the development of upscaled, automated drug product equipment to better enable the commercialisation of the product. This individual will be responsible for managing technical budgets and timelines, as well as communicating progress to Bit Bio’s technical operations and leadership team. This is a hands-on role. 

Your key responsibilities will include:

• Manage the later-stage, commercial-enabling technical operations to meet, exceed and support business objectives for clinical cell therapies.
• Successfully execute the strategy and objectives for the later-stage, commercial-enabling technical operations function to meet the company’s clinical therapy goals in line with business priorities.
• 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.
• Effectively tech-transfer process information to CDMOs.
• In collaboration with technical partners, develop and engineer upscaled, automated drug product equipment to better enable commercialization of clinical cell therapies.
• 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 maintain 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.
• 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 strong industry experience, and proven experience of developing and manufacturing complex advanced therapies in a cGMP environment.

With essential experience in…

• 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, organisational and leadership skills. 
• Strong written and verbal communication skills. 
• Ability to troubleshoot, identify root cause and systematically resolve problems.
• Proven experience in the scale up and delivery of GMP produced cell therapies.
• Managing aspects of a biologically-based manufacturing network including internal facilities and contract manufacturers.
• Management of clinical products ensuring quality supply.
• Implementation and ongoing management of manufacturing process improvement 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. 
• Successfully anticipating industry trends and regulatory requirements to manage business risk, compliance, and sustainability.

...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. Cell & gene therapy experience is preferred.