- Define, deliver and optimize the employer value proposition with the Marketing and Commercial teams on strategy and tactics. Determine how it will fit into our key account set ups as a CDMO and how we engage with the biotech industry, and how we will continue to harmonize the Marketing and Commercial functions. | - Operate for unprecedented delivery to ensure we deliver in the business for our Program Management operations. | - Lead for the future on modality and collaborate with our Business Development team on where the Company expands business; perform gap analyses to determine where the Company can become more competitive and how we strengthen our overall business strategy. | - Supporting development and implementation of dedicated marketing and commercial strategies that align with the overall business goals and ensure a robust pipeline that can fill the Value Stream capacity (short, mid, and long term). This includes: | - Competitive value proposition based on our corporate narrative and value messaging targeting the right customer segments. | - Marketing strategy and assessment of competitiveness in the market | - Commercial strategy and go to market strategy based on customer segmentation. | - Ongoing strategic commercial dialogues with key partners and commercial pipeline | - Insight on segmented customer needs as well as actual and potential business synergies or dependencies. | | - Creating and maintaining full overview through value stream maps and capacity understanding of operational footprint along S&OP overview to ensure this. | - Driving P/L (Revenue, ROS, PM, EBITDA etc.) transparency and oversight as well as continued financial performance improvement. | - Tracking operational performance to ensure high customer trust and satisfaction. | - Identifying areas for improvement and ensuring that cross-functional Value Stream input and priorities (opportunities, risks, and challenges etc.) are reflected in innovation and business development strategies. | - Ensuring that all marketing as well as commercial efforts are customer-centric and deliver value to the target audience. |
Initially the job role will be acting as QA on the implementation of the new manufacturing facility, working on implementing new systems, processes and procedures, once the manufacturing facility is live and operational it will be transitioning to a business as usual role proving QA oversite on the manufacture of GMP products to ensure compliance throughout the process life cycle. | | - Knowledgably administer, maintain, and continuously improve any assigned QA systems, which may include, Document Control and Issue, Change Control, Events Deviations & Non Conformances (Trackwise) Root cause analysis, CAPA’s, Qualification and Validation, Materials Assurance, Auditing and Training. | - Evaluation of data with recommendations for decision making made to QA Management. | - Identification and assessment of risk with appropriate escalation. | - To act as Quality Representative including verbal and written communication in customer program/project meetings. | - Operate core QA events and minor deviations. | - Document writing and review processes as instructed by QA Management. | - Ensure self has no overdue training, or site actions. | - Train staff in own and other areas as required in specific tasks related to job role
- Manage the compliant delivery of designated elements of the business Sales and Operations Plan (S&OP) | - Build and maintain good working relationships with key stakeholder functions and any other departments/individuals as required | - Evaluation of recommendations and make final decisions, but where appropriate identify escalation requirements with further recommendation to senior management | - Identification, assessment and mitigation of risk with escalation of high residual risk | - Ensure self and team (including line reports) have no overdue training, or site actions. Support other QA teams and other functions within area of direct influence, in completion of site actions | - Manage, motivate, train, and coach, any direct reports to ensure assigned Quality Assurance (QA) and personnel development objectives are achieved within agreed time-scales. Identify potential candidates for succession plans | - Able to coach/train personnel of non-QA roles, in the application of GMP Principles including the underlying rational of those principles | - Demonstrate Subject Matter Expertise (SME) in more than one QA System
- Knowledgably administer, maintain, and continuously improve any assigned QA systems, which may include, Document Control and Issue, Change Control, Events Deviations & Non Conformances (Trackwise) Root cause analysis, CAPA’s, Qualification and Validation, Materials Assurance, Auditing and Training | - Evaluation of data with recommendations for decision making made to QA management | - Identification and assessment of risk with appropriate escalation | - To act as Quality Representative including verbal and written communication in customer program/project meetings | - Operate core QA events and minor deviations | - Document writing and review processes as instructed by QA Management
Commercial Development Manager will support the Executive Director Commercial Development in Biologics with developing, maintaining and execution of strategies to strengthen the Biologics commercial pipeline across Europe. | | - Independently prospect in agreed territories, including the identification of key target customers and formulation of a sales strategy/activity plan for that defined territory in order to build strong personal relationships with customers and meet assigned sales targets | - Provide input into the team commercial strategy for a given geography/service offering and assist in monitoring delivery versus plan as required | - Contribute to the implementation of the marketing strategy by independently attending exhibitions and conferences | - Have a high level of visibility within a given territory and be seen as a trusted external face of the organisation. | - Arranging and leading face-to-face meetings with prospective customers, either visiting them or hosting meetings at FDB sites globally | - Lead the proposal process for new projects, ensuring timely delivery and review of the proposal by the relevant internal stakeholders. | - Recommendations on the proposal content (scope/positioning/presentation) and pricing for consideration by the relevant stakeholders. | - Lead the negotiation of commercial agreements for process development and manufacturing projects, with support from the VP, Commercial Development. This involves influencing internally and externally and agreeing terms which include intellectual property, manufacturing rights, liability and payment terms. | - Build and maintain a good working knowledge of the market/competitive landscape in a given territory. | - Have a deep knowledge of the market/competitive landscape for a given territory/service offering and be proactive in ensuring that pertinent information is disseminated to the wider commercial organisation on a regular basis
- Facility leadership: To represent Quality within the manufacturing asset with daily GEMBAs, regular inspections and assessment of all areas used for GMP manufacturing | - Facility ownership and execution: Responsible for the Quality assessment of standard adherence within the manufacturing facility. Assess that the required clean room standards are adhered to, is fit for manufacturing GMP product within and in accordance with the FDBK PQS and the relevant global regulations. Stop manufacturing activities if assessment highlights serious GMP breaches and escalate to Senior QA and Operational Management | - Facility communication: To identify, communicate and escalate identified operational risks in a timely manner and to resolve or mitigate or minimise when possible | - Facility audits/inspections: To ensure that facility documentation (for example logbooks, forms) are continuously improving and are audit/inspection ready at all times, with operational risks minimised whenever possible. Support the satisfactory completion of client audits and regulatory inspections. Support project and site inspection readiness activities and to host or present during client audit and regulatory inspections as directed | - Investigations champion: To lead, aid or approve environmental, utility or cleaning investigations. To assess any environmental or utility breaches and/or adverse trends and manage the reporting and assessment of risk for said breaches or trends. Ensure that the correct investigational pace is set and that appropriate tools are used e.g. fishbone, RCA, 5-Whys. To ensure that outcomes are valid and that CAPA actions are appropriate | - Quality documentation: To effectively manage the generation and approval of key Quality documentation to support manufacture of product. To ensure that the documentation is fit-for-purpose and is designed to minimise errors
The work we do at FUJIFILM Diosynth Biotechnologies (FDB) changes lives, and our united passion for advancing tomorrow’s medicines – our Genki – will always be our driving force. Whilst working as the VP of Key Account Management in our global Commercial Development team, you’ll be joining other motivated individuals who fuel one another’s passions and embrace every day as an opportunity. We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the CDMO of choice for our customers - and the employer of choice for our talent. | | Essential Functions: | - Work with the SVP, Commercial to design and implement strategies to support the growth of FDB aligned with the near-, mid- and long-term plans. | - Provide effective leadership and management of the KAMs team to ensure they develop and nurture deep relationships with Pharma and Key accounts to identify trends and needs of the market and provide feedback to the wider FDB team to support continued investment and business diversification. | - Management of high profile Pharma accounts which require senior support. | - Coach and mentor the Executive Directors, KAMs to ensure they excel in their roles and therefore provide great customer service to all key accounts. | - Take a pro-active role in the Commercial Leadership Team to ensure our strategies continue to be aligned with our FDB goals and we are keeping up to date with new trends and market data, amending the strategy as required. | - Work with the broader FDB teams to ensure effective support to the KAMs team. | - Support with recruitment, on-boarding, succession planning and career development of the KAMs team. | - Act as a point of escalation for customer complaints/concerns. | - Negotiate and re-negotiate commercial contracts with accounts including MSAs, CSAs, Scope of work, equipment, and capital purchases. | - Lead major site customer visits. | - Ensure we have effective cover for all key accounts across the network. | - Ensure cross functional collaborative and project team leadership assignment consistent with personal strategic, operational, and technical leadership. | - Attend commercial events to promote the work of FDB and support lead generation. | - All other duties as assigned.
The Principal Production Technologist role is a leadership role within Manufacturing . | | Duties include: | - Management of manufacturing team | - Technology Transfer | - Root Cause Analysis | - Ensuring efficient organisation of activities to ensure manufacturing schedule is achievable. | - Monitor production status to ensure delivery | - Strives to improve efficiency and Quality in the preparation and execution of manufacturing processes. | - Makes recommendations on the basis of analysis and operational experience. | - Provides training or coaching to support changes/improvements or to address identified deficiencies in knowledge or capability
Global I&DT is responsible for driving the digital transformation for Fujifilm Diosynth Biotechnologies. We have some 100 employees spread over several IT departments globally. By 2030 Fujifilm Diosynth Biotechnologies will significantly have increased production capacity, and by using digitalization we aim to keep the operational costs down at the same time. You will be surrounded by a global pool of highly dedicated and skilled colleagues who all work on the mission of ensuring implementation of stable, efficient and compliant IT solutions supporting the company’s 2030 vision. | This position is in the Technical Project Management & Portfolio team. Currently the team has a team lead, two IT Project managers and one Portfolio manager, all located in Hillerod, Denmark. We are currently recruiting a new member of the team in the UK as well. In addition, we have several contractor IT PMs globally. | | This position is global, and you will be hired at our site in Billingham, UK. You will primarily work on local or global projects related to the Billingham site, but you may also be asked to run projects for other sites or global projects. Some limited travel may be required. | This role will not have any direct or indirect reports. | | Principal Accountabilities | • Run approved projects through the identification phase. This phase is important for us as this is where the solution, exact scope, the exact implementation and operational costs and resource needs are formally defined. Clear communication of the outcome is important. | • Plan and execute projects after the identification phase. Understand and manage the critical path. Managing risks and communicate effectively. | • Manage project resources – internal and external, and the project spend and budget. | • Report regularly to the project steering committee. | • Maintain strong relationship with the IT Project Owner | • Connect and proactively communicate with stakeholders both within and outside the projects. | • Use and help us improve our internal PM playbook. | • All other duties as assigned.
The Principal Infrastructure Engineer leads on the creation and maintenance of the IT/OT technical delivery roadmaps and provides input into the technical global strategy for the mission critical infrastructure. They with drive the operational cybersecurity capabilities and roadmaps globally across IT and ensure alignment with established standards such as NIST 800-82, ISA/IEC62443, CIS-20, and ISO27001. The role will be a infrastructure lead on the solution design and delivery on all FDB complex projects regarding technical and security task delivery on a global scale. The role will have a high degree of influence over BAU technology roadmaps, and you will be expected to navigate the organization across both IT & OT globally to ensure common ground and alignment. Because of the specialized nature of the role, it will be integral in not only enterprise technical delivery and solutions, but also in the project estimation/delivery/management, vendor selection, outsourcing activities, transitioning to operations, and in ongoing dialogues with our key stakeholder. Business and leadership you will be part of Global I&O team within the FDB IT Department, you will take a technical lead role together with other highly dedicated and skilled colleagues focused on the mission of ensuring a stable, efficient, and compliant IT services. This position will be lead role within the Infrastructure Engineer team with a focus on designing, building, deploying, and maintaining the FDB Global IT infrastructure while leveraging the latest technology. The role is responsible for ensuring that IT platforms are secure, reliable, backed up and always available. In addition, the role will also provide BAU technical governance on projects and solution design. The role is also responsible for the QoS regarding Infrastructure services and will provide 4th level Infrastructure support duties as required. | The Principal Infrastructure Engineer will work within the broader Digital Technologies organization to help drive IT/OT alignment regarding the provision of the infrastructure platform and services. In addition, the role is expected to have a broader reach outside traditional IT silos to build relationships within all IT service user towers. The role will interact up to senior-level stakeholders globally regarding technical requirements and delivery and any associated infrastructure needs both BAU and project wise. Will be required to interact with FDB vendors to ensure solutions are secure and always meet the business technical requirements. Technical Input in to external and internal audits about IT designs and services. | | Principal Accountabilities: | - Technical lead for the day-to-day support and availability of the FDB Global Infrastuture, this includes but is not limited to build, configure, administer, and support infrastructure technologies and solutions. These technologies and solutions can include computing, storage, networking, physical infrastructure, software, commercial-off-the-shelf software (COTS), and open-source packages and solutions. They can also include virtual and cloud computing such as Infrastructure as a Service (IaaS), Platform as a Service (PaaS) and Software as a Service (SaaS) | - Perform cross-functional, multidisciplinary technical oversight to include evaluation of project work, staff, methods, and associated procedures related to enterprise-level IT/OT systems. Ccompile technology related documentation for GxP and critical IT technologies. Participate in system validation and testing processes as required. Approve validation documentation together with relevant ITQ. Represent IT system in connection with audits and inspections | - Technical lead in defining and translating architectural designs into operational delivered solutions and services | - Responsible for leading the deployment of new technology, systems and hardware ensuring that they integrate smoothly with existing systems and infrastructure. They ensure that all FDB polices, and procedures are followed and that all deployed systems meet the security frameworks in place. They are responsible for ensuring AIS metrics are defined and met prior to new system/service deployment | Scope and Accountability: | - Responsible for establishing, owning and governance of the FDB global technical delivery and consolidation roadmaps that deliver against the IT/OT strategies that cover 1-5yrs | - Brief and advise senior IT management on technology constraints, issues, risks and produce solution documents and reports to support this | - Mentor peers and help build the IT/OT Opensource strategy within the organization on a global perspective, ensuring secure by design methodology | - Perform cross-functional, multidisciplinary technical deliveries to include evaluation of project work, staff, methods, and associated procedures related to enterprise-level IT/OT systems | - Aid senior IT management in establishing budget requirements in support of roadmaps and strategies for IT/OT technical and security initiatives | - Consult with system administrators, vendors, and other department personnel to provide guidance and technical support for proposed enterprise technical solutions ensuring alignment with overall business strategy and vision statements | - Technical lead for the cyber security design and governance of all IT/OT technical projects | The Principal Infrastructure engineer will work within the broader Digital Technologies organization to help drive IT/OT alignment from a technical and BAU perspective. In addition, the role is expected to have a broader reach outside traditional IT silos to build relationships. The role will interact with senior level stakeholders globally regarding technical delivery and any associated security requirements. Will be a technical lead on interacting with FDB vendors to ensure solutions are secure and always meet the business technical requirements. Input in to external and internal audits in regard to tactical designs and debt.
- Working with Electricity At Work Regulations | - Ensuring compliance with DSEAR (ATEX) | - Ensuring compliance with BS7671 | - Working on Site 11KV electrical system | - Working on Site 415V electrical system | - Working to Asset requirements | - Maintenance of switchgear | - Fixed wire testing | - Site compliance tasks | - Assist the Responsible Electrical Engineer with all tasks listed above and also project and facilities contractors on site
- Lead the administration of the Compliance Management process | - Lead the administration of the Management Review process | - Support the administration of Quality Management Systems | - Support/lead delivery of training in Quality Management Systems
- Delivery of Technology Transfer objectives and delivery through others technology transfer objectives | - Stewardship of the business processes and the standards required to deliver effectively technology transfer objectives. | - Sponsor, champion and manage delivery of capital projects | - Work with Asset Management Teams to provide appropriate standards for effective System Ownership to deliver best practice operating methods
- Interact with R&D and Engineering personnel as part of a programme team to support Technology Transfer of projects into the manufacturing facilities and to conduct plant and process troubleshooting during manufacture | - Execute Technology Transfer and manufacturing activities to achieve manufacture schedule targets | - The job holder will understand the requirements of GMP (e.g. Purpose of a BMR, role of a Witness, Good Documentation Practice) and ensure accurate data recording of executed tasks and activities in Quality documentation including but not limited to Batch Manufacturing Records, Logbooks and Qualification Protocols | - Ensure appropriate training status for all tasks and activities to be undertaken and ensure these tasks and activities are performed in a safe and compliant manner | - Identify and appropriately report all potential safety risks and violations | - Identify and appropriately report all deviations from defined operating procedures | - Demonstrate ownership of designated equipment and systems. | 8. Any other duties commensurate with grade
• Implementing, facilitating, and enforcing the FDB’s Trade Compliance policy. | • Support FDBK's trade compliance program and facilitating the proper and compliant importation and exportation of goods. | • Mitigate risks and costs associated with FDBK’s import/export operations. | • Manage trade compliance functions in accordance with the Import and Export regulations and other applicable trade regulations and FDB trade compliance policies and procedures. | • Identify and record applicable participating government agency requirements based upon product classifications.
- Fixed Assets: | Transactional postings for the monthly & quarterly fixed asset reporting & accounting under US GAAP and IFRS. | - Leases | - Oversight and responsibility for all aspects of Lease Accounting under relevant accounting standards (USGAAP and IFRS) including additions, initial recognition | - Capitalising engineering hours
| The Commercial Finance Business Partner is part of a global Finance function with a requirement at the UK Billingham site. This position is a key member of the Business Finance team within Global Operations Finance. This role requires a commercially minded and driven individual. | | - This is a ‘hands on’ role and will require a full understanding of the services offered by the business and the costs and profitability underlying our sales. It will require a good understanding of our competitors and the market in which we operate. | - Responsibility for the review and sign off of sales proposals, contracts, change orders, inter-co agreements and Master Services Agreement’s ensuring they follow the correct approval process for FDB. Also review for revenue recognition, profitability and cashflow implications, challenging clauses appropriately. This role will be the expert on financial clauses in contracts providing training and coaching as necessary. | - Partner the business in the construction and review of commercial supply agreements and major contracts with strategic customers ensuring all financial implications and risks are considered and challenged. | - Support Global Commercial Finance Partner in profitability modelling, providing peer review and backup. | - Partner with Central Finance/Corporate Accounting to ensure any non-standard contract terms adhere to group and local financial policies | - Proactively build and maintain effective relationships with the global commercial sales team, and programme management providing finance support and insight as required. Provide coaching and training linked to Finance. | - Responsible for reviewing customer credit ratings and making recommendations as appropriate. | - Drive improvements to the Customer Credit Review policy and process, including ongoing tracking and maintenance of data/information | - Drive improvements to the Customer Cancellation process, provide feedback loop to contract process and maintain necessary cancellation information required to support the policy. | - Responsible for dealing with internal and external audit queries and also provide audit evidence for contracts and revenue recognition as required. | - Support the Business Finance team, wider Operations Finance team, and local site Finance teams, contributing to financial modelling, cost models and price models.
The Key Account Manager EUROPE in the Global Alliance Management (GAM) team will support the SVP, Large Scale commercial in development, maintenance and execution of strategies to strengthen existing relationships and foster new relationships with key accounts to support the continued growth of FDB across Europe and US. | | As a Key Account Manager, you are responsible for a number of key accounts and driving the strategy and execution of the relationship development and sales for that account. | | - Work with SVP, Large Scale Commercial as well as other key stakeholders to develop and implement strategies to support the growth of FDB aligned with the near term, mid-term and long term plans on Key accounts. | - Develop and nurture deep relationships with your key account(s) to increase the probability of FDB being selected as the preferred supplier of outsourced work that fits within the current FDB service portfolio. | - Leverage relationships with Key account(s) to identify trends and needs and provide feedback to the FDB Strategic Business Development group to support continued investment and business diversification. | - Work with broader commercial team and Program Management teams on relationships impacted by key accounts. | - Negotiation/re-negotiation commercial contracts with accounts including MSA’s, CSA’s, Scopes (as appropriate), equipment/capital purchases, etc. | - Establish and maintain horizontal and vertical relationship with other Key Account teams and stakeholders including C-suite, procurement, decision makers and influencers. | Any other duties commensurate with the role. | |
The VP Commercial Development Biologics will support the SVP, Commercial in the development, maintenance, and execution of strategies to strengthen existing relationships and foster new relationships through the leadership and management of the Biologics team, which will support the continued growth of FDB and ensure we meet our strategic goals and ambitions. The VP Biologics will lead and support the Biologics Commercial Development teams for all FDB CDMO services. | | Duties and Responsibilities include the following. Other duties may be assigned. | | - Work with the SVP, Commercial and the Commercial Leadership Team to design and implement strategies to support the growth of FDB aligned with the near-, mid- and long-term plans. | - Provide effective leadership and management of the Biologics team to ensure they develop and nurture deep relationships with customers to identify trends and needs of the market and provide feedback to the wider FDB team to support continued investment and business diversification. | - Management of accounts which require senior support. | - Coach and mentor the Executive Directors, Biologics to ensure they excel in their roles and therefore provide great customer service to all key accounts. | - Work with the broader FDB teams to ensure effective support to the Biologics team. | - Support with recruitment, on-boarding, succession planning and career development of the team. | - Act as a point of escalation for customer complaints/concerns. | - Negotiate and re-negotiate commercial contracts with accounts including MSAs, CSAs, Scope of work, equipment, and capital purchases. | - Be accountable for team pipeline development, management, and reporting. Provide leadership to teams to ensure that account plans and strategies are targeted and aligned with commercial targets | - Lead major site customer visits and ensure we have effective cover for all key accounts across the network. | - Ensure cross functional collaborative and project team leadership assignment consistent with personal strategic, operational, and technical leadership. | - Attend commercial events to promote the work of FDB and support lead generation.