IMMUNOCORE is looking for employees for positions:
manufacturing manager
Responsibility
our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers
we are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions
focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform
project Management of DP validation project to deliver Clinical and ultimately commercial DP to support Immunocore's Clinical and commercial demand
execute strategic sourcing activities to enable expansion of Immunocore's supply base
interface with selected CDMOs to ensure all aspects of project are managed and executed to plan
you will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies
report Programme Performance into monthly CMC meetings
Requirements
educated to BSc level or equivalent Appropriate Work experience in Biopharmaceuticals Manufacturing
essential
previous experience in CDMO supplier selection and qualification
experience in Contract Negotiation and execution
prince 2 Or other project management qualification
experience in coordinating Validation activities at DP level and preferably DS, taking clinical to commercial
proven experience in on-time Execution of Transfer programmes
experience in GMP Operations
facilities manager
Working hours
full-time
Responsibility
our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers
we are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions
focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform
you will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies
support the Facilities Engineering Co-ordinator on the utilisation of the site BMS system, engaging with the Supplier around improvements and issues
be the day-to-day point of contact on site, for all FM matters, escalating to the Facilities Director when appropriate
take the lead on, and ensure compliance that, all PPM tasks are completed and up to date inline with SFG20 maintenance regime. That all associated building maintenance tasks, including remedial works are carried out to an acceptable standard
actively participate into ongoing development of the company CAFM system including updating and reviewing
Requirements
gasSafe
F-Gas
cert of competence CPA1
essential
permit to Work systems
demonstrable knowledge and experience in meeting statutory requirements across an array of buildings
knowledge of BMS & CAFM or AMICI
proven knowledge in problem solving, in relation to mechanical equipment and general PPM/FM
supply chain manager
Working hours
full-time
Responsibility
our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers
we are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions
focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform
ensuring the logistical, compliance and regulatory integrity of Supply Chain activities to enable progression of Commercial activities
you will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies
our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases
we strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients
we aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity
Requirements
essential
minimum of 3 - 5 years of progressive Supply Chain management and experience within pharmaceutical industry
breadth of Supply Chain management experience, including supply planning and procurement
experience working with Contract Manufacturing/External Supply Management
experience with commercial pharmaceutical/biotech company supply chains preferred
strong background of working with ERP/MRP/Supply Chain systems and tools
essential: BSc. or MSc. in business, supply chain operations or related discipline
excellent supply chain analysis skills
project manager
Responsibility
responsible for the successful execution and oversight of assigned programs ensuring the deliverables are met with quality, timelines and budget
lead RPF processes from proposal development through to vendor selection and contract negotiation
review, negotiate and approve any required change orders
management of the overall study budget, ensuring the budget stays within forecast and the approved budget
routinely review study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies
provide oversight and accountability of all third party vendors assigned to a programme. Being a point of contact, making sure programmes run in accordance with GcP and IHC
this includes reviewing primary and secondary efficacy and safety endpoints for inconsistency, irregularities, and/or signals
ensuring programmes meet all GCP/ICH guidelines and are inspection ready
Requirements
essential
vendor oversight experience
presented high level presentations, both orally and in writing, using organizational skills to complement this
ensured an enthusiastic and open attitude towards continuous professional development
BA / BS. or higher in science related field
desirable
proven ability to manage multiple protocols
fully understood and applied the principles of GCP. Creating and maintaining healthy and creative relationships with study sites and principle investigators, helping to support and influence where required
software developer
Responsibility
development and maintenance of production-quality modules for the Immunocore database system
development and maintenance of key analysis pipelines
liaising with key leaders from the scientific teams to gather and refine software requirements
committed to developing a conceptual understanding of scientific workflows
able to offer technical solutions to bottle necks in data and workflow management
responsibility for own software development projects and meeting delivery goals
performing code reviews
assist with maintenance and development of bioinformatics analysis pipelines
Requirements
essential
demonstrated proficiency in Python/Django and/or JavaScript/React/HTML/CSS
demonstrated understanding of relational databases and experience of SQL
professional experience in the development of web-based applications
excellent communication skills
understand concepts and propose new solutions
possess solid theoretical background of software development practices and technologies
degree with significant relevant role experience
senior project manager
Responsibility
ensure successful execution and oversight of assigned programs ensuring the program deliverables and milestones are met with quality and within budget
provide oversight and accountability of all third-party vendors assigned to a program or assigned protocol
accountable for ensuring all study deliverables and milestones are met with quality and within timelines
review, negotiate and approve any required change orders
provide support/escalation point for direct reports as needed
ensure program meets all GCP/ICH Guidelines and is Inspection Ready
manage supportive Clinical Operations function , by providing oversight and guidance of their task execution as required to ensure regulatory compliance of protocol activities, if appropriate
play an active part in CRO selection and review of RFP's when required, ensuring the appropriate CRO is identified and properly vetted
Requirements
essential
experience with Vendor oversight
experience with all aspects of the conduct of a clinical study including start-up through close out
create and maintain healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required
ability to communicate and coordinate activities with the internal team, clinical sites and vendors
fully understand and apply the principles of effective clinical project practices, achieving agreed outcomes
ability to work independently
present high-level presentations, both orally and in writing using organizational skills to complement this
Education
BA / BS. or higher in science related field
experience must include global/international studies or programs
experience in infectious disease and/or oncology is highly desired
at least 5 years relevant experience in a biotechnology/pharmaceutical industry and/or clinical research organization, including majority of time in clinical study/project management
demonstrated computer skills; proven functional knowledge of Microsoft packages and ability to develop proficiency in relevant Immunocore IRT and EDC systems and programs
senior technician
Responsibility
extensive cell culture of multiple cancer cell lines and preparation of good quality cell pellets for further analysis
cell transfection and preparation of FFPE cell pellets
tissue processing
general lab maintenance
collaborate cross-functionally to help validation of our targets
report experimental results in writing
Requirements
essential: extensive technical experience in cell culture and cell manipulation
desirable: experience within a drug discovery industrial environment
compliance manager
Responsibility
regulatory Compliance Activities
oversee the monitoring and periodic review of systems to ensure continuous compliance
conduct necessary IT compliance control monitoring and testing activities to determine the effectiveness of the controls
remediate IT compliance control deficiencies
actively support upkeep and maintenance IT compliance policies, based on any relevant regulatory changes or new laws
accountable for Computer Systems Validation process and documentation to ensure compliance with regulatory frameworks throughout the IT asset lifecycle for regulated systems
GDPR and Privacy Activities
support Immunocore's GDPR requirements for DPIA, SARs, Breaches and Article 30
Requirements
essential
minimum 5 years' experience working in the life sciences / pharmaceutical industry
direct experience with Health authority audits against IT controls in the life sciences / pharmaceutical industry
demonstrable experience in development of processes and procedures
must possess the ability to make quick decisions needed to thrive in a challenging and fast-paced environment
demonstrably effective at handling multiple simultaneous tasks, with associated & changing deadlines
must be able to communicate clearly and effectively to achieve desired outcomes
demonstrable ability to build trusted working relationships with colleagues and stakeholders across various organizational functions
Education
undergraduate degree in computer science, business administration; graduate degree in one these fields or strong employment-based experience
industry-related compliance, information security or business continuity management certification or previous employment-based experience preferred
lifesciences quality related certification/qualification from ISPE, ASQ or other
exposure to or awareness of quality management process such as ISO9001 and ISO27001
systems and or auditing related certifications or qualifications such as IAA or ISACA
senior finance business partner
Responsibility
deliver timely and accurate financial information, insights and reporting to enable assigned business area to make well-informed business decisions
act as primary point of finance contact for the functions, providing hands-on support to these functions as necessary
calculate and lead monthly accrual process with CMC and HR and CMOs, comply with SOX
drive regular meetings with CMOs to review each program
provide advice, support and challenge to support improved cost controls, compliance with internal controls and efficient resource allocation
actively engage, partner with and update key stakeholders
drive delivery of targets by supporting and challenging stakeholders through development and production of relevant metrics
provide financial modelling, budget appraisal and support to develop robust business cases which align to strategy and consider benefits and risk
Requirements
essential
experience of collaborating with cross-functional colleagues on financial matters and projects
CRO or Clinical trial finance management experience in Pharma/Biotech
experience of using ERP/Accounting Systems
proven track record of process improvement
desirable
industry experience within a high-tech, fast growing organisation
experience of using NetSuite software
engineer
Responsibility
develop and maintain bioinformatic pipelines for processing and analysing genomics, transcriptomics, and proteomics data
design and implement algorithms for biological data analysis
liaise with bioinformaticians and wider scientific teams to understand project requirements and translate them into technical solutions
critically identify flaws in the current system and propose solutions. Optimise existing algorithms and software tools for performance, scalability, and accuracy
contribute to development and maintenance of custom software applications, databases and production-quality modules for the Immunocore pipeline database system
stay current with advances in bioinformatics and data science and integrate new methodologies into our workflows
collaborate with cross-functional teams to integrate bioinformatic solutions into broader research projects and workflows
document and test code, algorithms and workflows. Provide training and supporting guides as required