Overview
Senior Process Development Scientist, Upstream – Oxford
Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. 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. 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.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
To conduct and design experimental investigations for upstream process development of emerging drug candidates, supportive reagents and enable successful establishment of upstream processes for manufacturing and clinical development. Mammalian cell culture is core to this role, requiring experience and knowledge, particularly with CHO cells, in transfection, transient and stable expression, shake flask and bioreactor culture, feeding strategies and growth and quality assessments, including titer measurements. Microbial cell culture experience is also required, in shake-flask and bioreactors. Technical oversight to ensure regulatory compliance and support of external upstream manufacturing at GMP is also key to this role, including review of batch records, Person-in-Plant, interaction with CDMOs and supporting development or troubleshooting the upstream manufacturing process. The ability to work independently, as well as part of a team and to tight deadlines, is essential. Robust record-keeping, writing and review of regulatory documents (IND/IMPD) and strong communication skills are also required.
KEY RESPONSIBILITIES – ALL SCIENTISTS
* Conducting experiments, observing, interpreting, and responding to results.
* Designing experimental protocols and writing reports
* Planning experiments and carrying out priorities, with guidance from line manager
* Maintaining and increasing technical knowledge in relevant fields through self-study, observation and attending relevant conferences or training courses.
* Maintaining accurate records of all work by completing laboratory notebook on time, following company procedures.
* Ensuring laboratory equipment is operated in accordance with safety and risk guidelines, acting promptly to report any faults or problems to the relevant member of staff.
* Operating in accordance with the Company’s Health and Safety policies, especially within a laboratory environment.
SPECIFIC RESPONSIBILITIES
* Experiments: independently testing and, increasingly, leading lines of investigation. Proposing new experiments based on emerging data and other related information. Providing support on technical aspects to others. Conduct and design experiments to support manufacturing at GMP; to support pre-clinical, clinical, and analytical assays, and regulatory submissions. Writing and following experimental protocols. Writing and reviewing reports.
* Priorities: establishing priorities for own work and team-based projects; making decisions on prioritisation, with support from line manager, based on the overall goals of the team, department, and project, using direct evidence and personal experience as guidance.
* Technical knowledge: sharing knowledge with the wider team and, across departments representing the department both internally and externally. May also act as a mentor or manager to other colleagues, especially new hires, sharing scientific and company knowledge. Increasingly providing analysis of new techniques and theories from outside the Company to advance the way the company works; sharing these with leaders across the Company. Provide technical guidance to others within the team on how to use equipment most effectively; making recommendations regarding acquisition of new pieces of equipment.
* Laboratory records: ensuring that all records and information are up to date, on time and recorded to the correct standard. Supporting and encouraging others to achieve this.
* Laboratory equipment: providing technical guidance to others within the team on how to use equipment most effectively; making recommendations regarding acquisition of new pieces of equipment.
* Reporting: communicating and presenting findings at meetings with colleagues, senior management, and partners. Regular reporting on progress of work verbally and in writing. Protocols and reports to be written and reviewed to meet the Immunocore Quality system.
* Health & Safety: championing and helping others to understand H&S within the company, providing ad-hoc training as required.
PERSON SPECIFICATION
EXPERIENCE AND KNOWLEDGE
Essential
* Worked in a bench-based mammalian process development, biochemistry, l or bio-pharmaceutical laboratory environment with a recognized and established expertise to:
– Execute and optimise mammalian expression in bioreactors
– Aid the upstream production of biologics to support downstream processes, analytical characterisation and formulation studies
– Show a strong analytical mind with the ability to interpret complex datasets and propose sound experimental strategies
– Have an awareness of cGMP and biopharmaceutical manufacturing requirements
* Strong practical knowledge of mammalian cell culture for lab scale expression and scale-up requirements for biopharmaceuticals.
* Microbial expression of recombinant proteins in shake-flasks and bioreactors
* Proposed and driven changes in working practices that have improved efficiency, supported teams through adoption and change
* Driven the direction and progress of work to aid attainment of deadlines or results
* Communicate effectively to summarise complex data / findings to wider functional project teams
* Record results in a concise and timely way, and in compliance with agreed standards
* Mentored and coached less experienced colleagues in scientific practices and theory
* Able to interpret results with minimal guidance
* Increase technical knowledge and keep up to date with new technologies to enhance the capabilities of the team
* Ability to network between teams and disciplines
Desirable
* Molecular biology skills
* A good understanding of ICH cell bank characterisation requirements and test methods
* Familiar with process scale up activities aimed at achieving complete process understanding and control, as well as building robustness into biologics production platforms using DoE implementing QbD and use of scaled-down systems, such as Ambr.
* Experience with analytical methods such as SDS-PAGE, Octet and HPLC
* Liaise with the USP, DSP and the Analytical teams to ensure the smooth transition of projects through development and the successful transfer of optimised processes to manufacturing.
* Carry out technology transfer of biologic production processes to Contract Development Manufacturing Organizations including preparation of study reports and technology transfer documents, as well as troubleshooting process transfer issues. Technical oversight of upstream manufacturing activities at CDMO and Person-in-Plant, as required.
* Mentorship or technical guidance (formal or informal) of technician/scientists in upstream process development techniques or project management of a technical area
* Regulatory CMC document writing contributions (IND, IMPD)
* Current knowledge pertaining to drug development of biotherapeutics
* Contributing to external scientific collaboration
EDUCATION & QUALIFICATIONS
* Essential: BSc. or MSc. in protein or biochemical engineering, biochemistry, microbiology, molecular biology, or related discipline
* Desirable: PhD in related discipline
* Desirable: Relevant industrial or post-doctoral academic experience
