Principal Formulation Development Scientist I

IMMUNOCORE LTD; Oxford; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading biotechnology company seeks a technical leader in formulation development in Oxford. You will conduct experiments, lead lines of investigation, and develop innovative strategies for biologics. The ideal candidate has a PhD and over 8 years of relevant industry experience, particularly in drug delivery and formulation studies. This role involves collaboration with clinical, regulatory, and CMC teams to support regulatory filings and advancement of biopharmaceutical products in an innovative environment.

Qualifications

• Proven industry experience in formulation strategies for biologics.
• Strong background in design of formulation studies and biochemical techniques.
• Experience with process development for production of biologics.

Responsibilities

• Conduct experiments and interpret results for formulation strategies.
• Direct investigations into drug delivery approaches for biologics.
• Develop and design formulations for drug products.

Skills

Recombinant protein formulation

Analytical development

Drug delivery

Chromatographic assays

Electrophoretic techniques

Education

PhD in bio-manufacturing, protein engineering, biochemistry or related discipline

Job description

The primary purpose of this role is to serve as a recognized technical leader in formulation development, leveraging extensive experience and expert knowledge to drive innovation and contribute to the company's scientific strategy. The incumbent is expected to advocate for process, platform, and technology improvements, and apply advanced knowledge of scientific principles and the drug development process to solve extremely complex problems. The individual will exercise independent judgment in developing methods and techniques, consistently making the right calls to achieve results. This position will be responsible for conducting and designing experimental investigations to support a low & high dose parenteral biopharmaceutical in the development and management of integrated formulation strategies supporting Immunocore's biopharmaceutical platforms. The formulation role will be a hands‑on role, primarily focused on lab work designing and performing experimental work. It will also cover drug delivery approaches, investigate novel technologies such as LNP, Pegylation and other delivery systems applicable to biologics. The role will also cover early stressing studies, formulation excipient screening, CMC process support, drug substance and drug product through to compatibility with final patient delivery systems. Support and direct IUS studies and progress the clinical programmes. Support and respond to main stakeholders – for example Clinical and Regulatory teams – in the delivery of the clinical strategies. To work in close collaboration with the Head of Formulation, CMC teams and related functions to input into the formulation‑related sections for regulatory filings, development reports and other development‑related documents. Advanced people‑management skills are essential, including managing changing priorities while maintaining team motivation. They will create a safe environment for learning from mistakes, establish clear career paths, and hold career‑development conversations. The individual will engage in difficult conversations where appropriate, inspire action, and show employees how they contribute to higher goals.

Key Responsibilities

• Conducting experiments, observing, interpreting and responding to results.
• Maintaining and increasing technical knowledge in relevant fields through self‑study, observation, attending relevant conferences and training courses.
• Maintaining accurate records of all work by completing laboratory notebooks 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.
  • Develop drug delivery approaches for the biologics portfolio.
  • Bring in new technologies exploring new administration approaches.
  • Conduct and design experiments to establish formulations for TCR platform API and IMP.
  • Lead and direct pre‑formulation, cycle 1, 2 and 3 activities.
  • Conduct drug presentation studies to evaluate alternative drug administration routes (e.g., sub‑cut).
  • Represent formulation in CMC teams.
  • Investigate compatibility of drug product through delivery devices for patient administration.
  • Investigations in novel drug delivery formats.
  • Perform testing and develop test methods to support stability and formulation studies.
  • Carry out and optimise production of recombinant protein supportive reagents, including conjugations.
  • Communicate key findings to managers and scientists in other groups.
  • Review/sign‑off routine assays.
  • Write SOPs.
  • Contribute to regulatory documentation.
  • Participate in laboratory maintenance.
  • Perform IUS studies.
  • Perform clinical compatibility studies.
  • Direct investigations into IUS clinical site excursion event impacts.
  • Identify new external scientific technology and collaborations.
  • Introduce new science into the group.
  • Hands‑on practical role.
• Priorities: establishing priorities for own work and team‑based projects; making decisions on prioritisation 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.
• 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.
• Health & Safety: championing and helping others to understand H&S within the Company, providing ad‑hoc training as required.
• Reporting: communicating and presenting research findings at meetings with colleagues, senior management and partners.

Qualifications

• Background in recombinant protein or antibody formulation, drug delivery of biologics, analytical development or protein characterisation, with proven industry experience and exposure to formulation strategies.
• Experience in design of formulation studies, including the utilisation of Design of Experiments principles.
• Strong expertise in electrophoretic or chromatographic assays and general biochemical lab techniques.

Desirable

• Experience of process development for production of biologics and conjugation of biomolecules.
• Experience with lyophilisation development of biotherapeutics.
• Familiarity with biopharmaceutical stability study principles.
• Familiarity with novel drug delivery formats.
• Proactive in ensuring high quality of work and seeking additional responsibilities to help meet the goals of the team.
• Presented detailed scientific findings and papers to internal and external audiences.
• Essential: PhD in bio‑manufacturing, protein engineering, biochemistry, molecular biology or related discipline.
• Industrial company experience delivering formulations through drug development phases.
• Normally requires a PhD in a scientific discipline and a minimum of 8+ years related experience; may include post‑doctoral experience.

Immunocore (NASDAQ: IMCR) is a pioneering, commercial‑stage T cell receptor biotechnology company whose purpose is to develop and commercialise 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 recognise 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.