Principal Formulation Development Scientist

Full details of the job.

Vacancy Name

Vacancy Name Principal Formulation Development Scientist I

Vacancy No

Vacancy No VN705

Employment Type

Employment Type

Permanent

Location of role

Location of role Oxford, UK

Department

Department CMC

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 bio pharmaceutical in the development and management of integrated formulation strategies supporting Immunocore's bio pharmaceutical platforms. The formulation role will be a hands on role, primarily focussed 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 biologicals. 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.

• 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 that 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. Specifically:
    • Develop drug delivery approaches for the biologics portfolio.
    • Bring in new technologies exploring new administration approaches.
    • To 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 of routine assays.
    • Writing of SOPs.
    • Contributing to regulatory documentation.
    • Participation 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.
    • Hand 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…