MAIN PURPOSE OF JOB
Drive and implement formulation strategies to deliver the pipeline. Input into new approaches in formulation design, lead and direct enterprise wide formulation initiatives. To conduct and design experimental investigations to support a low dose parenteral bio-pharmaceutical in the development and management of integrated formulation approaches supporting Immunocore’s bio-pharmaceutical platforms. The formulation role will 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 stake holders for example Clinical and Regulatory teams in the delivery of the clinical strategies.
To work in close collaboration with other members of Formulation, CMC teams and related functions to input into the formulation related sections for regulatory filings, development reports and other development related documents.
KEY RESPONSIBILITIES – ALL SCIENTISTS
- 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.
- Scientific and technical leadership : Identify, implement and startegise formulation principles to drive business efficiency within the group and organisation
- Enhance the formulation teams external visibility by presenting at external meeting and sitting on external advisory bodies
- Internalise new capabilities through awareness and providing business justifications for cpabaility build within the team
- Identify and lead best practices to elevate formulation practices within the industry
- Management of resources
- Manage a core group of scientist to deliver business objectives
- Define and apply resource management skills to deliver competing priorities
- Mentor junior scientist to enhance formulation principles
- 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:
- 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
- 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.
- Manage/Direct IUS studies.
- Manage and Direct clinical compatibility studies.
- Manage/Direct investigations into IUS clinical site excursion event impacts.
- Strategize IUS study programmes/scheduling/development.
- Identify new external scientific technology and collaborations.
- Introduce new science into the group.
- Manage external collaboration with academic institutions
- 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..
- May also act as a mentor or manager to other colleagues, especially new hires
EXPERIENCE AND KNOWLEDGE
- Background in recombinant protein or antibody formulation, 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.
- Experience of process development for production of biologics and conjugation of biomolecules
- Experience with lyophilisation development of Biotherapeutics
- Familiar with biopharmaceutical stability study principles
- Familiarity with novel drug delivery formats
- proactive in ensuring high quality of their work and seeking additional responsibilities to help meeting the goals of the team
- Presented detailed scientific findings and papers to internal and external audiences
KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF
- Openness and honesty
Readily offering information pertaining to work in hand whether positive or negative.
- Taking responsibility
Being prepared to accept full responsibility for tasks entrusted to them; seeing tasks through to completion and dealing with the consequences of failure or success.
Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities. Handling disjointed tasks effectively.
- Team spirit
Being able to work productively with others to achieve tasks. Showing consideration for the needs and feelings of others.
SPECIFIC BEHAVIOURAL ATTRIBUTES
· Analytical Thinking - Tackling problems by using a logical and sequential approaches, making systematic comparisons of two or more alternatives.
· Attention to Communication - Writing and speaking clearly to share thoughts and information ideas concisely and ensuring information is passed on effectively.
· Diagnostic Information Gathering - Seeking perspectives, information and clarification on problems from others, checking multiple sources for complete and accurate information.
· Managing Self Performance - Agreeing specific, measurable and realistic but challenging goals.
· Results Orientated - Focusing on desired results, overcoming obstacles and sometimes frustration, with an urgency to get things done.
· Teamwork - Working cooperatively as part of a team, actively listening and constructively responding to others ideas.
· Thoroughness - Ensuring own and others work and information is complete and accurate.
· Written and oral communication - Writing and speaking clearly to share thoughts and information concisely and appropriately.
· Building collaborative relationships - Developing, maintaining and strengthening partnerships with others who can provide information, assistance and support.
· Fostering teamwork - Working cooperatively with others listening, responding and offering support for ideas and proposals, whilst constructively expressing differing views.
· Influencing others - Gaining support from others support for ideas, proposals projects and solutions, knowing when to escalate critical issues.
· Initiative - Proactively identifying what needs to be done. Undertaking more than what might be normally required and seeking opinions of others.
· Interpersonal awareness - Understanding, interpreting and anticipating the concerns and feelings of others, noticing the use of language, tone of voice and behaviour.
· Conceptual thinking - Adopting a holistic, abstract or theoretical perspective in order to notice similarities between different and apparently unrelated situations.
· Developing others - Coaching and supporting others to develop their capabilities, providing appropriate and specific feedback.
· Forward thinking - Anticipating the implications and consequences of situations, taking appropriate action in order to be prepared for possible contingencies and planning accordingly.
· Fostering innovation - Developing, proposing and supporting new approaches, methods and technologies that improve effectiveness, working cooperatively with others to produce and implement these innovative solutions.
· Managing change - Supporting, implementing and initiating innovation and organizational changes to improve effectiveness, helping others to successfully manage these changes.
· Providing motivational support - Encouraging others, sharing ideas in a way that energizes groups, acknowledging people for their contributions and promptly tackling any problems impacting morale
(Please see the intranet for further information on behaviours, those in Italic are new to this role/ different to the previous level)
EDUCATION & QUALIFICATIONS
- Essential: MSc or PhD. In bio-manufacturing, protein engineering, biochemistry, molecular biology or related discipline
- Proven knowledge of formulation development in industrial setting