Senior Scientist (External Stability)
91 Park Drive, Milton Park, Oxfordshire, OX14 4RY, UK
MAIN PURPOSE OF JOB
To plan, initiate, track performance and report on stability studies performed at External CDMO’S supporting the advancement of the company product pipeline with adherence to the required quality systems. To conduct and design experimental investigations to support a low dose parenteral bio-pharmaceutical in the development and management of integrated stability strategies supporting Immunocore’s bio-pharmaceutical platforms. Manage and perform Quality Control analytical testing for stability studies, compliant with GMP and Immunocore QMS, supporting coordination of all aspects of the studies and with accountability for driving related quality investigations to timely closure.
Role will cover supporting trouble shooting, OOS, OOT episodes as well as writing QE’s quality documents and operating procedures for the team as well as reviewing and approving internal and external documents.
Interaction with external CDMO’s as well as internal stakeholders such as CMC, regs and clinical is a large component of the role.
Supporting other members of the stability team as well as the formulation team with documentation and possible wet work when resources are limited.
- Management of External stability studies at CDMO’s. Planning, co-ordination, and day-to-day performance of external stability studies
- Champion and pro-actively evolve the GMP and Quality driven processes for ensuring data integrity of results being generated and reported from the Quality Control functional area
- Operate in compliance to the defined Immunocore Quality management Systems
- Manage the compilation of QC testing metrics to drive method and quality improvements
- Identify and report method remediation requirements cross-functionally to analytical subject matter experts
- Competent to perform and train Quality Control team members in the portfolio of analytical stability test methods
- Perform Stability Testing for Development studies, or other related test method performance within Quality requirements, across Immunocore projects
- Execute test methods in accordance and compliance with documented SOPs
- Document testing in compliance with local procedures, forms and templates
- Conduct technical and Quality reviews of testing records
- Own and support team members in documenting unexpected result, invalid test, and non-conformance investigations
- Ensure data integrity of reportable results, including data transcription across documents
- Perform trending and statistical analysis
- Compile reports
- Write and update SOPs, ensuring they are fit for purpose with appropriate detail and content
- Train analysts in stability test methods and Quality expectations
- Prioritise activities and manage the timely delivery of Quality approved stability results
- Ensure all work and documentation is performed to a consistently high level of accuracy and compliance
- Oversight of control for sample management for stability studies within related quality systems
- Responsibility for controlled stability sample storage, and the suitability and maintenance of equipment used in stability studies
- Support planning, design and content of stability studies
- Stay up to date with ICH and relevant regulatory guidelines
- Write and Review stability protocols
- Input to compilation of regulatory documents
- Support management, oversight and evaluation of externally run stability studies
- Operate in accordance with the Company’s Health and Safety policies, especially within a laboratory environment.
- Manage external CDMO stability interactions
- Quality Function and Compliance: Consistently and enthusiastically endorse established Quality Control functional systems, communicating and sharing experience and knowledge within the team to ensure data integrity of the reported results. Manage and be accountable for driving quality investigations to ensure appropriate content and their timely closure. Pro-actively assess and evaluate GMP Quality Control systems, procedures and performance metrics to drive and lead continuous improvement opportunities through open team communication and collaboration
- Quality Testing and Data Analyses: Manages and performs stability testing, in accordance with GMP and company quality systems, ensuring data integrity of the results output for inclusion in regulatory documents. Perform Trending and Analyses of standards and controls to monitor method performance, as well as trending of stability results to further justify product shelf-life claims.
- Metrics and continuous improvement: Identifies and compiles key performance indicators for reporting GMP Quality metrics and driving continuous system improvements. Also using technical knowledge of key stability indicating assays for identifying method remediation requirements / opportunities and reporting these for evaluation by the analytical development subject matter experts.
- Stability / Technical Knowledge: sharing knowledge and experience with the wider team and, across departments representing the stability team both internally and externally. May also act as a mentor or manager to other colleagues, especially new hires, sharing scientific and company knowledge. Keeping up to date with regulatory guidelines relevant to the role and/or advancement in product stability requirements for studies on Biologics; sharing these with leaders across the Company.
- Test Records and Documentation: ensuring that all stability test records and related QMS documents are accurate, completed in a timely fashion, and to required quality standards, supporting their use in company regulatory submissions. Support and encourage others to achieve and maintain the required high standard of documentation, testing performance and data integrity.
- Outsourced projects and studies: Support management , oversight and evaluation of externally run stability studies, providing input on aspects including quality, trending and raw data in relation to presenting results in regulatory submissions
- 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.
- Communication: communication and presentation of findings and conclusions from stability studies supporting all company products in meetings with colleagues, senior management and partners.
- Training: ensure training is received, up to date and documented to support role. Perform and support training for others, as appropriate. Train and perform analytical testing to support stability studies, if required.
- Health & Safety: championing and helping others to understand H&S within the company, providing ad-hoc training as required
EXPERIENCE AND KNOWLEDGE
- Proven experience (2-5 years) of analytical method Quality Control testing and working to GMP compliance
- Extensive knowledge of stability study coordinator tasks, including study design, testing requirements, quality checking, setting acceptance criteria and method performance controls, managing investigations and writing reports
- Sound understanding of stability and related ICH / other regulatory guidelines
- Performing methods in compliance with SOPs
- Understanding of system suitability criteria and assay acceptance criteria for assessing test validity
- Familiar with established documentation practices for stability programs
- Experienced in writing study documents, including protocols & reports.
- Performing stability trending and analysis
- Working to QMS procedures and documenting Quality events (e.g. OOS, NCs)
- Pro-actively contributed to maintaining and enhancing GMP and quality working practices (both laboratory and office environments)
- Familiar with requirements for ensuring data integrity of reported results
- Recorded results in a concise and timely way, and in compliance with agreed standards
- Understanding of analytical requirements to support clinical and commercial products
- Worked and contributed actively in a diverse team environment
- Excellent organizational and communication (verbal and written) skills
- Knowledge of bioassays, biopharmaceutical assays, statistical evaluation of assay variability
- Experience with sample management
- Understanding of analytical requirements to support clinical and commercial products
- Knowledge of method validation requirements to demonstrate stability indicating capabilities
- Experience of forced degradation studies and Analytical characterisation supportive of demonstrating product stability
- Knowledge of formulation development of Bio-pharmaceuticals
- Proposed and driven changes in working practices that have improved efficiency, supported teams through adoption and change
- Mentored and coached less experienced colleagues in scientific and stability related projects
- Presented at external meetings
KEY BEHAVIOURAL ATTRIBUTES
- 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.
EDUCATION & QUALIFICATIONS
- Essential: BSc. Or MSc. in protein engineering, biochemistry, molecular biology or related discipline
- Desirable: PhD in related discipline