Spherical Search have recently partnered up with a well-known analytical testing/CRO company in the field of inhalation drug delivery who are working with device developers and pharmaceutical companies to develop innovative and safe products. We are looking for a Specialist (Formulation) to join the team. ROLE OVERVIEW AND RESPONSIBILITIES To operate as a Scientific and Technical Expert in your specific speciality. This speciality will be in focused and dedicated field recognised in the industry To support the Pharmaceutical Development Units (PDUs) in the capacity of using your specialism, to allow delivery of the revenue-generating portfolio of work for our customers, internally and externally, efficiently, and effectively. This may include: Provides technical experience and support to development teams. Expected to be a hands-on role where scientist provides practical application of specialist skill e.g. use of specialised instruments Senior user and responsible person for specialist equipment and laboratory areas, in conjunction with the Operations team Learning, teaching, and training of team members. Reviewing reports for technical and scientific accuracy with regards to data analysis or conclusions (but not as a routine reviewer). Involved in customer/stakeholder/sponsor discussions and presentations to ensure the most significant capabilities are made available to these interfaces. The resolution of technical challenges faced by the scientific teams. To support our customers, academic/regulatory agency collaborations with product development programs leveraging the full range of tools and resources. This may include: Participating in calls, workshops, problem solving, technical discussions and project review processes/meetings as required, to leverage your experience and technical capabilities. Lead dynamic metric-based teams to solve critical problems, move technology/capability forward or as part of internal programs. Develop the relevant SOPs, tools, processes, and associated methodologies (if required) for the use by the Pharmaceutical Development Units (PDUs), for use in revenue and internal projects. To support novel research and development in the field of aerosol-based delivery technologies and associated disease state treatments, including the development of new inventions and intellectual property primarily in the fields of formulation of aerosol based pharmaceutical technologies. Support the monitoring of the critical equipment within your specialist area for effectiveness and operability/efficiency. o Support the comprehensive Preventative maintenance and Reactive Maintenance as required. To enhance the capabilities and reputation of the company continuously. Present at conferences and publish in peer-reviewed journals. Act as a role model for the organisation as a scientific leader in the organisation. Act as the technical exert the specialist field, supporting customers, team members, academic/industrial partners, regulatory agencies, Senior Management, R&D and Business Development in this area. Assess the applicability and limitations of new technologies within specialist field and make recommendations for use in the company Identifies potential efficiency gains in core area of expertise that facilitate project and product delivery. Build and maintain awareness of external experts and relevant technology suppliers in specialist field Responsible for the management and leadership of specialist area methods, processes and associated tools/techniques JOB DETAILS / RESPONSIBILITIES Job descriptions cover approximately 85% of a role, and are not an exhaustive list of responsibilities and duties. You are expected to carry out other activities that are within reasonable scope of the role. BASICS Promote company’s best interests at all times by the positive and effective manner in which you perform your duties Complete timesheets, expenses claims and appraisals in a timely manner as specified by Stakeholders Maintain an up to date training record and submit to your line manager at least every 6 months for review, making updates and amendments as necessary Read and Understand all assigned SOPs via the EQMS system in the timeframe specified Ensure confidential information pertaining to the company is not divulged to 3rd parties with appropriate legal framework or permission Use of IT equipment (e.g. phones, laptops, etc.) is in line with the appropriate company policies SCIENCE & RESEARCH To actively support internal research programs and ensure timely delivery of these projects as all others in the portfolio. Ensure you remain up to date with current trends and changes within the specialist field Encourage and support the application of rigorous scientific approaches and the use of peer reviewed journal material in customer-oriented documentation (e.g. reports) Actively build and improve our IP portfolio with technology, know-how and filing patents as required. Participate in scientific discussions and industry/advocacy groups, professional organisations and Scientific Roundtables involving the team and third parties (e.g. clients/other Contract Development and Manufacturing Organisations/Universities) Prepare and distribute internally key findings from scientific conferences and webinars. CONTINUOUS IMPROVEMENT To identify new areas of technical, process, equipment, and capability development for the company’s teams within your specialisation. Lead selected improvement deployment at the company into a commercially viable offering/services. Provide training and knowledge sessions to the internal teams. Conduct internal training for R&D and Business Development personnel. Identify, suggest and support CapEx purchases for subsequent years/periods with a view to ensuring we maintain our current business levels or growth. Contribute to the assessment of additional training requirements for analytical staff related to separation sciences. Take ownership for own training and development, highlighting to management where you feel further training is required. QUALITY & REGULATORY COMPLIANCE Ensure all assigned Standard Operating Procedures (SOPs) are read and understood within the requested timeframe, seeking clarification on any points not understood or that can be executed practicably immediately. Contribute to the authoring of SOPs and Business Operating Procedures (BOPs) as required. Ensure periodic reviews are conducted in timely manners and are not delayed. Ensure your training record is always up to date and complete (audit ready) Responsible for ensuring areas of Non-compliance are brought to the attention of relevant personnel and/or line manager Leading by example, ensuring all data recorded aligns to the company’s Good Documentation Practice procedures and ALCOA Contribute to Quality investigations relevant to your specialist area. Investigating OOS (out of specification) / OOT (out of trend) results and implementing CAPAs related to your specialist area Contribute to the authoring of SOPs and Business Operating Procedures (BOPs) as required. Ensure your training record is up to date and complete at all times (audit ready). Completing assigned Change Controls, Deviations and CAPAs in designated timelines. ROLE CONTEXT COMMUNICATION & COLLABORATION To ensure good communication and collaboration with all other groups on: Health, Safety and Environmental concerns Training and Personal development Managing and sharing the facilities and capabilities Laboratory improvements and suggestions Capability enhancement Resource Management Politically astute with excellent interpersonal skills and ability to express information and ideas in a manner that is appropriate, concise and accurate. Excellent customer related experience and client facing skills. Ability to communicate and work with personnel of all levels, internally and externally. Read, analyse, and interpret complex documents. Ability to write highly complex analytical reports, routine business correspondence, and technical procedural instructions. Thorough working knowledge of the company’s services, contract development / research, pharmaceutical and biotech industries Proven flexibility in adjusting to a rapidly evolving workload. Always displays adherence to and promotion of the company values. SKILLS & EXPERIENCE Previous experience of working in a lab-based environment (can be previous work or academic experience). Strong leadership skills and leading by example at all times. Awareness of regulatory requirements e.g. Control of Substances Hazardous to Health (COSHH), Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). Excellent communication skills to articulate complex processes and systems. Highly organised with data driven decision making skills. Ability to manage multiple projects concurrently. Knowledge of IT software such as Word, Excel and Outlook. Detail orientated person and highly organised. Confident working in a team and using own initiative. Proven flexibility in adjusting to a rapidly evolving workload and remaining calm under pressure. Displays adherence to and promotion of the company values at all times. Takes ownership for own personal development. Excellent customer related experience and client facing skills. Read, analyse, and interpret complex documents. Ability to write highly complex analytical reports, routine business correspondence, and technical procedural instructions. EDUCATION, EXPERIENCE & RELEVANT SKILLS EDUCATION & QUALIFICATION A first degree in a science, pharmacy or relevant disciple 2.1 or above is required. Extensive experience in specialised field PhD preferable