Specialist (Formulation)

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