Senior Scientist - Analytical Testing & CRO Services - Inhalation & Nasal Drug Delivery in Newport

Spherical Search has recently partnered with a well-established Analytical Testing and CRO services organisation specialising in inhalation and nasal drug delivery. The company works with a broad range of pharmaceutical, biologics, and device organisations on a global scale. We are currently seeking a Senior Scientist to join the team in an on-site role, based within a commutable distance of Cwmbran, Wales.

ROLE OVERVIEW

• Support the Associate Manager, Pharmaceutical Development with the organising and planning of project activities with your group utilising the most effective use of equipment, resources and skills dependent upon customer requirements for assigned projects.
• Provide solid scientific and technical support to the team of scientists and analysts, customers and project teams as required.
• Provide and support training of analysts and team members.

LIVE OUR VALUES

• Ensure you are an advocate and role model for exemplary performance aligned to the company values in everything you do:
• We respect and trust people
• We believe in the value of each individual
• We challenge ourselves to take initiative and develop our full potential
• We promote teamwork and cooperation at all levels
• We strive for relationships that are based on openness, honesty and feedback
• We act ethically and responsibly, holding ourselves accountable to all stakeholders

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.

• Promote the organisation’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 QMS system in the timeframe specified.
• Ensure confidential information pertaining to the company is not divulged to third parties without appropriate legal framework or permission.
• Use of IT equipment (e.g. phones, laptops, etc.) is in line with appropriate company policies.
• Maintain attributable, legible, contemporaneous, original and accurate records of all official matters.

PEOPLE

• Inspire all departmental team members by personal example and good work ethic, ensuring alignment of work conducted to the values, vision and core strategy.
• Ensure the scientific team working on projects within the group / project team are sufficiently trained and competent to perform requested tasks.
• Support and deputise for the Associate Manager, Pharmaceutical Development as required, representing your team and presenting a broad overview of progress, successes and challenges to the Head of Department.
• Participate in the recruitment process of new team members.
• Provide support and supervision as required to ensure experimental tasks are carried out with scientific rigour and in accordance with appropriate SOPs.

SCIENCE & RESEARCH

• Provide scientific and technical leadership to project teams and clients.
• Provide training (either externally or internally) in specialist or scientific skills.
• Conduct data analysis and manipulation and support the assessment and interpretation of work conducted.
• Make comprehensive records of all work and write formal reports where requested.
• Author and support the production of material intended for publication, including conference posters and peer-reviewed journals.
• Act as an ambassador in specialist areas and actively participate in the scientific and industrial community.
• Perform research and development activities delivering new technologies, processes or knowledge as agreed with group leadership.
• Present data and technical results diligently internally, communicating clearly and responsibly.
• Review new developments in the area and remain up to date with current literature.
• Review and approve analytical data and results.
• Provide support and supervision as required to ensure experimental tasks are completed accurately.
• Assist in, or perform, research, method development and validation for new methods or services offered.

QUALITY & REGULATORY COMPLIANCE

• Support the Associate Manager, Pharmaceutical Development in ensuring work is conducted to Good Manufacturing Practice (GMP) standards and meets required expectations.
• Lead by example, ensuring all data recorded aligns to Good Documentation Practice procedures and ALCOA+.
• Ensure all assigned SOPs are read and understood within required timeframes.
• Ensure your training record is up to date and audit ready at all times.
• Review work records and provide evidence of ongoing competency assessments.
• Approve routine quality checks and support trend analysis activities.

CONTINUOUS IMPROVEMENT

• Plan, design and implement initiatives and recommendations to progress work programmes.
• Identify inefficiencies and improvements in workflows, processes and systems promptly.
• Complete assigned improvement projects on-time and in-full.
• Demonstrate continued commitment to continuous education, learning and personal development.

CUSTOMERS & SERVICE

• Attend project team meetings as requested or selected.
• Communicate issues on projects and programmes immediately to the Associate Manager, Pharmaceutical Development to prevent unapproved work continuing.
• Lead by example, treating customers ethically and with respect.
• Support report writing to ensure data is presented to the highest quality standards.
• Present data and technical results diligently both internally and externally, communicating clearly and responsibly.

HEALTH, SAFETY & THE ENVIRONMENT

• Demonstrate and support high levels of health, safety and environmental awareness, initiatives and procedures.
• Enhance the health, safety and wellbeing of colleagues.
• Ensure you are suitably trained and experienced to conduct work safely.
• Ensure generated waste is disposed of and managed responsibly.
• Ensure accidents are logged correctly and support subsequent investigations.
• Ensure identified risks are raised promptly with the appropriate health and safety lead.

SYSTEMS AND PROCESSES

• Contribute to line manager systems and processes, ensuring they remain fit for purpose and compliant.
• Author and review SOPs for equipment and processes as requested.
• Identify and deploy efficiency gains in laboratory and analysis processes.
• Ensure experimental tasks are carried out with scientific rigour and in accordance with SOPs.
• Ensure data recording practices align with ALCOA+ principles.
• Ensure IT system issues are logged promptly and resolved.
• Assist with the compilation and roll-out of training modules as required.

CAPABILITIES & TECHNOLOGY

• Order process-specific consumables and ensure continuity of supplies.
• Support evaluation, selection, procurement and implementation of new equipment.
• Assist in ensuring safe and efficient operation of laboratories and facilities.
• Maintain excellent levels of housekeeping and conduct informal reviews or audits.
• Communicate additional IT or technology needs to line management.

ROLE CONTEXT

COMMUNICATION & COLLABORATION

• Ensure effective communication and collaboration with other internal groups on:
• Resource management
• Health, safety and environmental concerns
• Training and personal development
• Customer programme progression and issue resolution
• Management and sharing of facilities and capabilities

INTERFACES / RELATIONSHIPS

• Internal: Line Manager, Senior Scientists, Pharmaceutical Analysts, Project Management, Quality Assurance
• External: Clients, stakeholders, regulatory authorities, external service vendors (CMO / CRO), equipment providers, academia, professional bodies and key opinion leaders

SCOPE

• People / Reports: Deputise for line manager in absence and oversee Pharmaceutical Analysts as required.
• Laboratory: Ownership of designated laboratory workspace.
• Equipment: Ownership of assigned IT equipment.

ENVIRONMENT

• Place of Work: Office and laboratory based. Laboratory presence is encouraged to ensure standards are maintained.
• HOME WORKING: Requires prior approval from line manager.
• Travel: Up to 10% of time away from site for training, inter-site support or customer / third-party assistance. Travel to split site may be required.
• Working Arrangement: Standard: 37.5 hours per week, Monday to Friday, core hours 09:00–17:00. Exceptions: Occasional evening or weekend work or travel as arranged with line manager.

EDUCATION, EXPERIENCE & RELEVANT SKILLS

• EDUCATION & QUALIFICATION: Preferably a first degree in a science, pharmacy or relevant discipline of grade 2.1 or above.
• SKILLS & EXPERIENCE:
• Experience in inhalation or respiratory product development or research.
• Understanding of regulatory requirements (e.g. GMP, ICH, COSHH).
• Proven team player with experience providing guidance to colleagues.
• Relevant scientific or technical experience gained within a pharmaceutical or academic environment.
• Some customer-facing experience is advantageous.
• Proactive and organised with the ability to prioritise and manage multiple tasks.
• Ability to communicate effectively with personnel at all levels.
• Proven flexibility in adjusting to evolving workloads and remaining calm under pressure.
• Demonstrates adherence to and promotion of company values at all times.