Senior Scientist

Job Opportunity – Senior Scientist 

Who we are 

Nanopharm, an Aptar Pharma Company, is a world leading specialist contract research and development organization offering product development services for orally inhaled and nasal drug products (OINDPs).

Nanopharm operates a fee-for-service model, helping its clients navigate the scientific, technical and regulatory challenges in developing nasal and respiratory drug products from discovery through to clinical investigations (‘IND’). Its service offerings provide the most efficient path to success for its clients by providing an integrated product development service covering:

Advanced materials characterization Analytical method development Formulation development and testing Inhaled biopharmaceutics

These early phase services aid successful product development by understanding how material properties and processing conditions influence product functionality and therefore reduce risks and expedite drug development timelines. Nanopharm’s proprietary technology and analytical platforms for advanced materials characterization, formulation & device development and in-silico modelling of in vivo behaviour, have provided Nanopharm a technical competitive edge, helping it become an international market leader. For more information visit:

You should work here because we:

Attract and develop high performing people. Promote a diverse and inclusive work environment. Allow for failure by allowing people to make mistakes through an open and trusting environment. Invest in the development of employees through local, regional and global career opportunities. Contribute to the communities where we reside.

What’s new with Aptar

We have an exciting position open at Nanopharm, which is an Aptar Pharma Company:

Senior Scientist reporting to our Principal Scientist. These positions will be based in Cwmbran and will involve conducting pharmaceutical product analysis for our customers to a high degree of precision and efficiency.

This is how your journey begins:

Role Overview

Support the Principal Scientist 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, our 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 Aptar / Nanopharm 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.

Basics

Promote Nanopharm & Aptar’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 3rd parties with appropriate legal framework or permission. Use of IT equipment (e.g. phones, laptops, etc.) is in line with the appropriate Aptar policies. Maintain attributable, legible, contemporaneous, original and accurate records of all official matters.

People

To inspire all departmental team members by personal example and good work ethic, ensuring alignment to the work being conducted to the values, vision and core strategy. Ensuring the scientific team working on projects within the group/project team are sufficiently trained and competent to perform the requested tasks. Support and deputise for the Principal Scientist 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 team members to ensure experimental tasks are carried out with scientific rigour and in accordance with appropriate SOPs.

Science & Research

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

Quality & Regulatory Compliance

Support the Principal Scientist in ensuring work is conducted to Good Manufacturing Practice (GMP) standards, ensuring all elements of the work meet the standards required. Leading by example, ensuring all data recorded aligns to Nanopharm’s Good Documentation Practice procedures and ALCOA+. 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. Ensure your training record is up to date and complete at all times (audit ready). Review of work records and providing management team with evidence of ongoing competency assessments. Approval of routine (daily monthly annual) quality checks, trend analysis of these checks.

Continuous Improvement

Plan, design and implement initiatives and recommendations to progress work programs To identify inefficiencies and improvements in workflows, processes and systems honestly and promptly. To complete improvement projects on-time, to-track and in-full, where assigned. Demonstrate a continued commitment and personal drive to continuous education, learning and personal development

Customers & Service

Attend project team meetings as requested/selected. Communicating issues on projects and programs immediately to your Principal Scientist (ensuring unsanctioned or unapproved work does not continue). Lead by example, treating our customers ethically, with respect and demonstrating exemplar levels of honesty and integrity with the work we do. Supporting the writing of reports, ensuring data is presented to the highest levels of quality with the minimum of errors and changes required. Present data/technical results diligently internally and externally, communicating clearly and responsibly.

Health Safety & the Environment

Demonstrate and support high levels of Health, Safety and Environmental awareness regulations, initiatives and procedures seeking to improve all three wherever possible within Nanopharm. Enhance the health, safety and wellbeing of our people. Ensuring that you are suitably trained and experienced to conduct your work safely. Ensuring that generated waste is properly disposed of and managed. Irresponsible disposal into the environment must be avoided. Ensure any accidents you are involved with are logged correctly (accident book or EHStar) and promptly and to be involved with subsequent investigations as required. Responsible for ensuring any risks identified are brought to the attention of the Health & Safety lead

Systems and Processes

Contributing to line manager systems and processes, ensuring they are fit for use always and challenging and improving if necessary, to ensure compliance with quality processes, systems and technical excellence in relevant field/group. Author and review SOPs for equipment and processes as requested. Identify, discuss and deploy efficiency gains in the laboratory and associated analysis processes. Ensure experimental tasks are carried out with scientific rigour and in accordance with SOPs. Ensure your data recording practices are aligned to ALCOA+ and are as efficient as possible. Ensure issues with IT systems are logged with a ticket. Do not allow issues to continue without resolution. Assist with the compilation and roll out of training modules to all team members as required, advancing our skills/capabilities continuously.

Capabilities & technology

Ordering process specific consumables and/or ensuring good supplies are in stock for continuity of working productivity. Support the evaluation, selection, procurement and implementation of new equipment for Nanopharm. Assist with ensuring safe and efficient running of the laboratories/facilities and raise any issues with your Principal Scientist or Operations Coordination to ensure effective actions are put in place. Ensure excellent levels of housekeeping and conduct informal reviews/audits as required to ensure standards are maintained after your team has conducted work in those areas. Communicate to the line manager regarding any additional IT support or technology required for work conducted by the team.

Role Context

Communication & Collaboration

To ensure good communication and collaboration with all other Nanopharm groups on:

Resource management Health, Safety and Environmental concerns Training and Personal development With customers on how their programs are progressing and supporting prompt issue resolution Managing and sharing the facilities and capabilities

Science & Research

To work diligently with experimental testing of pharmaceutical products. Record data accurately, contemporaneously and discuss results/findings with senior scientific members of the team. Reviewing your own data and ensuring alignment to expected standards, working to understand trends and patterns in the data that may be present. Seeking to understand the fundamental scientific concepts behind how products work and the analytical tests being performed. Read through analytical methodologies, which are carried out in the laboratories and raise any queries to the Senior Scientist prior to the start of testing.

Quality & Regulatory Compliance

Record data competently, either in written form or electronically, in accordance to GMP (Good Manufacturing/Laboratory Practice) and health authority regulations. Use scientific instruments with care and control as trained to, ensuring proper calibrations are complete or conducting calibrations as may be necessary. Prepare analysis solutions, mobile phases and diluents with accuracy and in accordance with the methods and procedures provided. To conduct assignments in a timely manner ensuring delivery to the agreed project plan. Use analytical materials, consumables and test items in a responsible manner, ensuring good stock levels are maintained during the working day and being responsible to re-order anything that is necessary in a timely manner. Responsible and accountable for the accurate and contemporaneous data recording for yourself in accordance with the principals of ALCOA+ (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available). 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. Ensure your training record is up to date and complete at all times (audit ready)

Heath Safety & The Environment

To work in a safe manner, taking care of one’s own health and safety as well as your colleagues. Wear and use the provided PPE and safety equipment as trained and required. Ensuring COSHH (Control of Substances Hazardous to Health) assessments are read and understood on substances being used actively. Ensuring the work you conduct is safe, well considered and if unsure raise promptly to senior members of the team. Ensuring that generated waste is properly disposed of and managed. Irresponsible disposal into the environment must be avoided. Ensure any accidents are logged correctly and promptly in line with the internal reporting procedures. Ensure any improvements in safety are adopted quickly and correctly.

Systems & Processes

To read and understand, executing tests and procedures in accordance with Standard Operating Procedures (SOPs) and Analytical methods. Ensure issues with IT systems are logged with a ticket promptly and raise to senior members of the team. Do not allow issues to continue without resolution.

Capability & Technology

Ensure excellent levels of housekeeping to ensure standards are maintained after you have finished conducting laboratory work. Ensure issues, problems or improvements with the use of the facilities is communicated to senior members of the team promptly.

Education & Qualification

Preferably a first degree in a science, pharmacy or relevant discipline of grade 2.1 or above

Skills & Experience

Experience in Inhalation/respiratory product development or research Understanding of regulatory requirements e.g. GMP, ICH, COSHH Proven team player with experience in providing guidance to colleagues or direct / indirect reports Expected to have some relevant scientific/technical experience whether from rising through Nanopharm system or another appropriate pharmaceutical environment / academic institution Some customer related experience and client facing skills would be advantageous Demonstrated proactive and organised approach, able to exert influence over those whom they do not have direct authority and proven ability to prioritise and manage multiple tasks Ability to communicate and work with personnel of all levels, internally and externally 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

What you will bring on the journey

Preferably a first degree in a science, pharmacy or relevant discipline with a significant analytical component of grade 2.1 or above

Experience:

Experience in Inhalation/respiratory product development or research Understanding of regulatory requirements e.g. Good Manufacturing Practice (GMP), International Council for Harmonisation (ICH), Control of Substances Hazardous to Health (COSHH) Experience with High Performance Liquid Chromatography (preferred). Experience in a GMP compliant environment (preferred). Experience of working in a lab based environment.

 Ability to travel: occasional travel for training, inter-site support and customer/3rd party assistance. Travel to split site may also be required for training purposes.

 Other requirements:

Detail orientated person and highly organised. Positive and curious attitude to own growth and development. 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

What we offer:

An exciting, diverse and value based working environment Award-winning corporate university offering personal development and training opportunities. Competitive base salary and performance-based bonus plan. Innovative benefits plan, which includes: medical, life, disability and wellness.

Be You. Be Aptar

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