Specialist, Formulation

JOB OPPORTUNITY – SPECIALIST, FORMULATION
 

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: www.nanopharm.co.uk 

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: Specialist, Formulation reporting to our Manager, Technical Specialists. 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 AND RESPONSIBILITIES
•    To operate as a Scientific and Technical Expert in your specific speciality.
o    This speciality will be in focused and dedicated field recognised in the industry 
•    To support the Pharmaceutical Development Units (PDUs) in Nanopharm 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:
o    Provides technical experience and support to development teams. 
o    Expected to be a hands-on role where scientist provides practical application of specialist skill e.g. use of specialised instruments
o    Senior user and responsible person for specialist equipment and laboratory areas, in conjunction with the Operations team
o    Learning, teaching, and training of Nanopharm team members.
o    Reviewing reports for technical and scientific accuracy with regards to data analysis or conclusions (but not as a routine reviewer).
o    Involved in customer/stakeholder/sponsor discussions and presentations to ensure the most significant capabilities are made available to these interfaces.
o    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:
o    Participating in calls, workshops, problem solving, technical discussions and project review processes/meetings as required, to leverage your experience and technical capabilities.
o    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 Nanopharm continuously.
o    Present at conferences and publish in peer-reviewed journals.
o    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, Nanopharm team members, academic/industrial partners, regulatory agencies, Aptar Senior Management, Aptar R&D and Aptar Business Development in this area.
•    Assess the applicability and limitations of new technologies within specialist field and make recommendations for use in Nanopharm
•    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 

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 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 Aptar policies

HEALTH SAFETY & THE ENVIRONMENT
•    Ensure there is visible, active commitment to the health, safety, wellbeing, and environmental sustainability practices for those that work with you.
•    Ensuring there is good integration of health and safety management with your activities.
•    Ensure those you work with actively engage and promote good HSE practices in their work.
•    Ensure effective 'upward' communication of HS&ES issues or concerns from people working in your designated lab, on your specialist equipment or processes.
•    Ensure all appropriate risk assessments are completed and an associated action plan, for the work you are engaged in.
•    Ensure adherence to COSHH and Risk assessments for all work with which you are engaged with, whether as a leader or team member.
•    Ensure HSE actions are conducted in a timely and complete manner.

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.
•    Provide training to scientific staff to give confidence to personnel in their ability to conduct laboratory tasks related to their specialism.
•    Clearly communicate and update senior members of the Nanopharm team (Senior Specialists, Principal Scientists, heads of department, etc.) on the status of ongoing tasks throughout the day and raise an errors or issues promptly. 
•    Participate in the recruitment process of new team members (if required).
•    Accountable for identifying any training needs for PDUs and notifying Heads of Department to ensure robust training plans are put in place.
•    Ensuring absences are logged and tracked in the system and diligently approved in a reasonable amount of time.
•    Creating a work environment that ensures good retention of staff, with low levels of turnover, within areas the areas you work in.

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 Nanopharm/Aptar team and third parties (e.g. clients/other Contract Development and Manufacturing Organisations/Universities)
•    Prepare and distribute internally (Nanopharm and Aptar Pharma) key findings from scientific conferences and webinars.

OPERATIONS
•    Technical support to Nanopharm Pharmaceutical Development Units (PDUs) within the realm of your speciality
•    Support data interpretation, problem solving activities and guidance to Nanopharm Pharmaceutical Development Units   

CONTINUOUS IMPROVEMENT
•    To identify new areas of technical, process, equipment, and capability development for Nanopharm teams within your specialisation. 
•    Lead selected improvement deployment at Nanopharm into a commercially viable offering/services.
•    Provide training and knowledge sessions to Nanopharm teams.
•    Conduct internal training for Aptar 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 Nanopharm’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.

SYSTEMS AND PROCESSES
•    Ensure systems and processes are fit for use always, challenging and improving if necessary, supporting the properly managed change/improvement process.
•    Responsible and accountable for ensuring you and your team follow all defined systems and processes completely, adhering to process steps and requirements.
•    Ensure issues with IT systems are logged with a ticket, encouraging your team members to do so promptly. Do not allow issues to continue without resolution.
•    Enable the compilation and roll out of training modules to all team members, advancing our skills/capabilities continuously.

ROLE CONTEXT
COMMUNICATION & COLLABORATION
To ensure good communication and collaboration with all other Nanopharm 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

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

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.

TRAINING
•    None required
LICENCES AND CERTIFICATIONS
•    None required
OTHER QUALIFICATIONS 
•    None required

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:
o    Experience in Inhalation/respiratory product development or research
o    Understanding of regulatory requirements e.g. Good Manufacturing Practice (GMP), International Council for Harmonisation (ICH), Control of Substances Hazardous to Health (COSHH)
o    Experience with High Performance Liquid Chromatography (preferred).
o    Experience in a GMP compliant environment (preferred).
o    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
Aptar is an equal opportunities employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief.
 

LOCATION STATEMENT
For additional information about location requirements, please discuss with the recruiter following submission of your application.