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Laboratory Supervisor (Inhalations)

Pharmaceutical Product Development (PPD)

IE-Athlone-Athlone IE Business & Tech Pk

Laboratory Supervisor – Inhalation

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health .You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of deliveringlife-saving therapies to patients.

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

Our team is expanding due to exciting new projects and we are looking for a Laboratory Supervisor to join our Inhalation group within our Pharma team. This group is responsible for conducting device performance, aerosol and particle characterisation and impactor testing for a variety of inhalation devices:pMDIs, DPIs,nebulizers, nasal sprays and novel devices.

As a Laboratory Supervisor you will provide line-level management, coordination of resources and work schedules for laboratory activities.

Essential Functions:   Oversee daily operations and assists in preparation and implementation of company policies, quality systems and training programs. Organizes, schedules and supervises laboratory resources for group's project activities and updates project status. Ensure projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed. Ensure that lab staff continue to be developed to keep pace with department goals and growth Responds to client questions and needs, coordinates client communication and records meeting minutes. Performs lab work in accordance with client protocols, methods and requirements. Prepares study protocols, project status reports, final study reports and other project-related technical documentation. Designs experimental study and participates in technical troubleshooting. Reviews, interprets and analyses data for technical quality and compliance to protocols, methods and SOPs. Reviews laboratory investigations and deviation. Assists group leaders in their responsibilities. Assists in preparation and implementation of PPD/client SOPs and company operational policies, as well as assists in Client & Authorities audits. Ensures adherence to SOPs, safety standards and company policies.

Laboratory Supervisor – Inhalation

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health .You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of deliveringlife-saving therapies to patients.

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

Our team is expanding due to exciting new projects and we are looking for a Laboratory Supervisor to join our Inhalation group within our Pharma team. This group is responsible for conducting device performance, aerosol and particle characterisation and impactor testing for a variety of inhalation devices:pMDIs, DPIs,nebulizers, nasal sprays and novel devices.

As a Laboratory Supervisor you will provide line-level management, coordination of resources and work schedules for laboratory activities.

Essential Functions:   Oversee daily operations and assists in preparation and implementation of company policies, quality systems and training programs. Organizes, schedules and supervises laboratory resources for group's project activities and updates project status. Ensure projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed. Ensure that lab staff continue to be developed to keep pace with department goals and growth Responds to client questions and needs, coordinates client communication and records meeting minutes. Performs lab work in accordance with client protocols, methods and requirements. Prepares study protocols, project status reports, final study reports and other project-related technical documentation. Designs experimental study and participates in technical troubleshooting. Reviews, interprets and analyses data for technical quality and compliance to protocols, methods and SOPs. Reviews laboratory investigations and deviation. Assists group leaders in their responsibilities. Assists in preparation and implementation of PPD/client SOPs and company operational policies, as well as assists in Client & Authorities audits. Ensures adherence to SOPs, safety standards and company policies.

Education and Experience:  Min. Degree level education in Relevant scientific field (inc. Chemistry) Min. 5 years relevant experience within an analytical lab environment 1 year of people management responsibility in a lab environment Analytical experience must include analytical testing support for inhalation devices (pMDIs, DPIs,nebulizers, nasal sprays and novel devices)

Knowledge, Skills and Abilities: Demonstrated proficiency within a lab environment should includeHPLC analysis. Other techniques may include Karl Fischer, GC and Particle Size determination. Testing experience ofinhalation devicessuch as pMDIs, DPIs,nebulizers, nasal sprays and novel device using techniques such as cascade impaction, dose delivery/Single actuation content, particle size analysis, and spray characterisation. Proven leadership skills Ability to train and mentor junior staff Demonstrated ability to be project solution driven Good written and oral communication skills as well as presentation skills Can independently perform root cause analysis for method investigations Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.) Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs Ability to independently optimize analytical methods Project and time management skills Knowledge of Industry Regulatory/CMC guidance for Inhaled products would be an advantage

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team.We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development program , ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We havea flexible working culture , where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.We are a global organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

If you are interested in learning more, please send your resume to michelle.hand@ppdi.com, and we’ll set up a time to connect!

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.

#LI-MH1

Education and Experience:  Min. Degree level education in Relevant scientific field (inc. Chemistry) Min. 5 years relevant experience within an analytical lab environment 1 year of people management responsibility in a lab environment Analytical experience must include analytical testing support for inhalation devices (pMDIs, DPIs,nebulizers, nasal sprays and novel devices)

Knowledge, Skills and Abilities: Demonstrated proficiency within a lab environment should includeHPLC analysis. Other techniques may include Karl Fischer, GC and Particle Size determination. Testing experience ofinhalation devicessuch as pMDIs, DPIs,nebulizers, nasal sprays and novel device using techniques such as cascade impaction, dose delivery/Single actuation content, particle size analysis, and spray characterisation. Proven leadership skills Ability to train and mentor junior staff Demonstrated ability to be project solution driven Good written and oral communication skills as well as presentation skills Can independently perform root cause analysis for method investigations Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.) Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs Ability to independently optimize analytical methods Project and time management skills Knowledge of Industry Regulatory/CMC guidance for Inhaled products would be an advantage

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team.We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development program , ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We havea flexible working culture , where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.We are a global organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

If you are interested in learning more, please send your resume to michelle.hand@ppdi.com, and we’ll set up a time to connect!

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.

#LI-MH1

Job posted: 2021-02-10

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