Senior Scientist - Method Development , HPLC , Ion Chromatography

Submission for the position: Senior Scientist - Method Development , HPLC , Ion Chromatography - (Job Number: 185614)

In labs and health care facilities worldwide- HERE WE ARE

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

As a Senior Scientist,you will join the Analytical Development group supporting the drug development programs onsite at the customer site as a member of the chromatography Subject Matter Expert (SME) team. The chromatography SME team is responsible for the development of HPLC methods required for Drug Substance and Drug Product across all the customer clinical programs, utilizing statistical design of experiment approaches (DoE) and in-silico tools to identify the most robust operating space. You will have strong sample preparation skills, have hands-on experimental work, and expertise in laboratory techniques commonly used in the analysis of pharmaceutical products, especially HPLC and MS.

Additional key responsibilities for the role on site at a major pharmaceutical company:Develop methods to determine potency, purity, and stability for drug substances (DS) and/or drug products (DP)

Designs, executes, and interprets experiments with high degree of reliability, independence, and attention to detailMaintain accurate records of experiments and results in a laboratory notebook and authors reports as assigned- Utilizes software tools (Fusion QbD, DryLab, etc.) to model experimental design space in order to identify a robust operation regionMaintains general lab equipment, including HPLCsDevelops sample preparation procedures suitable for quantitative analyses

Troubleshoots issues encountered with final DS and DP HPLC methods

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

Join PPD in our relentless pursuit of excellence - apply now!

In labs and health care facilities worldwide- HERE WE ARE

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

As a Senior Scientist,you will join the Analytical Development group supporting the drug development programs onsite at the customer site as a member of the chromatography Subject Matter Expert (SME) team. The chromatography SME team is responsible for the development of HPLC methods required for Drug Substance and Drug Product across all the customer clinical programs, utilizing statistical design of experiment approaches (DoE) and in-silico tools to identify the most robust operating space. You will have strong sample preparation skills, have hands-on experimental work, and expertise in laboratory techniques commonly used in the analysis of pharmaceutical products, especially HPLC and MS.

Additional key responsibilities for the role on site at a major pharmaceutical company:Develop methods to determine potency, purity, and stability for drug substances (DS) and/or drug products (DP)

Designs, executes, and interprets experiments with high degree of reliability, independence, and attention to detailMaintain accurate records of experiments and results in a laboratory notebook and authors reports as assigned- Utilizes software tools (Fusion QbD, DryLab, etc.) to model experimental design space in order to identify a robust operation regionMaintains general lab equipment, including HPLCsDevelops sample preparation procedures suitable for quantitative analyses

Troubleshoots issues encountered with final DS and DP HPLC methods

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

Join PPD in our relentless pursuit of excellence - apply now!

Education and Experience: Bachelor's degree in physical sciences (Analytical Chemistry, Chemistry, etc.) or equivalent and relevant formal academic/ vocational qualification Previous industry experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years) working in drug substance and drug product support Master's degree in physical sciences (Analytical Chemistry, Chemistry, etc.) with industry experience comparable to 2 years Ph.D. in physical sciences (Analytical Chemistry, Chemistry, etc.) with industry experience comparable to 0-2 years Preferred Experience: Familiarity with alternate HPLC modes including ion chromatography and supercritical fluid chromatography Knowledge of various detection techniques include optical detection and mass spectrometry is preferred

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities: In-depth knowledge of HPLC, both theory and practice, required- MS a plus Knowledge of statistical design of experiment approaches using Fusion QbD, Drylab, and JMP preferred Knowledge of various detection techniques include optical detection and mass spectrometry is preferred Solid understanding and knowledge of general chemistry Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to utilize Microsoft Excel and Work to perform tasks Empower software experience preferred Maintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOP Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects essential Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to train junior staff

Working Environment:  

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role:  Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.  Able to work upright and stationary and/or standing for typical working hours.   Able to lift and move objects up to 25 pounds   Able to work in non-traditional work environments.   Able to use and learn standard office equipment and technology with proficiency.   May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.  Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.  PPD Defining Principles: 

- 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 *LI-NW1

Education and Experience: Bachelor's degree in physical sciences (Analytical Chemistry, Chemistry, etc.) or equivalent and relevant formal academic/ vocational qualification Previous industry experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years) working in drug substance and drug product support Master's degree in physical sciences (Analytical Chemistry, Chemistry, etc.) with industry experience comparable to 2 years Ph.D. in physical sciences (Analytical Chemistry, Chemistry, etc.) with industry experience comparable to 0-2 years Preferred Experience: Familiarity with alternate HPLC modes including ion chromatography and supercritical fluid chromatography Knowledge of various detection techniques include optical detection and mass spectrometry is preferred

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities: In-depth knowledge of HPLC, both theory and practice, required- MS a plus Knowledge of statistical design of experiment approaches using Fusion QbD, Drylab, and JMP preferred Knowledge of various detection techniques include optical detection and mass spectrometry is preferred Solid understanding and knowledge of general chemistry Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to utilize Microsoft Excel and Work to perform tasks Empower software experience preferred Maintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOP Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects essential Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to train junior staff

Working Environment:  

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role:  Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.  Able to work upright and stationary and/or standing for typical working hours.   Able to lift and move objects up to 25 pounds   Able to work in non-traditional work environments.   Able to use and learn standard office equipment and technology with proficiency.   May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.  Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.  PPD Defining Principles: 

- 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 *LI-NW1 Submission for the position: Senior Scientist - Method Development , HPLC , Ion Chromatography - (Job Number: 185614)