Senior Scientist - HPLC, KF, UV-Vis, cGMP

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  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.

The Analytical Research and Development (ARD) group for new chemical entities (NCEs) supports development of solid oral dosage forms from First in Human (FIH) clinical studies up to commercialization, using common to state-of-the-art analytical technologies while maintaining Good Laboratory Practices (GLP/GxP).

In this position you will primarily support routine testing of NCEs, with potentially some opportunities for analytical method development. The candidate will assist with basic and novel experimental approaches to answer scientific questions with the overall goal of developing and optimizing NCE drug product formulations. Working closely with analytical and formulation scientists, the candidate will develop productive collaborations and communications both within and across various scientific teams.

Major Responsibilities

•Analytical characterization and assessment of clinical trial supplies (e.g. GMP compliant stability and release testing for both drug substances and drug products)

•Review and approve data of other scientists

•Design and execute development and validation experiments

•Understand and adhere to corporate standards regarding code of conduct, safety, and GxP compliance.

•Responsible for compliance with all applicable Client policies and procedures.

•Documents experimental data appropriately in laboratory documentation system and technical memos. Contributes to writing technical reports.

•Maintains laboratory equipment and optimize laboratory operations for safe and efficient use of time and resources.

•Troubleshoots equipment and experimental problems. Assists junior scientists with troubleshooting.

•Leads initiatives towards continuous improvement activities.

•Willingness to learn new analytical techniques as opportunities arise.

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.

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  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.

The Analytical Research and Development (ARD) group for new chemical entities (NCEs) supports development of solid oral dosage forms from First in Human (FIH) clinical studies up to commercialization, using common to state-of-the-art analytical technologies while maintaining Good Laboratory Practices (GLP/GxP).

In this position you will primarily support routine testing of NCEs, with potentially some opportunities for analytical method development. The candidate will assist with basic and novel experimental approaches to answer scientific questions with the overall goal of developing and optimizing NCE drug product formulations. Working closely with analytical and formulation scientists, the candidate will develop productive collaborations and communications both within and across various scientific teams.

Major Responsibilities

•Analytical characterization and assessment of clinical trial supplies (e.g. GMP compliant stability and release testing for both drug substances and drug products)

•Review and approve data of other scientists

•Design and execute development and validation experiments

•Understand and adhere to corporate standards regarding code of conduct, safety, and GxP compliance.

•Responsible for compliance with all applicable Client policies and procedures.

•Documents experimental data appropriately in laboratory documentation system and technical memos. Contributes to writing technical reports.

•Maintains laboratory equipment and optimize laboratory operations for safe and efficient use of time and resources.

•Troubleshoots equipment and experimental problems. Assists junior scientists with troubleshooting.

•Leads initiatives towards continuous improvement activities.

•Willingness to learn new analytical techniques as opportunities arise.

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.

Education and Experience:  

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years).

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:  

At least 1 year of experience in a regulated cGMP LabAt least 4 years of experience in analytical methodology, such as chromatography (HPLC/GC/IC), KF, UV and common compendial methods required. Experience in some specialty techniques required (LCMS, GCMS, PXRD, ICP, Dissolution, Disintegration).Experienced in laboratory systems (LIMS, CDS, ELN) required.Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to utilize Microsoft Excel and Word to perform tasks Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Proven ability in technical writing skills Time management and project management skills 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. 

Education and Experience:  

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years).

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:  

At least 1 year of experience in a regulated cGMP LabAt least 4 years of experience in analytical methodology, such as chromatography (HPLC/GC/IC), KF, UV and common compendial methods required. Experience in some specialty techniques required (LCMS, GCMS, PXRD, ICP, Dissolution, Disintegration).Experienced in laboratory systems (LIMS, CDS, ELN) required.Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to utilize Microsoft Excel and Word to perform tasks Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Proven ability in technical writing skills Time management and project management skills 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.