Research Scientist - Analytical Chemist - Support for Process Chemistry

Submission for the position: Research Scientist - Analytical Chemist - Support for Process Chemistry - (Job Number: 178840)

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.

In this position you will be responsible for method development/validation experiment/reports, performing laboratory research and development under minimal guidance.

Responsibilities will include, but are not limited to, the following:

• Support drug product formulation and process development including characterization of the process and finished product.

• Generate data and reports for the preparation of method development and stability studies.

• Performs troubleshooting within method guidance.

• Other duties as assigned by the supervisor.

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.

In this position you will be responsible for method development/validation experiment/reports, performing laboratory research and development under minimal guidance.

Responsibilities will include, but are not limited to, the following:

• Support drug product formulation and process development including characterization of the process and finished product.

• Generate data and reports for the preparation of method development and stability studies.

• Performs troubleshooting within method guidance.

• Other duties as assigned by the supervisor.

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 8 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:  

Full knowledge of technical operating systems Experience in analytical development of DP. Experience in generating method development/pre-validation report, stability data report Experience in Empower required. Experience in dissolution methods developing and testing, forced degradation studies and DOE support Extensive laboratory experience with and in-depth knowledge of conventional laboratory characterization techniques such as HPLC/UPLC, dissolution, KF and wet chemistry is a must. Fluency in formulation development, pharmaceutical processing or pharmaceutical sciences is expected. Strong problem-solving and troubleshooting skills. Strong capabilities in experimental design and execution. Ability to work independently Familiar with USP and other compendia Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance Ability to independently optimize analytical methods Ability to independently perform root cause analysis for method investigations Proven technical writing skills Effective written and oral communication skills as well as presentation skills Time management and project management skills Ability to mentor others on technical operating systems Ability to independently review and understand project proposals/plans Ability to work in a collaborative work environment with a team

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 8 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:  

Full knowledge of technical operating systems Experience in analytical development of DP. Experience in generating method development/pre-validation report, stability data report Experience in Empower required. Experience in dissolution methods developing and testing, forced degradation studies and DOE support Extensive laboratory experience with and in-depth knowledge of conventional laboratory characterization techniques such as HPLC/UPLC, dissolution, KF and wet chemistry is a must. Fluency in formulation development, pharmaceutical processing or pharmaceutical sciences is expected. Strong problem-solving and troubleshooting skills. Strong capabilities in experimental design and execution. Ability to work independently Familiar with USP and other compendia Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance Ability to independently optimize analytical methods Ability to independently perform root cause analysis for method investigations Proven technical writing skills Effective written and oral communication skills as well as presentation skills Time management and project management skills Ability to mentor others on technical operating systems Ability to independently review and understand project proposals/plans Ability to work in a collaborative work environment with a team

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. 

Submission for the position: Research Scientist - Analytical Chemist - Support for Process Chemistry - (Job Number: 178840)