Senior Research Scientist- CE-MS or CE experience

Submission for the position: Senior Research Scientist- CE-MS or CE experience - (Job Number: 169370)Oversees complex analytical development and/or specialty technologies projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.). Provides technical and regulatory consulting to internal groups and clients about their programs. Provides technical guidance and mentorship to senior staff members in performing laboratory activities. Routinely acts as the technical project leader for multiple projects, interacts with clients to provide technical project updates, reviews and evaluates data, writes reports and protocols.

Independently plans the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements. Acts as on-site Subject Matter Expert (SME) for instrumentation / technique / technology. Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical applications. Demonstrates viability of in-house developed methods and methods transferred from clients by designing appropriate validation experiments or other appropriate aspects of specialty methodology or technology. Ability to lead client discussions regarding project definitions, technical information exchanges and discussions of project status. Provides recommendations to clients on technical and regulatory issues. Reviews protocols, project status reports, final study reports and other project-related technical documents. Assists business development group in technical sales and marketing, and in preparation of technical marketing materials, and presents posters and makes podium presentations at conferences. Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.Oversees complex analytical development and/or specialty technologies projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.). Provides technical and regulatory consulting to internal groups and clients about their programs. Provides technical guidance and mentorship to senior staff members in performing laboratory activities. Routinely acts as the technical project leader for multiple projects, interacts with clients to provide technical project updates, reviews and evaluates data, writes reports and protocols.

Independently plans the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements. Acts as on-site Subject Matter Expert (SME) for instrumentation / technique / technology. Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical applications. Demonstrates viability of in-house developed methods and methods transferred from clients by designing appropriate validation experiments or other appropriate aspects of specialty methodology or technology. Ability to lead client discussions regarding project definitions, technical information exchanges and discussions of project status. Provides recommendations to clients on technical and regulatory issues. Reviews protocols, project status reports, final study reports and other project-related technical documents. Assists business development group in technical sales and marketing, and in preparation of technical marketing materials, and presents posters and makes podium presentations at conferences. Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.

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 10 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:

Effective written and oral communication skills as well as presentation skills Knowledge and application of industry best practices not yet represented by global regulatory requirements Full theoretical and hands-on understanding and knowledge of general chemistry and separation science Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance Ability to independently review and understand project proposals/plans Proven ability in technical writing skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to independently optimize analytical methods Time management and project management skills

Qualifications

Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years’) or equivalent combination of education, training, & experience. OR PhD

Knowledge, Skills and Abilities:HPLC, GC, MS, Dissolution Testing, Inhalation Testing (Cascade Impaction, Dose delivery, Particle Size analysis), BioPharmaceutical Testing (ELISA, Gel Electrophoresis), Karl Fischer, UV-Vis, FT-IR, TOCManual dexterity.Communicate effectively and follow detailed written and verbal instruction.Cooperate with coworkers within an organized team environment or work alone with supervision.Manage time effectively to complete assignments in expected time frame.Maintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOP.Proficient in the use of analytical instrumentation, skills in separation science techniques (HPLC, GC and CE) are desired.

Proficient in sample extraction procedures.Ability to plan, schedule and carry out work for successful project completion.Proficient in the operation of the computer and data acquisition programs.Positive attitude and ability to work well with others.Ability to write protocols and reports with minimum supervision

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 10 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:

Effective written and oral communication skills as well as presentation skills Knowledge and application of industry best practices not yet represented by global regulatory requirements Full theoretical and hands-on understanding and knowledge of general chemistry and separation science Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance Ability to independently review and understand project proposals/plans Proven ability in technical writing skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to independently optimize analytical methods Time management and project management skills

Qualifications

Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years’) or equivalent combination of education, training, & experience. OR PhD

Knowledge, Skills and Abilities:HPLC, GC, MS, Dissolution Testing, Inhalation Testing (Cascade Impaction, Dose delivery, Particle Size analysis), BioPharmaceutical Testing (ELISA, Gel Electrophoresis), Karl Fischer, UV-Vis, FT-IR, TOCManual dexterity.Communicate effectively and follow detailed written and verbal instruction.Cooperate with coworkers within an organized team environment or work alone with supervision.Manage time effectively to complete assignments in expected time frame.Maintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOP.Proficient in the use of analytical instrumentation, skills in separation science techniques (HPLC, GC and CE) are desired.

Proficient in sample extraction procedures.Ability to plan, schedule and carry out work for successful project completion.Proficient in the operation of the computer and data acquisition programs.Positive attitude and ability to work well with others.Ability to write protocols and reports with minimum supervision

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: Senior Research Scientist- CE-MS or CE experience - (Job Number: 169370)