Senior Scientist - Lab Operations and LC-MS/MS Study Support

Submission for the position: Senior Scientist - Lab Operations and LC-MS/MS Study Support - (Job Number: 178258)

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.

Job Duties: Coordinate, schedule, and document the non-Category 1 (e.g. cold storage units and incubators) instrument routine and non routine service and calibrations under the supervision of Subject Matter Expert(s), along with manage the vendor training and logistics. Arrange for new lab instrumentation to be covered by the Laboratory Equipment Maintenance external vendor, which involves obtaining quotes, generating POs, and managing the installation. Support the department purchasing through PO generation and possible coordination of capital requests from the NDB department, which could include scheduling installation with facilities and managing the vendor (both internal and external) logistics. Assist with maintaining inspection ready laboratories, through schedule routine cleaning of the labs with Facilities (e.g. mopping the lab floors and 2x a year rebuffing/waxing the floors) and monthly safety inspections. Prepare solutions, reagents, tube labels, and matrix specific calibration standards and QCs following a written procedure/recipe and document per department SOPs in an electronic laboratory notebook. Assist SMEs with performing basic troubleshooting and testing of sample preparation using the Tecan robotic sample processor to support the regulated bioanalytical teams. May contribute to bioanalytical sample analysis in support of LC-MS/MS assays

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.

Job Duties: Coordinate, schedule, and document the non-Category 1 (e.g. cold storage units and incubators) instrument routine and non routine service and calibrations under the supervision of Subject Matter Expert(s), along with manage the vendor training and logistics. Arrange for new lab instrumentation to be covered by the Laboratory Equipment Maintenance external vendor, which involves obtaining quotes, generating POs, and managing the installation. Support the department purchasing through PO generation and possible coordination of capital requests from the NDB department, which could include scheduling installation with facilities and managing the vendor (both internal and external) logistics. Assist with maintaining inspection ready laboratories, through schedule routine cleaning of the labs with Facilities (e.g. mopping the lab floors and 2x a year rebuffing/waxing the floors) and monthly safety inspections. Prepare solutions, reagents, tube labels, and matrix specific calibration standards and QCs following a written procedure/recipe and document per department SOPs in an electronic laboratory notebook. Assist SMEs with performing basic troubleshooting and testing of sample preparation using the Tecan robotic sample processor to support the regulated bioanalytical teams. May contribute to bioanalytical sample analysis in support of LC-MS/MS assays

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:  

Possess a strong knowledge of basic analytical concepts (concentration units, pH, calibration curves, QCs, compliance, etc.) and basic analytical laboratory operational skills (pipettes, balances, computer skills), etc. Demonstrate the ability to work in a methodical and organized fashion. Understand and follow written methods and documentation best practices to clearly and concisely record laboratory work and equipment maintenance. Have a working knowledge of LC-MS/MS. Exhibita basic understanding of laboratory instrumentation and notebook keeping. Demonstrate a working knowledge of GLPs and general laboratory practices. Possessexcellent communication and organizational skills in a cross-functional environment. 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 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

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:  

Possess a strong knowledge of basic analytical concepts (concentration units, pH, calibration curves, QCs, compliance, etc.) and basic analytical laboratory operational skills (pipettes, balances, computer skills), etc. Demonstrate the ability to work in a methodical and organized fashion. Understand and follow written methods and documentation best practices to clearly and concisely record laboratory work and equipment maintenance. Have a working knowledge of LC-MS/MS. Exhibita basic understanding of laboratory instrumentation and notebook keeping. Demonstrate a working knowledge of GLPs and general laboratory practices. Possessexcellent communication and organizational skills in a cross-functional environment. 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 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

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: Senior Scientist - Lab Operations and LC-MS/MS Study Support - (Job Number: 178258)