Sr Scientist - LC/MS and ELISA Intrument Maintenance Documentation

Submission for the position: Sr Scientist - LC/MS and ELISA Intrument Maintenance Documentation - (Job Number: 171722)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.

Responsibilities for this position include:

Perform routine maintenance for non-data generating instruments (plate washers, water purification systems) per department SOPs.

Coordinate/schedule services (routine or corrective) and calibrations for all instruments (Cat 1 instruments and non-Cat 1) under the supervision of SMEs or instrument owners for data generating instruments (excluding the LC/MS fleet) and manage vendor training and logistics.

Manage vendor servicing contracts and instruments covered by Unity agreement as needed in yearly review. Arrange for new lab instrumentation to be covered by Unity, which involves obtaining quotes, generating POs and managing service.

Support department purchasing by placing orders and resolving issues (broad support). Possibly coordinating capital requests for NDB department which would include scheduling installation with facilities and managing the vendor logistics.

Serve as the Maximo, Category 1 equipment management system, administrator for NDB.

Assist with QC, document system admin duties, and other functions within the Study Support and Compliance group on an as needed basis.

Schedule lab inspections as the SAFE-EVAL system administrator and remediate observations if needed.

Schedule routine cleaning of the labs (e.g. mopping the lab floors and 2x a year rebuffing/wax the floors).

PPD offers continued career advancement on the Scientist track, as well as management and specialized opportunities in other departments within PPD.

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.

To learn how PPD can advance your career, apply now!

What To Expect Next

We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

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.

Responsibilities for this position include:

Perform routine maintenance for non-data generating instruments (plate washers, water purification systems) per department SOPs.

Coordinate/schedule services (routine or corrective) and calibrations for all instruments (Cat 1 instruments and non-Cat 1) under the supervision of SMEs or instrument owners for data generating instruments (excluding the LC/MS fleet) and manage vendor training and logistics.

Manage vendor servicing contracts and instruments covered by Unity agreement as needed in yearly review. Arrange for new lab instrumentation to be covered by Unity, which involves obtaining quotes, generating POs and managing service.

Support department purchasing by placing orders and resolving issues (broad support). Possibly coordinating capital requests for NDB department which would include scheduling installation with facilities and managing the vendor logistics.

Serve as the Maximo, Category 1 equipment management system, administrator for NDB.

Assist with QC, document system admin duties, and other functions within the Study Support and Compliance group on an as needed basis.

Schedule lab inspections as the SAFE-EVAL system administrator and remediate observations if needed.

Schedule routine cleaning of the labs (e.g. mopping the lab floors and 2x a year rebuffing/wax the floors).

PPD offers continued career advancement on the Scientist track, as well as management and specialized opportunities in other departments within PPD.

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.

To learn how PPD can advance your career, apply now!

What To Expect Next

We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

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)

Knowledge, Skills and Abilities: Understanding of analytical instrumentation such as 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, TOCSolid understanding and knowledge of general chemistry and separation scienceAt least one year of experience in a regulated Lab industry environment such as GMP or GLP.

Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidanceAbility to utilize Microsoft Excel and Work to perform tasksMaintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOPProficiency on technical operating systemsProven problem solving and troubleshooting abilitiesEffective oral and written communication skillsProven ability in technical writing skillsTime management and project management skillsAbility to work in a collaborative work environment with a teamProven problem solving and troubleshooting abilitiesAbility to train junior staff

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 mannerAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 poundsAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay 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 activitiesRegular and consistent attendanceELISA, LC-MS, Immunoassay, bioanalytical, GxP (GLP or GMP), Instrument Maintenance, QC, Audit, 21 CFR

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)

Knowledge, Skills and Abilities: Understanding of analytical instrumentation such as 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, TOCSolid understanding and knowledge of general chemistry and separation scienceAt least one year of experience in a regulated Lab industry environment such as GMP or GLP.

Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidanceAbility to utilize Microsoft Excel and Work to perform tasksMaintain a laboratory notebook and complete all documentation with clear and accurate language and according to the SOPProficiency on technical operating systemsProven problem solving and troubleshooting abilitiesEffective oral and written communication skillsProven ability in technical writing skillsTime management and project management skillsAbility to work in a collaborative work environment with a teamProven problem solving and troubleshooting abilitiesAbility to train junior staff

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 mannerAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 poundsAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay 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 activitiesRegular and consistent attendanceELISA, LC-MS, Immunoassay, bioanalytical, GxP (GLP or GMP), Instrument Maintenance, QC, Audit, 21 CFR

Submission for the position: Sr Scientist - LC/MS and ELISA Intrument Maintenance Documentation - (Job Number: 171722)