QC Scientist - FTIR , ELISA , Raw Materials , GMP

Submission for the position: QC Scientist - FTIR , ELISA , Raw Materials , GMP - (Job Number: 183151)

In labs and health care facilities worldwide- HERE WE ARE

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.

As a Scientist,you will join the Cell and Gene TherapyDepartment to perform QC testing in a fast-paced GMP environment. You will betesting incoming raw materials for appearance and identity, which will be a significant aspect of the position. You will be performing various tests such as: FTIR, flow cytometry, ELISA, etc..

Additional key responsibilities for the role on site at a major pharmaceutical company: Perform QC testing on raw materials using FTIR, Flow Cytometry, ELISA Perform a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications Enters data into databases and reports. Performsself-reviewfor own data prior to QC submission. Sets up and maintains instrumentation Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems. Communicates project status to project leader. Performs work assignments accurately, and in a timely and safe manner. Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

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.

Join PPD in our relentless pursuit of excellence - apply now!

In labs and health care facilities worldwide- HERE WE ARE

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.

As a Scientist,you will join the Cell and Gene TherapyDepartment to perform QC testing in a fast-paced GMP environment. You will betesting incoming raw materials for appearance and identity, which will be a significant aspect of the position. You will be performing various tests such as: FTIR, flow cytometry, ELISA, etc..

Additional key responsibilities for the role on site at a major pharmaceutical company: Perform QC testing on raw materials using FTIR, Flow Cytometry, ELISA Perform a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications Enters data into databases and reports. Performsself-reviewfor own data prior to QC submission. Sets up and maintains instrumentation Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems. Communicates project status to project leader. Performs work assignments accurately, and in a timely and safe manner. Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

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.

Join PPD in our relentless pursuit of excellence - apply now!

Education and Experience:  Bachelor's degree in biological science or chemistryor equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years industry experience).

Preferred Experience: 2 years of GMP QC testing experience required Raw material testing experience preferred Previously worked in a raw materials control lab strongly preferred Previous experience working with FTIR reference standards, selecting and sourcing them preferred Hands-on experience with FTIR, Flow Cytometry,BacT/Alert, endosafe, and mycoplasma Q-PCR Experience with investigations, including OOS,Environmental monitoring as well as safety testing experience (sterility, endotoxin, mycoplasma) is a plus

In somecases,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: Demonstrated knowledge of multiple applicable techniques such as: FTIR, Flow Cytometry, ELISA, BacT/Alert, endosafe, and mycoplasma qPCR Knowledge of applicable regulatory authority, compendia and ICH guidelines Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use Proficient in Microsoft Excel and Word Proven ability to interpret data by performing trend analysis Proven ability in technical writing skills Ability to independently optimize analytical methods Proven problem solving and troubleshooting abilities Good written and oral communication 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 well being 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.    

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. 

keywords: GMP, QC, "quality control" , "reference standards" ,FTIR,instrument IO/OQ,SOPs, "assay qualification", "raw materials testing" , "raw materials" , ELISA , "flow cytometry"

PPDFSP

*LI-NW1

Education and Experience:  Bachelor's degree in biological science or chemistryor equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years industry experience).

Preferred Experience: 2 years of GMP QC testing experience required Raw material testing experience preferred Previously worked in a raw materials control lab strongly preferred Previous experience working with FTIR reference standards, selecting and sourcing them preferred Hands-on experience with FTIR, Flow Cytometry,BacT/Alert, endosafe, and mycoplasma Q-PCR Experience with investigations, including OOS,Environmental monitoring as well as safety testing experience (sterility, endotoxin, mycoplasma) is a plus

In somecases,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: Demonstrated knowledge of multiple applicable techniques such as: FTIR, Flow Cytometry, ELISA, BacT/Alert, endosafe, and mycoplasma qPCR Knowledge of applicable regulatory authority, compendia and ICH guidelines Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use Proficient in Microsoft Excel and Word Proven ability to interpret data by performing trend analysis Proven ability in technical writing skills Ability to independently optimize analytical methods Proven problem solving and troubleshooting abilities Good written and oral communication 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 well being 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.    

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. 

keywords: GMP, QC, "quality control" , "reference standards" ,FTIR,instrument IO/OQ,SOPs, "assay qualification", "raw materials testing" , "raw materials" , ELISA , "flow cytometry"

PPDFSP

*LI-NW1 Submission for the position: QC Scientist - FTIR , ELISA , Raw Materials , GMP - (Job Number: 183151)