Associate Research Scientist / Research Scientist - ( 6+ years ) - PCR, ELISA, Method Development , GMP

Submission for the position: Associate Research Scientist / Research Scientist - ( 6 years ) - PCR, ELISA, Method Development , GMP - (Job Number: 173897)Associate Research Scientist / Research Scientist - ( 6 years ) - PCR, ELISA, Method Development , GMPAssociate Research Scientist / Research Scientist - ( 6 years ) - PCR, ELISA, Method Development , GMP

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 anAssociate Research Scientist, you will provide support to the Analytical Development team. You will execute large molecule cell-based assays, analytical method development and validation for protein drug substance and protein drug product while working onsite at a major pharmaceutical client lab facility.

Additional Responsibilities while work onsite at a major pharmaceutical customer site:Developing and validating cell based assay, PCR, ELISA, and bioassay methods as per ICH and GMP guidelinesDevelop new chemical assays; write method validation protocols and reportsAbility to identify and solve complex technical issues that correspond to atypical or out-of-specification/trend test results as well as instrumentation and methodology related issues.Write and disseminate technical data summaries and reportsDirect and foster training of scientific associatesRoutine work involvement and weekly meetings with laboratory team to review progress, work through issues and bring resolution to problems, and communicate to laboratory management and coordinate with other technical leaders for assistance and closeout of work activitiesDesign experimental plans to address specific program issuesInterpret, analyze, and manage dataTroubleshoot technical problemsPresent plans and data to key stakeholders and management

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!

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 anAssociate Research Scientist, you will provide support to the Analytical Development team. You will execute large molecule cell-based assays, analytical method development and validation for protein drug substance and protein drug product while working onsite at a major pharmaceutical client lab facility.

Additional Responsibilities while work onsite at a major pharmaceutical customer site:Developing and validating cell based assay, PCR, ELISA, and bioassay methods as per ICH and GMP guidelinesDevelop new chemical assays; write method validation protocols and reportsAbility to identify and solve complex technical issues that correspond to atypical or out-of-specification/trend test results as well as instrumentation and methodology related issues.Write and disseminate technical data summaries and reportsDirect and foster training of scientific associatesRoutine work involvement and weekly meetings with laboratory team to review progress, work through issues and bring resolution to problems, and communicate to laboratory management and coordinate with other technical leaders for assistance and closeout of work activitiesDesign experimental plans to address specific program issuesInterpret, analyze, and manage dataTroubleshoot technical problemsPresent plans and data to key stakeholders and management

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!

Education and Experience:

Bachelor's degree in Analytical Chemistry, Biochemistry, Chemistry, Molecular Biology, or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable 6 years) or equivalent combination of education, training, & experience.Preferred Experience:

Master's degree or Ph.D. in Analytical Chemistry, Biochemistry, Chemistry, Molecular Biology, or equivalent and relevant formal academic / vocational qualification with 4 years of industry experiencePrevious industry experience performing cell based method development and validation in GMP environment per ICH guidelinesKnowledge, Skills and Abilities:

Knowledge of Bio-Pharmaceutical Sciences and DevelopmentAbility to perform cell based method development and validation, ELISA, PCR, bioassayGMP method development and method validation requiredKnowledge of statistical analysis for Analytical ChemistryAbility to independently perform root cause analysis for method investigationsKnowledge of cGMPs, ICH guidelines and Compendia requirementsProficiency on technical operating systems, ELN, Empower, Chemstation a plusProven problem solving and troubleshooting abilitiesProven ability in technical writing skillsTime management and project management skillsGood written and oral communication skillsAbility to work in a collaborative work environment with a teamAbility to train junior staffWorking 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 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 environmentsAble 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.  

GMP , "method development" , "method validation" , bioanalytical , PCR, ELISA , "cell-based" , "large molecule" , bioassay, protein

*LI-NWEducation and Experience:

Bachelor's degree in Analytical Chemistry, Biochemistry, Chemistry, Molecular Biology, or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable 6 years) or equivalent combination of education, training, & experience.Preferred Experience:

Master's degree or Ph.D. in Analytical Chemistry, Biochemistry, Chemistry, Molecular Biology, or equivalent and relevant formal academic / vocational qualification with 4 years of industry experiencePrevious industry experience performing cell based method development and validation in GMP environment per ICH guidelinesKnowledge, Skills and Abilities:

Knowledge of Bio-Pharmaceutical Sciences and DevelopmentAbility to perform cell based method development and validation, ELISA, PCR, bioassayGMP method development and method validation requiredKnowledge of statistical analysis for Analytical ChemistryAbility to independently perform root cause analysis for method investigationsKnowledge of cGMPs, ICH guidelines and Compendia requirementsProficiency on technical operating systems, ELN, Empower, Chemstation a plusProven problem solving and troubleshooting abilitiesProven ability in technical writing skillsTime management and project management skillsGood written and oral communication skillsAbility to work in a collaborative work environment with a teamAbility to train junior staffWorking 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 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 environmentsAble 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.  

GMP , "method development" , "method validation" , bioanalytical , PCR, ELISA , "cell-based" , "large molecule" , bioassay, protein

*LI-NWSubmission for the position: Associate Research Scientist / Research Scientist - ( 6 years ) - PCR, ELISA, Method Development , GMP - (Job Number: 173897)Associate Research Scientist / Research Scientist - ( 6 years ) - PCR, ELISA, Method Development , GMP