Senior Scientist - Method Development , ELISA , PCR , GMP

Submission for the position: Senior Scientist - Method Development , ELISA , PCR , GMP - (Job Number: 182651)

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 aSeniorScientist, you will provide support to the Analytical Development team. You will enable large molecule drug substance and drug product development from clinical to commercial filing. The position will also be responsible for training junior level scientists. You will perform analytical method development and validation, analytical investigations, support of stability studies for clinical drug substance and drug products.

Primary responsibilities while work onsite at a major pharmaceutical customer site:

Executing analytical method development and validation, analytical investigations, support of stability studies for clinical drug substance and drug product. Extensive knowledge and application of Cell-based assay, ELISA and qPCR. Develop new chemical assays; write method validation protocols and reports Write and disseminate technical data summaries and reports which may be included in regulatory submissions R outine 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 activities Design experimental plans to address specific program issues Interpret, analyze, and manage data Troubleshoot technical problems Ability 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. Internal drive to learn new skills, assist on a wide variety of projects and be adaptable to new areas of development as priorities change within the department. Effectively coordinate and track the progress of multiple Analytical related projects Present plans and data to key stakeholders and management Direct and foster training of junior level scientists.

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 aSeniorScientist, you will provide support to the Analytical Development team. You will enable large molecule drug substance and drug product development from clinical to commercial filing. The position will also be responsible for training junior level scientists. You will perform analytical method development and validation, analytical investigations, support of stability studies for clinical drug substance and drug products.

Primary responsibilities while work onsite at a major pharmaceutical customer site:

Executing analytical method development and validation, analytical investigations, support of stability studies for clinical drug substance and drug product. Extensive knowledge and application of Cell-based assay, ELISA and qPCR. Develop new chemical assays; write method validation protocols and reports Write and disseminate technical data summaries and reports which may be included in regulatory submissions R outine 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 activities Design experimental plans to address specific program issues Interpret, analyze, and manage data Troubleshoot technical problems Ability 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. Internal drive to learn new skills, assist on a wide variety of projects and be adaptable to new areas of development as priorities change within the department. Effectively coordinate and track the progress of multiple Analytical related projects Present plans and data to key stakeholders and management Direct and foster training of junior level scientists.

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 Molecular or Cellular Biology, Biochemistry, or Chemistry, or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4 years) or equivalent combination of education, training, & experience. Master's degree in Molecular or Cellular Biology, Biochemistry, or Chemistry, or equivalent and relevant formal academic / vocational qualification with comparable 2 years industry experience Ph.D. in Molecular or Cellular Biology, Biochemistry, or Chemistry, or equivalent and relevant formal academic / vocational qualification with comparable 0-2 years industry experience

Preferred Experience: Master's degree or Ph.D. in Molecular or Cellular Biology, Biochemistry, or Chemistry, or equivalent and relevant formal academic / vocational qualification with 2 years of industry experience Previous industry experience performing cell-based assay, ELISA, and/or qPCR method development and validation in GMP environment per ICH guidelines

Knowledge, Skills and Abilities: Ability to perform cell-based, enzyme based, and qPCR potency assay required Knowledgeable of advanced Analytical Chemistry (HPLC, SEC-MALS, cIEF, ELISA, SDS-PAGE, etc.) GMP method development and method validation required Knowledge of Bio-Pharmaceutical Sciences and Development Previous experience in cGMPs, ICH guidelines, and Compendia required Ability to independently perform root cause analysis for method investigations Statistical analysis for Analytical Chemistry Proficiency on technical operating systems, ELN, Empower, Chemstation a plus Proven problem solving and troubleshooting abilities Proven ability in technical writing skills Time management and project management skills Good written and oral communication skills Ability to work in a collaborative work environment with a team on Analytical, Formulation, and Process Development experiments A motivated self-starter, creative, innovative thinker, easily adaptable to change, deadline driven, well organized Ability to train junior staff

"method development" , "analytical chemistry" , "large molecules" , ELISA , PCR , "cell-based assay" , "validation" , GMP , "biopharma" , pharmaceutical , "enzyme based assays"

PPDFSP

*LI-NW1

Education and Experience : Bachelor's degree in Molecular or Cellular Biology, Biochemistry, or Chemistry, or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4 years) or equivalent combination of education, training, & experience. Master's degree in Molecular or Cellular Biology, Biochemistry, or Chemistry, or equivalent and relevant formal academic / vocational qualification with comparable 2 years industry experience Ph.D. in Molecular or Cellular Biology, Biochemistry, or Chemistry, or equivalent and relevant formal academic / vocational qualification with comparable 0-2 years industry experience

Preferred Experience: Master's degree or Ph.D. in Molecular or Cellular Biology, Biochemistry, or Chemistry, or equivalent and relevant formal academic / vocational qualification with 2 years of industry experience Previous industry experience performing cell-based assay, ELISA, and/or qPCR method development and validation in GMP environment per ICH guidelines

Knowledge, Skills and Abilities: Ability to perform cell-based, enzyme based, and qPCR potency assay required Knowledgeable of advanced Analytical Chemistry (HPLC, SEC-MALS, cIEF, ELISA, SDS-PAGE, etc.) GMP method development and method validation required Knowledge of Bio-Pharmaceutical Sciences and Development Previous experience in cGMPs, ICH guidelines, and Compendia required Ability to independently perform root cause analysis for method investigations Statistical analysis for Analytical Chemistry Proficiency on technical operating systems, ELN, Empower, Chemstation a plus Proven problem solving and troubleshooting abilities Proven ability in technical writing skills Time management and project management skills Good written and oral communication skills Ability to work in a collaborative work environment with a team on Analytical, Formulation, and Process Development experiments A motivated self-starter, creative, innovative thinker, easily adaptable to change, deadline driven, well organized Ability to train junior staff

"method development" , "analytical chemistry" , "large molecules" , ELISA , PCR , "cell-based assay" , "validation" , GMP , "biopharma" , pharmaceutical , "enzyme based assays"

PPDFSP

*LI-NW1 Submission for the position: Senior Scientist - Method Development , ELISA , PCR , GMP - (Job Number: 182651)