Senior Research Scientist - qPCR Cell and Gene Therapy

Submission for the position: Senior Research Scientist - qPCR Cell and Gene Therapy - (Job Number: 179420)

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.

As a Senior Research Scientist in this position youwill have suitable skill set and knowledge in molecular biology and analytical assay development and are excited to take on new challenges in a fast-paced and dynamic environment. You will be responsible for development and qualification of analytical methods in support of hematopoietic stem cell gene therapies.

The ideal candidate will also have a strong passion and curiosity for science and gene therapy with the desire to bring needed cures from bench to bedside. Demonstrated genuine interest and curiosity in research and analytical development is highly valued.

Youwill have experience in multiple different genotyping and gene expression analysis approaches including, but not

limited to, Taqman-based, standard dideoxy-sequencing, microarray and NGS-based genotyping and gene expression

assays. Previous hand on experience with handling human DNA and RNA, working with and troubleshooting robotic

instruments such as Tecan and Perkin-Elmer, Applied Biosystems, Affymetrix and Illumina (7900, Viia7, Quant-Studio,

MiSeq, NextSeq) software is strongly preferred. Knowledge and hand-on experience of high throughput quantitative RTPCR is desired.

You will deliver genetics book of work across all therapeutic areas with high quality in a timely manner. Additional

responsibilities include data analysis and interpretation, as well as oral and written presentation of experimental findings.

Candidate will efficiently and independently perform the duties and responsibilities.

You will be able to provide subject matter expertise to specialty contract service providers with standards and preferred

testing processes; will be responsible for project coordination with appropriate stakeholders and CRO service provider,

will facilitate meetings with project team and clinical genetics/genomics group. A successful candidate will demonstrate

understanding of the Client matrix relationship environment to build and maintain a formal and informal network of key

individuals.

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

PPDFSP

*LI-SW1

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.

As a Senior Research Scientist in this position youwill have suitable skill set and knowledge in molecular biology and analytical assay development and are excited to take on new challenges in a fast-paced and dynamic environment. You will be responsible for development and qualification of analytical methods in support of hematopoietic stem cell gene therapies.

The ideal candidate will also have a strong passion and curiosity for science and gene therapy with the desire to bring needed cures from bench to bedside. Demonstrated genuine interest and curiosity in research and analytical development is highly valued.

Youwill have experience in multiple different genotyping and gene expression analysis approaches including, but not

limited to, Taqman-based, standard dideoxy-sequencing, microarray and NGS-based genotyping and gene expression

assays. Previous hand on experience with handling human DNA and RNA, working with and troubleshooting robotic

instruments such as Tecan and Perkin-Elmer, Applied Biosystems, Affymetrix and Illumina (7900, Viia7, Quant-Studio,

MiSeq, NextSeq) software is strongly preferred. Knowledge and hand-on experience of high throughput quantitative RTPCR is desired.

You will deliver genetics book of work across all therapeutic areas with high quality in a timely manner. Additional

responsibilities include data analysis and interpretation, as well as oral and written presentation of experimental findings.

Candidate will efficiently and independently perform the duties and responsibilities.

You will be able to provide subject matter expertise to specialty contract service providers with standards and preferred

testing processes; will be responsible for project coordination with appropriate stakeholders and CRO service provider,

will facilitate meetings with project team and clinical genetics/genomics group. A successful candidate will demonstrate

understanding of the Client matrix relationship environment to build and maintain a formal and informal network of key

individuals.

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

PPDFSP

*LI-SW1

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 10 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:   Extensive experience with molecular biology techniques (primer/probe design, qPCR, RT-PCR) and cell manipulation (transfection and transduction) Hand s-on experience in ELISAs, viral transduction, flow cytometry. Experience qualifying and transferring analytical methods to a QC lab setting Proven track record in method development, including experimental design, execution and evaluation. Experience with GMP and ICH regulations is desired. Ability to work in a fast-paced environment, meet deadlines, and prioritize work on multiple projects. Strong communication skills in technical writing and oral presentation. Ability to carefully follow existing methods and SOPs. Ability to maintain meticulous records and documentation. Strong sense of responsibility, accountability, and integrity. Demonstrated Expert ability in qPCR Proficient with Excel, JMP and DNA analysis software is desired. Experience with droplet digital PCR (ddPCR) is desired. Experience in proteomics is desired. Experience with method validation and tech transfer is desired. Strong time management skills with the capacity to prioritize work from multiple projects to meet deadlines. Ability to independently perform root cause analysis for method investigations Proficiency on technical operating systems Effective written and oral communication skills as well as presentation skills Knowledge and application of industry best practices not yet represented by global regulatory requirements Full theoretical and hands-on understanding and knowledge of general chemistry and separation science Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance Ability to independently review and understand project proposals/plans Proven ability in technical writing skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to independently optimize analytical methods Time management and project management skills

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.   Mayhave exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.  Ableto 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 10 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:   Extensive experience with molecular biology techniques (primer/probe design, qPCR, RT-PCR) and cell manipulation (transfection and transduction) Hand s-on experience in ELISAs, viral transduction, flow cytometry. Experience qualifying and transferring analytical methods to a QC lab setting Proven track record in method development, including experimental design, execution and evaluation. Experience with GMP and ICH regulations is desired. Ability to work in a fast-paced environment, meet deadlines, and prioritize work on multiple projects. Strong communication skills in technical writing and oral presentation. Ability to carefully follow existing methods and SOPs. Ability to maintain meticulous records and documentation. Strong sense of responsibility, accountability, and integrity. Demonstrated Expert ability in qPCR Proficient with Excel, JMP and DNA analysis software is desired. Experience with droplet digital PCR (ddPCR) is desired. Experience in proteomics is desired. Experience with method validation and tech transfer is desired. Strong time management skills with the capacity to prioritize work from multiple projects to meet deadlines. Ability to independently perform root cause analysis for method investigations Proficiency on technical operating systems Effective written and oral communication skills as well as presentation skills Knowledge and application of industry best practices not yet represented by global regulatory requirements Full theoretical and hands-on understanding and knowledge of general chemistry and separation science Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance Ability to independently review and understand project proposals/plans Proven ability in technical writing skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to independently optimize analytical methods Time management and project management skills

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.   Mayhave exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.  Ableto perform successfully under pressure while prioritizing and handling multiple projects or activities. 

Submission for the position: Senior Research Scientist - qPCR Cell and Gene Therapy - (Job Number: 179420)