Senior Research Scientist - Project Manager - Genetics / Histology / Pathology

Submission for the position: Senior Research Scientist - Project Manager - Genetics / Histology / Pathology - (Job Number: 171664)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.

In this position for a technology operations lead you will work closely with our IO/CT (immuno-oncology/cell therapy) team to coordinate and track assay development, transfer and validation, including sample analysis, in order to support the client's industry leading Immuno-Oncology (IO) pipeline. The successful candidate will be responsible for ensuring timely delivery of project goals from various types of technologies, such as genomics, flow cytometry, LC/MS, ligand binding assays, IHC and pathology. The tech ops role will include end-to-end oversight from project initiation through data delivery, analysis and report documentation. The successful candidate should have proven work experience in one or more of the technologies (genomics, flow cytometry, LC/MS, ligand-binding assays, IHC, pathology). Prior experience managing work at multiple third party vendors or central labs to support clinical data generation is desired. This is a highly matrixed position and relies on strong organization expertise and robust soft skills. This position will require travel (1x per quarter- west coast) and ability to work remotely/independently.

Primary Role

•Establishes and maintains operating mechanism to facilitate the cohesive and uniform transparency across many projects and external partners

•Coordinate internal resources and third parties/vendors for the flawless execution of projects and BoW clinical and pre-clinical activities for his/her TRC (thematic research center- IO/CT); Ensures success of assays transitioning from TRC into Translational Sciences area

•Ensure that projects are delivered on-time, within scope (and within budget, if needed)

•Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility

•Develop a detailed project plan to monitor and track progress

•Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques

•Contracting monitoring from initiation to ensure execution and delivery

•Measure project performance using appropriate tools and techniques

•Report and escalate to management as needed

•Successfully manage the relationship with the client and all stakeholders through robust communication and stakeholder management

•Perform risk management to minimize project risks; facilitate the transparency of risks and progress for their technology team to key stakeholders and team members

•Establish and maintain relationships with third parties/vendors

•Create and maintain comprehensive project documentation

•Engages in specialty projects to drive Client's success of biomarker activities.

•Interacts with key scientific and operational leaders in single or multiple therapeutic areas.

•Takes lead in management and triage of critical, “systemic”, issues and conflict resolution. Involves key internal players to ensure speedy decision-making process.

•Partners with clinical teams, vendor management, outsourcing management and global procurement, as needed, to drive the strategic Client position to enhance the value of biomarker vendors’ capabilities to the client through early engagement with internal teams as well as our internal partners, cross-organizational discourse and planning transparency.

Grow your career within the scientific ladder, pursue project management, or develop into a leader. These are just a few career pathways available once you become a part of the PPD team.

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! If you feel your skills are a fit for this position - apply now!

PPDFSP

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.

In this position for a technology operations lead you will work closely with our IO/CT (immuno-oncology/cell therapy) team to coordinate and track assay development, transfer and validation, including sample analysis, in order to support the client's industry leading Immuno-Oncology (IO) pipeline. The successful candidate will be responsible for ensuring timely delivery of project goals from various types of technologies, such as genomics, flow cytometry, LC/MS, ligand binding assays, IHC and pathology. The tech ops role will include end-to-end oversight from project initiation through data delivery, analysis and report documentation. The successful candidate should have proven work experience in one or more of the technologies (genomics, flow cytometry, LC/MS, ligand-binding assays, IHC, pathology). Prior experience managing work at multiple third party vendors or central labs to support clinical data generation is desired. This is a highly matrixed position and relies on strong organization expertise and robust soft skills. This position will require travel (1x per quarter- west coast) and ability to work remotely/independently.

Primary Role

•Establishes and maintains operating mechanism to facilitate the cohesive and uniform transparency across many projects and external partners

•Coordinate internal resources and third parties/vendors for the flawless execution of projects and BoW clinical and pre-clinical activities for his/her TRC (thematic research center- IO/CT); Ensures success of assays transitioning from TRC into Translational Sciences area

•Ensure that projects are delivered on-time, within scope (and within budget, if needed)

•Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility

•Develop a detailed project plan to monitor and track progress

•Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques

•Contracting monitoring from initiation to ensure execution and delivery

•Measure project performance using appropriate tools and techniques

•Report and escalate to management as needed

•Successfully manage the relationship with the client and all stakeholders through robust communication and stakeholder management

•Perform risk management to minimize project risks; facilitate the transparency of risks and progress for their technology team to key stakeholders and team members

•Establish and maintain relationships with third parties/vendors

•Create and maintain comprehensive project documentation

•Engages in specialty projects to drive Client's success of biomarker activities.

•Interacts with key scientific and operational leaders in single or multiple therapeutic areas.

•Takes lead in management and triage of critical, “systemic”, issues and conflict resolution. Involves key internal players to ensure speedy decision-making process.

•Partners with clinical teams, vendor management, outsourcing management and global procurement, as needed, to drive the strategic Client position to enhance the value of biomarker vendors’ capabilities to the client through early engagement with internal teams as well as our internal partners, cross-organizational discourse and planning transparency.

Grow your career within the scientific ladder, pursue project management, or develop into a leader. These are just a few career pathways available once you become a part of the PPD team.

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! If you feel your skills are a fit for this position - apply now!

PPDFSP

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:  

Effective written and oral communication skills as well as presentation skills Significant exposure to biomarkers, Pharmacokinetics or immunogenicity operations required, including collections and logistics considerations. Understanding of clinical data and management required.Broad knowledge of genetics/genomics, IHC, flow cytometry, LC/MS, pathology related to assays, platforms and analysis with deeper expertise in at least one technology platform.

Demonstrated strong project management and ability to drive multiple projects of significant complexity/global scope, in a highly virtualized team environment.

Demonstrated ability to analyze and interpret complex problems/data from a variety of sources, and through effective decision-making and planning, deliver superior business results.

Experience in leading organizational/cultural change and managing expectations and risks

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.  

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

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:  

Effective written and oral communication skills as well as presentation skills Significant exposure to biomarkers, Pharmacokinetics or immunogenicity operations required, including collections and logistics considerations. Understanding of clinical data and management required.Broad knowledge of genetics/genomics, IHC, flow cytometry, LC/MS, pathology related to assays, platforms and analysis with deeper expertise in at least one technology platform.

Demonstrated strong project management and ability to drive multiple projects of significant complexity/global scope, in a highly virtualized team environment.

Demonstrated ability to analyze and interpret complex problems/data from a variety of sources, and through effective decision-making and planning, deliver superior business results.

Experience in leading organizational/cultural change and managing expectations and risks

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.  

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

Submission for the position: Senior Research Scientist - Project Manager - Genetics / Histology / Pathology - (Job Number: 171664)