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Senior Scientist - Project Manager - Biopharm

Pharmaceutical Product Development (PPD)

NJ-Princeton-FSP Lawrenceville NJ

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.

In this position you will work closely with our client's Pharmacodiagnostics (PDx) team to coordinate and track assay development/validation and clinical trial sample analysis, in order to support the client's large diagnostic pipeline. You 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 PDx Tech Ops role will include end-to-end oversight or project initiated by PDx scientists, from contracting through data delivery, analysis and report documentation. You 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 third party vendors or central labs to support PDx data generation along with exposure to regulatory requirements is desired. This is a highly matrixed position and relies on strong organization expertise and robust soft skills. This position will require the ability to work remotely/independently.

Primary Job Responsibilities:

Successfully manage and support the relationship with the PDx team and stakeholdersParticipate directly on the PDx functional team in a matrix role to ensure close connectivity and awareness of critical activities and priorities for the organizationDevelop operating models and processes as needed to ensure effective engagement with PDx vendors and alignment with broader PDx planning/logisticsFunction as the single point of contact between the PDx scientists and the Client Biorepository for sample management related to PDx development programsManage all operations for non-clinical/bridging studies under scientific oversight of the PDx teamInteract with key scientific and operational leaders in single or multiple therapeutic areasEnsure efficient operational coordination across multiple internal functions, including related project management teams, clinical teams, vendor management, outsourcing management, global procurement, biomarker leads, biomarker and sample operations, as needed, to enhance the value of vendors’ capabilities to the Client through early engagement with internal teams and partners, cross-organizational discourse and planning transparencyCoordinate subject matter expert data reviews for biomarker endpoints under the oversight of the PDx team (ensure proper assignment of activities and coordination of timelines to meet clinical database locks)Ensure effective management of vendor queries related to PDx partners; identify trends and develop operational improvements to eliminate systemic issuesOversee sample quality with biomarker leads and clinical operations (ensure PDx-specific input into sample collection & lab manual to allow for proper sample treatment, and to ensure sample retention for bridging/validation activities where needed)Manage and coordinate diagnostic kit forecasts for the clinical portfolio (e.g. PDL1 kit forecasts) Maintain internal workflow and project tracking system (TeMPO) for all PDx assay development, validation & sample analysis requests; develop PDx Projects in TeMPO as needed for additional project types to ensure complete capture of PDx Book of Work.Review statements of work (contracts) with new vendors to ensure operational feasibility and assist in on-boarding vendorsParticipate in quality audits related to samples and coordinate CAPA responses, if neededEstablishes 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 activitiesEstablish and maintain relationships with third parties/vendorsMaintain list of approved vendors/validations/indications/usesFunction as liaison between PDx team, training vendor, and scoring vendor for IHC/pathology workAssist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility

Ensure that projects are delivered on-time, within scope Develop a detailed project plan to monitor and track progressManage changes to the project scope, project schedule, and project costs using appropriate verification techniquesMeasure project performance using appropriate tools and techniquesCreate and maintain comprehensive project documentationPerform risk management to minimize project risks; facilitate the transparency of risks and progress for their technology team to key stakeholders and team membersMaintain documentation in TMF (trial master file)Report to PDx Head on established frequency regarding project status, issues, and risks.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

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.

In this position you will work closely with our client's Pharmacodiagnostics (PDx) team to coordinate and track assay development/validation and clinical trial sample analysis, in order to support the client's large diagnostic pipeline. You 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 PDx Tech Ops role will include end-to-end oversight or project initiated by PDx scientists, from contracting through data delivery, analysis and report documentation. You 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 third party vendors or central labs to support PDx data generation along with exposure to regulatory requirements is desired. This is a highly matrixed position and relies on strong organization expertise and robust soft skills. This position will require the ability to work remotely/independently.

Primary Job Responsibilities:

Successfully manage and support the relationship with the PDx team and stakeholdersParticipate directly on the PDx functional team in a matrix role to ensure close connectivity and awareness of critical activities and priorities for the organizationDevelop operating models and processes as needed to ensure effective engagement with PDx vendors and alignment with broader PDx planning/logisticsFunction as the single point of contact between the PDx scientists and the Client Biorepository for sample management related to PDx development programsManage all operations for non-clinical/bridging studies under scientific oversight of the PDx teamInteract with key scientific and operational leaders in single or multiple therapeutic areasEnsure efficient operational coordination across multiple internal functions, including related project management teams, clinical teams, vendor management, outsourcing management, global procurement, biomarker leads, biomarker and sample operations, as needed, to enhance the value of vendors’ capabilities to the Client through early engagement with internal teams and partners, cross-organizational discourse and planning transparencyCoordinate subject matter expert data reviews for biomarker endpoints under the oversight of the PDx team (ensure proper assignment of activities and coordination of timelines to meet clinical database locks)Ensure effective management of vendor queries related to PDx partners; identify trends and develop operational improvements to eliminate systemic issuesOversee sample quality with biomarker leads and clinical operations (ensure PDx-specific input into sample collection & lab manual to allow for proper sample treatment, and to ensure sample retention for bridging/validation activities where needed)Manage and coordinate diagnostic kit forecasts for the clinical portfolio (e.g. PDL1 kit forecasts) Maintain internal workflow and project tracking system (TeMPO) for all PDx assay development, validation & sample analysis requests; develop PDx Projects in TeMPO as needed for additional project types to ensure complete capture of PDx Book of Work.Review statements of work (contracts) with new vendors to ensure operational feasibility and assist in on-boarding vendorsParticipate in quality audits related to samples and coordinate CAPA responses, if neededEstablishes 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 activitiesEstablish and maintain relationships with third parties/vendorsMaintain list of approved vendors/validations/indications/usesFunction as liaison between PDx team, training vendor, and scoring vendor for IHC/pathology workAssist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility

Ensure that projects are delivered on-time, within scope Develop a detailed project plan to monitor and track progressManage changes to the project scope, project schedule, and project costs using appropriate verification techniquesMeasure project performance using appropriate tools and techniquesCreate and maintain comprehensive project documentationPerform risk management to minimize project risks; facilitate the transparency of risks and progress for their technology team to key stakeholders and team membersMaintain documentation in TMF (trial master file)Report to PDx Head on established frequency regarding project status, issues, and risks.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

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 4 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:  

Significant exposure to biomarkers, Pharmacokinetics or immunogenicity operations required, including collections and logistics considerations.At least 2 years of Pharmaceutical or CRO experience is required.Understanding of clinical data and management required.Firsthand knowledge of laboratory operations highly desired.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 skills 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.

Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance Full knowledge of technical operating systems Proven technical writing skillsProven problem solving and troubleshooting abilities Effective written and oral communication skills as well as presentation skills Time management and project management skills Ability to mentor others on technical operating systems Ability to independently review and understand project proposals/plans Ability to work in a collaborative work environment with a team 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. 

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 4 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:  

Significant exposure to biomarkers, Pharmacokinetics or immunogenicity operations required, including collections and logistics considerations.At least 2 years of Pharmaceutical or CRO experience is required.Understanding of clinical data and management required.Firsthand knowledge of laboratory operations highly desired.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 skills 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.

Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance Full knowledge of technical operating systems Proven technical writing skillsProven problem solving and troubleshooting abilities Effective written and oral communication skills as well as presentation skills Time management and project management skills Ability to mentor others on technical operating systems Ability to independently review and understand project proposals/plans Ability to work in a collaborative work environment with a team 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. 

Job posted: 2020-07-22

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