GxP Program Manager
Aequor Technologies LLC | Cambridge | www.resume-library.com |
Job Title: Sr. Project Manager
Skills: GxP experience, Lab experience and active PMP.
Remote (Local to Cambridge, MA for occasional visit), 37.5 Hours per week
BioMedical Research (BR) is the global pharmaceutical research organization of Client. With approximately 6,000 scientists and physicians around the world, our research is focused on discovering innovative new drugs that will change the practice of medicine.
We have an open and entrepreneurial culture, encouraging collaboration to make effective therapies.
At BR, our mission is to Client innovative medicines that treat disease and human health. To do that, our scientists need cutting-edge, state-of-the-art computing systems.
With Research Informatics (RX), BR is making a strategic investment into informatics capabilities and is positioning itself to deliver the systems and services that are critical to the future of drug discovery.
Project Role & Project Description:
Note: This is a primarily remote position with occasional onsite collaboration in Cambridge, MA. Candidates should be based in New England, commutable to Cambridge when necessary.
The purpose of the GxP Program Manager role is to manage a highly complex GxP project within the Research Informatics (RX) function within the Biomedical Research (BR) division of Client Pharmaceuticals. Because of the complexity of the project, including the GxP components, two global locations/time zones, and its criticality to Biomedical Research, it will be managed as a program.
The program is called Program Bridge = Bioanalytical Revamp for Improved Deliverables with Greater Efficiency.
The purpose of this program is to build two regulated bioanalytical labs to enable clinical PK/PD/IG deliverables. This will involve re-internalizing certain GCP deliverables and refreshing the clinical biologics bioanalytical outsourcing model for greater efficiencies within BR.
The program will consist of four major workstreams to deliver the above outcomes.
Only Program Manager-level candidates meeting all of the experience, education and qualification requirements below will be considered.
Major Accountabilities:
Lead the global RX Program Team to deliver program outcomes in each of its workstreams and phases, managing all project and program management aspects in each phase
Manage global cross-functional managerial, business and technical teams through successful program delivery, on time and within budget, and at the quality level required
Proactively manage the program's risks and issues, resolving each promptly and fully to limit impact on progress and escalating as necessary
Facilitate collaborative decision making and issue resolution
Ensure full compliance with GxP requirements for all relevant areas of the program
Ensure adherence to Client global Information Security and Quality standards and policies for all products/services.
Ensure Regulatory Compliance (e.g. GLP & GCP) standards and policies for GxP products/services.
Experience Requirements (Core Skills and Capabilities):
Experience successfully managing bioanalytical labs projects or equivalent
8+ years of experience in a GxP project delivery role accountable for business outcomes
Demonstrated ability to effectively manage a global program/project team of technical, scientific and business associates
Demonstrated success implementing global IT solutions, platforms and infrastructure supporting GxP scientific processes and decision making in a pharmaceutical research or biotech environment
Strong track record of successful delivery of programs/projects in a highly complex global environment
Effective use of agile and adaptive project/program management approaches
Education and Qualification Requirements:
University Degree
Project Management Professional (PMP) or Program Management Professional (PgMP) required; Certified Scrum Master (CSM) certification preferred in addition
8+ years of GxP expertise
Demonstrated success leading GxP laboratory buildouts and operations projects
Language Requirements:
English fluent, German helpful
Skills: GxP experience, Lab experience and active PMP.
Remote (Local to Cambridge, MA for occasional visit), 37.5 Hours per week
BioMedical Research (BR) is the global pharmaceutical research organization of Client. With approximately 6,000 scientists and physicians around the world, our research is focused on discovering innovative new drugs that will change the practice of medicine.
We have an open and entrepreneurial culture, encouraging collaboration to make effective therapies.
At BR, our mission is to Client innovative medicines that treat disease and human health. To do that, our scientists need cutting-edge, state-of-the-art computing systems.
With Research Informatics (RX), BR is making a strategic investment into informatics capabilities and is positioning itself to deliver the systems and services that are critical to the future of drug discovery.
Project Role & Project Description:
Note: This is a primarily remote position with occasional onsite collaboration in Cambridge, MA. Candidates should be based in New England, commutable to Cambridge when necessary.
The purpose of the GxP Program Manager role is to manage a highly complex GxP project within the Research Informatics (RX) function within the Biomedical Research (BR) division of Client Pharmaceuticals. Because of the complexity of the project, including the GxP components, two global locations/time zones, and its criticality to Biomedical Research, it will be managed as a program.
The program is called Program Bridge = Bioanalytical Revamp for Improved Deliverables with Greater Efficiency.
The purpose of this program is to build two regulated bioanalytical labs to enable clinical PK/PD/IG deliverables. This will involve re-internalizing certain GCP deliverables and refreshing the clinical biologics bioanalytical outsourcing model for greater efficiencies within BR.
The program will consist of four major workstreams to deliver the above outcomes.
Only Program Manager-level candidates meeting all of the experience, education and qualification requirements below will be considered.
Major Accountabilities:
Lead the global RX Program Team to deliver program outcomes in each of its workstreams and phases, managing all project and program management aspects in each phase
Manage global cross-functional managerial, business and technical teams through successful program delivery, on time and within budget, and at the quality level required
Proactively manage the program's risks and issues, resolving each promptly and fully to limit impact on progress and escalating as necessary
Facilitate collaborative decision making and issue resolution
Ensure full compliance with GxP requirements for all relevant areas of the program
Ensure adherence to Client global Information Security and Quality standards and policies for all products/services.
Ensure Regulatory Compliance (e.g. GLP & GCP) standards and policies for GxP products/services.
Experience Requirements (Core Skills and Capabilities):
Experience successfully managing bioanalytical labs projects or equivalent
8+ years of experience in a GxP project delivery role accountable for business outcomes
Demonstrated ability to effectively manage a global program/project team of technical, scientific and business associates
Demonstrated success implementing global IT solutions, platforms and infrastructure supporting GxP scientific processes and decision making in a pharmaceutical research or biotech environment
Strong track record of successful delivery of programs/projects in a highly complex global environment
Effective use of agile and adaptive project/program management approaches
Education and Qualification Requirements:
University Degree
Project Management Professional (PMP) or Program Management Professional (PgMP) required; Certified Scrum Master (CSM) certification preferred in addition
8+ years of GxP expertise
Demonstrated success leading GxP laboratory buildouts and operations projects
Language Requirements:
English fluent, German helpful
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