Clinical Formulation Manager
il y a 2 semaines
Your Profile
">We are seeking a highly motivated and experienced professional to fill the role of Drug Product Expert. The ideal candidate will have a Scientific Master's degree (Ph.D is an asset), fluency in English and French, and significant experience in clinical DP development. You will be responsible for leading functional initiatives and contributing to project strategies that advance Pharma Science's Science & Technology and Innovation projects. Your primary responsibility will be to act as a senior expert in clinical DP development, accountable for leading and running assigned project work packages.
Responsibilities:
- Act as a senior expert in clinical DP development, accountable for leading and running assigned project work packages.
- Contribute to project sub-team (DS, DP or analytical) as senior SME representing own area of expertise and actively contributing to the elaboration of project strategy.
- Drive development (internal or external) of innovative formulations and manufacturing processes for the supply of bulk clinical trial material for development pipeline projects.
- Identify scientifically the best formulation and process for accelerated, standard and enabling clinical formulations by designing, planning, performing, interpreting and reporting results of experiments in time to influence strategic project decisions and recommend next steps.
- Ensure process robustness, validation and transfer of NCEs and Lifecycle management of mature product manufacturing process and technologies to commercial launch site.
- Perform clinical formulation orientation work in collaboration with Non-Clinical Formulation Lead to transition the project from Product Material Orientation (PMO) team to DP dev. team.
- Manage CLO/CRO/CMO activities, including selection, negotiation and implementation of appropriate agreements in cooperation with Outsourcing representative.
- Contribute to setting and delivering departmental goals & priorities.
- Subject matter expert and trusted partner in a specific area of DS, DP or Analytical function working according to appropriate standards for quality (GMP, GSP and GLP), ethics, health, safety, environment, protection and IT; leading functional initiatives to ensure continuous improvement.
- Contribute to DS, DP or Analytical project sub-team to the elaborate project DS, DP or analytical strategies by proactively sharing plans, information, data and conclusions and taking full responsibility for all designated tasks associated with own area of expertise.
- Autonomously coordinate and manage technical activities for assigned work packages internally and/or externally to required quality, timeline and budget eg. DS/DP clinical campaigns, DS & DP process optimization, analytical method development & validation, stability program, route evaluation, form selection, material characterization, ...
- Design experiments/trials and studies in accordance with Operating Model to support projects DS, DP or analytical development in an autonomous manner.
- Evaluate and interpret data with different degree of complexity, draw relevant conclusions; openly collaborate with laboratory technicians and scientists to deliver activities for assigned work package; perform complex tasks without having established procedures.
- Work according to appropriate standards following the principles of Quality by Design (QbD).
- Autonomously write high quality source documents including experiment plans, protocols and reports according to data integrity requirements to enable regulatory filing. Support department with the review of protocols and reports from other SMEs.
- Lead the transfer of know how to other departments or external contractors, including troubleshooting and on-site training.
- Champion the use of the operating model to ensure the right experiments/work packages are executed at the right time fully utilizing the strategy/guideline documents that will be embedded in the operating model. Leading implementation of the 'how of the operating model'.
- Closely collaborate with other SMEs within PS, our client community across functions and organizations to ensure delivery of cross-functional technical activities to quality time and to develop patient centric solutions.
- Support DS, DP or analytical PL with by providing resource and timelines for specific activities
- Uses technical and regulatory knowledge to anticipate HA expectations and identify risks
- Proactively communicate risks and deviations from forecasted plans to DS, DP or analytical PL and sub-team members.
- Take an active role for area of expertise in audits and interactions with Health Authorities and inspection as required.
- Collaborate, support and provide scientific mentoring/coaching for laboratory scientists and less experienced SMEs in execution of experimental work.
- Contribute to departmental goals & priorities in a collaborative manner using knowledge of our client's organizational systems and structures.
- Contributes to setting the sciences and technology strategy direction of the department as it relates to own area of expertise.
- Maintain an up-to-date knowledge of own area of expertise to be recognized as a technical expert within own function and across PS
- To develop proactively creative and efficient solutions for IP protection of Drug Product and manufacturing processes.
- As an expert contribute to scientific publications, present at conferences and represent area of expertise on industry boards and through academic collaborations.
- To develop proactively creative and efficient solutions for IP protection of Drug Product and manufacturing processes.
- Maintain an up-to-date knowledge of own area of expertise to be recognized as a technical expert within own function and across PS
- Contributes to setting the sciences and technology strategy direction of the department as it relates to own area of expertise.
- Contribute to departmental goals & priorities in a collaborative manner using knowledge of our client's organizational systems and structures.
- Collaborate, support and provide scientific mentoring/coaching for laboratory scientists and less experienced SMEs in execution of experimental work.
- Take an active role for area of expertise in audits and interactions with Health Authorities and inspection as required.
- Proactively communicate risks and deviations from forecasted plans to DS, DP or analytical PL and sub-team members.
- Closely collaborate with other SMEs within PS, our client community across functions and organizations to ensure delivery of cross-functional technical activities to quality time and to develop patient centric solutions.
- Champion the use of the operating model to ensure the right experiments/work packages are executed at the right time fully utilizing the strategy/guideline documents that will be embedded in the operating model. Leading implementation of the 'how of the operating model'.
- Lead the transfer of know how to other departments or external contractors, including troubleshooting and on-site training.
- Autonomously write high quality source documents including experiment plans, protocols and reports according to data integrity requirements to enable regulatory filing. Support department with the review of protocols and reports from other SMEs.
- Work according to appropriate standards following the principles of Quality by Design (QbD).
- Evaluate and interpret data with different degree of complexity, draw relevant conclusions; openly collaborate with laboratory technicians and scientists to deliver activities for assigned work package; perform complex tasks without having established procedures.
- Design experiments/trials and studies in accordance with Operating Model to support projects DS, DP or analytical development in an autonomous manner.
- Autonomously coordinate and manage technical activities for assigned work packages internally and/or externally to required quality, timeline and budget eg. DS/DP clinical campaigns, DS & DP process optimization, analytical method development & validation, stability program, route evaluation, form selection, material characterization, ...
- Contribute to DS, DP or Analytical project sub-team to the elaborate project DS, DP or analytical strategies by proactively sharing plans, information, data and conclusions and taking full responsibility for all designated tasks associated with own area of expertise.
- Subject matter expert and trusted partner in a specific area of DS, DP or Analytical function working according to appropriate standards for quality (GMP, GSP and GLP), ethics, health, safety, environment, protection and IT; leading functional initiatives to ensure continuous improvement.
- Contribute to setting and delivering departmental goals & priorities.
- Manage CLO/CRO/CMO activities, including selection, negotiation and implementation of appropriate agreements in cooperation with Outsourcing representative.
- Perform clinical formulation orientation work in collaboration with Non-Clinical Formulation Lead to transition the project from Product Material Orientation (PMO) team to DP dev. team.
- Ensure process robustness, validation and transfer of NCEs and Lifecycle management of mature product manufacturing process and technologies to commercial launch site.
- Identify scientifically the best formulation and process for accelerated, standard and enabling clinical formulations by designing, planning, performing, interpreting and reporting results of experiments in time to influence strategic project decisions and recommend next steps.
- Drive development (internal or external) of innovative formulations and manufacturing processes for the supply of bulk clinical trial material for development pipeline projects.
- Contribute to project sub-team (DS, DP or analytical) as senior SME representing own area of expertise and actively contributing to the elaboration of project strategy.
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