Senior Project Manager for External Manufacturing-00000OPR
Description
Position Title: Senior Project Manager External Manufacturing
Department: Ethicon Biosurgery External Manufacturing
Report to: Program Director External Manufacturing
Location: Europe, Israel.
MD&D Global Biologics is currently recruiting for a Snr. Project Manager – External Manufacturing Operations The position can be located in Europe or Israel
Global Biologics is currently comprised primarily of the Ethicon Biosurgery Business Unit which is a unique business that includes medical devices, biologics and combination device/biologic products. It is comprised of the Omrix business in Israel, the newly acquired BioSeal business in China, the JJWM legacy businesses as well as several strategic external partnerships.
Reporting to the Program Director for External Manufacturing, the Senior Project Manager (SPM) – External Manufacturing will provide project leadership for the technical transfers and establishment of duplicate drug substance biologic manufacturing operations from the Omrix facilities in Israel to a new external manufacturing partner. The partner Octapharma GmbH is based in Vienna Austria. The candidate will establish and help build the cross functional project core teams to deliver the project goals and objectives to meet the business needs.
The candidate will interact and collaborate with the following teams on a regular basis: Omrix Operations Leadership Team, Global Biologics Operations Leadership Team, Franchise Operations Development Team, Quality Operations Leadership Team, Global Surgery Supply Chain Leadership Team, Ethicon Biosurgery sponsors and key stakeholders, Octapharma leadership & key stakeholders, Corporate WWEng. Personnel.
SCOPE & MAIN RESPONSIBILITIES:
The Senior Project Manager (SPM) will lead a diverse internationally based core team and SME’s. The core team members will represent all the major functions within the Omrix and wider Ethicon Biosurgery organizations.
Will work closely with the Octapharma leadership and core team.
• Establishing a close cross company relationship. ensuring that both project teams are aligned:
• A common set of goals and final project objectives with a well defined scope
• Ensure that day to day tracking and progress is maintained at to meet the project timelines
• Management and impact of scope changes
• Ensure all Ethicon Biosurgery requirements are met in the on-going project execution at Octapharma. Clear design requirements and specifications are understood and communicated to establish the new manufacturing facility
• Appropriate project management, design control and design verification process is established between the teams that fit within the established project management procedures and quality systems.
Work closely with the Ethicon Biosurgery core team to ensure
• Those adequate resources are made available by the functional leaders to support the project.
• Define the project priorities and establish clear goals and objectives within each work stream
• Ensure all work stream leaders within the core team are tracking and reporting out progress
• Establish and help facilitate close working relationships between core team members of both teams
• Ensure data transfer and knowledge transfer plans are established and executed to plan
• Establish a project risk management program to ensure all critical risk are identified and mitigated on a continuous basis
• Establish and manage a detailed project budget and report out to the Program Director
The SPM will establish a clear communication plan to ensure that all team members, partners, sponsors and stakeholders are kept informed of progress and where necessary brought together to support the project core team as required. Establishing KPI’s for the project, dashboard metrics and reporting out of progress on a regular basis. The SPM will the responsible to ensure that the key project deliverables are met and delivered on time. With the effective integration of the new manufacturing facility into the established Ethicon Biosurgery supply chain and handover to the base business operations.
Qualifications
QUALIFICATIONS AND EXPERIENCE:
A Masters Degree in Project Management, Engineering or related Technical field is required. A minimum of 10 years experience in a medical device, pharmaceutical or similar regulated industry is required with a minimum of 3 of those years in a significant leadership role. Previous people management and project management experience is essential. With experience in managing transfers and establishment of complex process and/or facilities a preferred skill set... The candidate must have broad based knowledge and skills in diverse areas of business such as Engineering, Manufacturing Operations, Supply Chain, Quality Assurance, Quality Systems and Regulatory Compliance. A demonstrated knowledge of business impact of compliance issues and risk management. Ability to effectively negotiate and influence upper management in other departments. A broad knowledge of Good Manufacturing Practices, regulations and validation methods.
Excellent communication and interpersonal skills will be essential when dealing with global project teams spread across several countries. A desired skill would be the ability to speak German. Ability to represent J&J in a leadership capacity at a variety of external forums is required. This position will be located either in Europe or Israel and will require up to 50% travel within the EMEA region.
If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today.
Primary Location(s) (Europe/Middle East)
Central Europe nr. Vienna, Austria: Tel-Aviv /Jerusalem area, Israel.
Primary Location:Europe/Middle East/Africa-Austria
Organization: Johnson & Johnson Vision Care (Ireland) Limited (8182)
Job Function: Plant Management
Description
Position Title: Senior Project Manager External Manufacturing
Department: Ethicon Biosurgery External Manufacturing
Report to: Program Director External Manufacturing
Location: Europe, Israel.
MD&D Global Biologics is currently recruiting for a Snr. Project Manager – External Manufacturing Operations The position can be located in Europe or Israel
Global Biologics is currently comprised primarily of the Ethicon Biosurgery Business Unit which is a unique business that includes medical devices, biologics and combination device/biologic products. It is comprised of the Omrix business in Israel, the newly acquired BioSeal business in China, the JJWM legacy businesses as well as several strategic external partnerships.
Reporting to the Program Director for External Manufacturing, the Senior Project Manager (SPM) – External Manufacturing will provide project leadership for the technical transfers and establishment of duplicate drug substance biologic manufacturing operations from the Omrix facilities in Israel to a new external manufacturing partner. The partner Octapharma GmbH is based in Vienna Austria. The candidate will establish and help build the cross functional project core teams to deliver the project goals and objectives to meet the business needs.
The candidate will interact and collaborate with the following teams on a regular basis: Omrix Operations Leadership Team, Global Biologics Operations Leadership Team, Franchise Operations Development Team, Quality Operations Leadership Team, Global Surgery Supply Chain Leadership Team, Ethicon Biosurgery sponsors and key stakeholders, Octapharma leadership & key stakeholders, Corporate WWEng. Personnel.
SCOPE & MAIN RESPONSIBILITIES:
The Senior Project Manager (SPM) will lead a diverse internationally based core team and SME’s. The core team members will represent all the major functions within the Omrix and wider Ethicon Biosurgery organizations.
Will work closely with the Octapharma leadership and core team.
• Establishing a close cross company relationship. ensuring that both project teams are aligned:
• A common set of goals and final project objectives with a well defined scope
• Ensure that day to day tracking and progress is maintained at to meet the project timelines
• Management and impact of scope changes
• Ensure all Ethicon Biosurgery requirements are met in the on-going project execution at Octapharma. Clear design requirements and specifications are understood and communicated to establish the new manufacturing facility
• Appropriate project management, design control and design verification process is established between the teams that fit within the established project management procedures and quality systems.
Work closely with the Ethicon Biosurgery core team to ensure
• Those adequate resources are made available by the functional leaders to support the project.
• Define the project priorities and establish clear goals and objectives within each work stream
• Ensure all work stream leaders within the core team are tracking and reporting out progress
• Establish and help facilitate close working relationships between core team members of both teams
• Ensure data transfer and knowledge transfer plans are established and executed to plan
• Establish a project risk management program to ensure all critical risk are identified and mitigated on a continuous basis
• Establish and manage a detailed project budget and report out to the Program Director
The SPM will establish a clear communication plan to ensure that all team members, partners, sponsors and stakeholders are kept informed of progress and where necessary brought together to support the project core team as required. Establishing KPI’s for the project, dashboard metrics and reporting out of progress on a regular basis. The SPM will the responsible to ensure that the key project deliverables are met and delivered on time. With the effective integration of the new manufacturing facility into the established Ethicon Biosurgery supply chain and handover to the base business operations.
Qualifications
QUALIFICATIONS AND EXPERIENCE:
A Masters Degree in Project Management, Engineering or related Technical field is required. A minimum of 10 years experience in a medical device, pharmaceutical or similar regulated industry is required with a minimum of 3 of those years in a significant leadership role. Previous people management and project management experience is essential. With experience in managing transfers and establishment of complex process and/or facilities a preferred skill set... The candidate must have broad based knowledge and skills in diverse areas of business such as Engineering, Manufacturing Operations, Supply Chain, Quality Assurance, Quality Systems and Regulatory Compliance. A demonstrated knowledge of business impact of compliance issues and risk management. Ability to effectively negotiate and influence upper management in other departments. A broad knowledge of Good Manufacturing Practices, regulations and validation methods.
Excellent communication and interpersonal skills will be essential when dealing with global project teams spread across several countries. A desired skill would be the ability to speak German. Ability to represent J&J in a leadership capacity at a variety of external forums is required. This position will be located either in Europe or Israel and will require up to 50% travel within the EMEA region.
If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today.
Primary Location(s) (Europe/Middle East)
Central Europe nr. Vienna, Austria: Tel-Aviv /Jerusalem area, Israel.
Primary Location:Europe/Middle East/Africa-Austria
Organization: Johnson & Johnson Vision Care (Ireland) Limited (8182)
Job Function: Plant Management