Jeffrey Lang

FAQ About Jeffrey Lang

• What is Jeffrey Lang's address?

  Jeffrey Lang is located at
  Frankfurt Am Main Area, Frankfurt Am Main Area, Germany

• What is Jeffrey Lang's job title?

  Jeffrey Lang is a
  As the Project Team Leader I was responsible for managing all activities in Pharmaceutical Operations during development, handover, validation, submission, PAI, and commercial launch. I managed a diversified and dynamic portfolio of ca. 10 projects in parallel, 1/3 to 1/2 of which were late phase (pre-validation - launch). The responsibilities involved leading global teams of ca. 10-40 project reports and coordinating activities across development, manufacturing, supply chain, and business functions to consistently meet tight timelines and achieve stretched targets. The teams often included external partner organizations supporting manufacture or development. The projects covered all sterile dosage forms, biologics, devices, inhalation, and some solids.As Production Transfer Manager I was responsible to identify and evaluate drug product transfers between manufacturing sites to support global manufacturing strategy. This involved preparing recommendations and the supporting business cases to the corporate transfer committee for approval, initiating transfer activities, and tracking projects. My additional responsibility as Launch Officer for Diovan, was to support and coach the project team in the resolution of issues.As the Manager of Launch and Changes I was responsible to lead the interfunctional evaluation and approval of all regulatory-relevant change requests in the Pharma division. This involved working together with the affected manufacturing sites in ChemOps and PharmOps, as well as regulatory, and supply chain functions to develop business cases justifying implementation or rejection. I also supported management of the global change process and was responsible to plan and train local change managers during process rollout as well as to coordinate change process improvement initiatives. For launch I was additionally responsible to support implementation of global launch process improvements.As the Manufacturing Unit Head in Chemical Operations I was responsible for leading a team of ca. 25 direct reports and managing a facility making intermediates and API working in 2 and 3 shift operation. This involved planning and managing production operations to ensure consistent on time, in full delivery (ca. 15 chemical intermediates, 1 API) based on global demand projections. I was responsible for oversight of all maintenance, repair and investment activities in the facility and for ensuring all safety and GMP guidelines were met. In an additional role I was responsible to lead and coordinate the introduction of new products into commercial manufacturing facilities.As the Site Champion and Product Group Leader I had a dual role. I was responsible to lead and manage introduction and validation of intermediates and API for a new launch product (15 steps in 4 facilities) in Chemical Operations. Additionally I headed two production support labs (5 direct reports). As Lab Head I was responsible for managing troubleshooting and process improvement activities for the whole department manufacturing more than 50 intermediates and APIs’.As the head of Validation / Qualification I lead a team of approx. 40 direct and indirect reports. We lead and coordinate all qualification, process validation and cleaning validation activities in cooperation with production, QA, MS+T, Engineering, QC, external partners, and other functions for bulk antigens, formulations, media and buffers, and final products manufactured on site. My responsibilities include budgeting, departmental objective setting, personnel development and coaching. We support all inspections and audits for any validation / qualification inquiries. I represent the site in the global validation team. I report to the site head and managing director and am a member of the site leadership team.As the head of the validation and qualification department, I lead a team of approx. 40 direct and indirect reports. We lead and coordinate all qualification, process validation and cleaning validation activities in cooperation with production, QA, MS+T, Engineering, QC, external partners, and other functions for bulk antigens, formulations, media and buffers, and final products manufactured on site. My responsibilities include budgeting, departmental objective setting, personnel development and coaching. We support all inspections and audits for any validation / qualification inquiries. I represent the site in the global validation team. I report to the site head and managing director and am a member of the site leadership team.As the Process Unit Head I had the overall lead and responsibility for setting up a new pharmaceutical manufacturing unit for bulk DP and taking it into commercial operation. This includes management oversight of the facility upgrade team (ca. 40) and ensuring cost, quality, and timelines are met. Additionally I was responsible to set up all systems, SOP’s, and logistic processes for GMP manufacture. This includes budget responsibility, planning and execution of PQ and process validation, as well as recruitment and management of the production team (ca. 10 direct reports).Overall lead for design, construction, commissioning, qualification/validation, licensing, startup, and commercial operation of a new bulk vaccines manufacturing facility (160 Mio € investment). As the "End to End Lead", I head a team of currently approx. 60 direct and indirect reports. We plan, lead and coordinate all design, construction, and process transfer activities in cooperation with site and global functions, external partners, and the relevant authorities to establish a new commercial bulk vaccines manufacturing facility on site. My responsibilities include leading the team through all phases of the project from conceptual design through licensing and heading later commercial operation. I have overall accountability for scope, budget, and timelines. This includes approving design alternatives, setting up and staffing the project team according to developing needs, objective setting, personnel development and coaching. I work together with my workstream leads to plan, manage, and coordinate all activities and review progress as well as support resolution of issues. I report to the site head and managing director and am a member of the site leadership team. Additionally I report project status and escalate issues if needed to the steering and sponser committees.As the head of Manufacturing Science and Technology, I lead a team of approx. 50 direct and indirect reports. We lead and coordinate all qualification, process validation, cleaning validation,and manufacturing support activities in cooperation with production, QA, MS+T, Engineering, QC, external partners, and other functions for bulk antigens, formulations, media and buffers, and final products manufactured on site. My responsibilities include budgeting, departmental objective setting, personnel development and coaching. We support all inspections and audits for any validation / qualification inquiries. I represent the site in the global validation team. I report to the site head and managing director and am a member of the site leadership team. Glaxo Smith Kline Vaccines

• What industry does Jeffrey Lang currently work in?

  Jeffrey Lang currently works in the
  Glaxo Smith Kline Vaccines

• What is Jeffrey Lang's area of expertise?

  Jeffrey Lang specializes in
  As the Project Team Leader I was responsible for managing all activities in Pharmaceutical Operations during development, handover, validation, submission, PAI, and commercial launch. I managed a diversified and dynamic portfolio of ca. 10 projects in parallel, 1/3 to 1/2 of which were late phase (pre-validation - launch). The responsibilities involved leading global teams of ca. 10-40 project reports and coordinating activities across development, manufacturing, supply chain, and business functions to consistently meet tight timelines and achieve stretched targets. The teams often included external partner organizations supporting manufacture or development. The projects covered all sterile dosage forms, biologics, devices, inhalation, and some solids.As Production Transfer Manager I was responsible to identify and evaluate drug product transfers between manufacturing sites to support global manufacturing strategy. This involved preparing recommendations and the supporting business cases to the corporate transfer committee for approval, initiating transfer activities, and tracking projects. My additional responsibility as Launch Officer for Diovan, was to support and coach the project team in the resolution of issues.As the Manager of Launch and Changes I was responsible to lead the interfunctional evaluation and approval of all regulatory-relevant change requests in the Pharma division. This involved working together with the affected manufacturing sites in ChemOps and PharmOps, as well as regulatory, and supply chain functions to develop business cases justifying implementation or rejection. I also supported management of the global change process and was responsible to plan and train local change managers during process rollout as well as to coordinate change process improvement initiatives. For launch I was additionally responsible to support implementation of global launch process improvements.As the Manufacturing Unit Head in Chemical Operations I was responsible for leading a team of ca. 25 direct reports and managing a facility making intermediates and API working in 2 and 3 shift operation. This involved planning and managing production operations to ensure consistent on time, in full delivery (ca. 15 chemical intermediates, 1 API) based on global demand projections. I was responsible for oversight of all maintenance, repair and investment activities in the facility and for ensuring all safety and GMP guidelines were met. In an additional role I was responsible to lead and coordinate the introduction of new products into commercial manufacturing facilities.As the Site Champion and Product Group Leader I had a dual role. I was responsible to lead and manage introduction and validation of intermediates and API for a new launch product (15 steps in 4 facilities) in Chemical Operations. Additionally I headed two production support labs (5 direct reports). As Lab Head I was responsible for managing troubleshooting and process improvement activities for the whole department manufacturing more than 50 intermediates and APIs’.As the head of Validation / Qualification I lead a team of approx. 40 direct and indirect reports. We lead and coordinate all qualification, process validation and cleaning validation activities in cooperation with production, QA, MS+T, Engineering, QC, external partners, and other functions for bulk antigens, formulations, media and buffers, and final products manufactured on site. My responsibilities include budgeting, departmental objective setting, personnel development and coaching. We support all inspections and audits for any validation / qualification inquiries. I represent the site in the global validation team. I report to the site head and managing director and am a member of the site leadership team.As the head of the validation and qualification department, I lead a team of approx. 40 direct and indirect reports. We lead and coordinate all qualification, process validation and cleaning validation activities in cooperation with production, QA, MS+T, Engineering, QC, external partners, and other functions for bulk antigens, formulations, media and buffers, and final products manufactured on site. My responsibilities include budgeting, departmental objective setting, personnel development and coaching. We support all inspections and audits for any validation / qualification inquiries. I represent the site in the global validation team. I report to the site head and managing director and am a member of the site leadership team.As the Process Unit Head I had the overall lead and responsibility for setting up a new pharmaceutical manufacturing unit for bulk DP and taking it into commercial operation. This includes management oversight of the facility upgrade team (ca. 40) and ensuring cost, quality, and timelines are met. Additionally I was responsible to set up all systems, SOP’s, and logistic processes for GMP manufacture. This includes budget responsibility, planning and execution of PQ and process validation, as well as recruitment and management of the production team (ca. 10 direct reports).Overall lead for design, construction, commissioning, qualification/validation, licensing, startup, and commercial operation of a new bulk vaccines manufacturing facility (160 Mio € investment). As the "End to End Lead", I head a team of currently approx. 60 direct and indirect reports. We plan, lead and coordinate all design, construction, and process transfer activities in cooperation with site and global functions, external partners, and the relevant authorities to establish a new commercial bulk vaccines manufacturing facility on site. My responsibilities include leading the team through all phases of the project from conceptual design through licensing and heading later commercial operation. I have overall accountability for scope, budget, and timelines. This includes approving design alternatives, setting up and staffing the project team according to developing needs, objective setting, personnel development and coaching. I work together with my workstream leads to plan, manage, and coordinate all activities and review progress as well as support resolution of issues. I report to the site head and managing director and am a member of the site leadership team. Additionally I report project status and escalate issues if needed to the steering and sponser committees.As the head of Manufacturing Science and Technology, I lead a team of approx. 50 direct and indirect reports. We lead and coordinate all qualification, process validation, cleaning validation,and manufacturing support activities in cooperation with production, QA, MS+T, Engineering, QC, external partners, and other functions for bulk antigens, formulations, media and buffers, and final products manufactured on site. My responsibilities include budgeting, departmental objective setting, personnel development and coaching. We support all inspections and audits for any validation / qualification inquiries. I represent the site in the global validation team. I report to the site head and managing director and am a member of the site leadership team.

• Which languages does Jeffrey Lang speak? 

  Jeffrey Lang speaks the following languages:
  No languages available.

• Which industries has Jeffrey Lang previously worked in?   

  Jeffrey Lang has prior experience in the following industries:
  Glaxo Smith Kline Vaccines , Glaxo Smith Kline Vaccines , Glaxo Smith Kline Vaccines , Novartis Vaccines and Diagnostics , Novartis Pharma , Novartis Pharma , Novartis , Novartis , Novartis , Novartis

• What is Jeffrey Lang’s work experience?  

  Jeffrey Lang has the following professional experience:
  Glaxo Smith Kline Vaccines , Glaxo Smith Kline Vaccines , Glaxo Smith Kline Vaccines , Novartis Vaccines and Diagnostics , Novartis Pharma , Novartis Pharma , Novartis , Novartis , Novartis , Novartis .

• How can I find Jeffrey Lang on LinkedIn?  

  You can view Jeffrey Lang’s
  LinkedIn profile at LinkedIn URL.

• What are Jeffrey Lang’s work email addresses?  

  Jeffrey Lang’s work email addresses are
  [email protected] .

• What company does Jeffrey Lang work for?  

  Jeffrey Lang works at
  Glaxo Smith Kline Vaccines