CSC DS External Bio Strategic Lead

Local Jobs Johnson & Johnson Family of Companies
  • United States, Malvern, PA View on Map
  • Post Date : October 19, 2020
  • Apply Before : November 18, 2020
  • Share:

Job Description

Business Description:

The Janssen Biologics Platform organization of the Clinical Supply Chain (CSC) is responsible for the production of Drug Substance (DS) clinical supplies (mAbs, and multispecifics) at 3rd party contract manufactures (CMO’s) when applicable.

The CSC DS External Biologics Strategic Lead is the key point of contact for handling the CMO relationship and coordinating the activities required to ensure the manufacturing and delivery of clinical supplies per CMC timelines.


Description of the Role:

  • Lead the overall relationship with internal / external manufactures and coordinate activities to ensure the manufacturing and delivery of API clinical material per CMC timelines.
  • Partner with JSC colleagues to ensure on-time supply of material to internal sites for further processing.
  • Partner with Global Planning in the planning of production schedules and capacity. Figure out impact of forecast changes on scheduling and cost.
  • Source raw materials and components as required. Point of contact for material and supplier related issues at CMO.
  • Partner with Quality colleagues to conduct Engineering and Cross-Contamination Risk Assessments. Identify and mitigate any risks prior to GMP processing of clinical materials.
  • Participate in CMC sub-teams and cross-functional meetings as needed to provide sourcing and operational expertise.
  • Prepare business plan forecasts and monitor actual spend vs budget.
  • Identify metrics to monitor the health of the business relationship. Partner with CMO to regularly review business performance.
  • Find opportunities to lower costs or improve existing business processes.
  • Partner with Procurement and Legal groups to develop supply agreements and ensure adherence when implemented.
  • Partner with the Process Development and Commercial organisations in the identification and assessment of potential new CMO’s.
  • Prepare cost and time estimates for new technology platforms and products in development or acquired thru L&A deals.
  • Participate in Due Diligence assessments. Provide manufacturing and supply chain expertise to help evaluate L&A opportunities.
  • In collaboration with the CMO and other Janssen functional reps, review required GMP documentation for manufacturing.
  • Provide technical support and partner with CMO and Janssen colleagues in the investigation, resolution and implementation of corrective actions for any process or procedural issues.
  • Ensure CMO adherence to GXP, regulatory, and Janssen procedures, along with applicable Engineering, Safety, and Industrial Hygiene standards.
People Management:

  • Responsible for implementation of the Performance review process – i.e. Goal & Objective setting, mid-year and year-end reviews.
  • Issue project assignments, monitor workload, and provide daily guidance to staff.
  • Mentor and coach staff, conduct regular 1-on-1 meetings, and identify development opportunities.
  • Ensure a broad environment and be a model of Credo behavior.

Qualifications


Qualifications:

  • A Bachelor’s Degree in the Life Sciences or Engineering is required.
  • A minimum of a BS with 10 years or an MS with 8 years of experience.
  • Experience in clinical or commercial manufacturing is required.
  • Prior experience working with a CMO is preferred.
  • Aseptic processing knowledge and experience is required.
  • Knowledge of cGMP’s and Agency requirements for bio-pharmaceutical manufacturing is required.
  • General knowledge of process equipment, utilities, and design requirements for a bio-pharmaceutical manufacturing facility is required.
  • Ability to effectively apply project management tools to lead projects and programs is required. Knowledge of FPx is preferred.
  • Understanding of planning, material handling, manufacturing, and GMP-compliance related to the manufacturing of bio-pharmaceuticals is required.
  • Understanding of manufacturing cost drivers is required. Previous budget experience is preferred.
Biologics Platform:


This position may be located in Malvern PA, Cork IRL, Leiden NED, and may require up to 30% travel.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

INDHP


Primary Location

Norway-
Other Locations
Netherlands-South Holland-Leiden, United States-Pennsylvania-Malvern, Ireland-Cork-Cork
Organization
Janssen R&D Ireland (7566)
Job Function
R&D
Requisition ID
2005849175W

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CSC DS External Bio Strategic Lead

Local Jobs Johnson & Johnson Family of Companies
  • United States, Malvern, PA View on Map
  • Post Date : October 14, 2020
  • Apply Before : November 13, 2020
  • Share:

Job Description

Business Description:

The Janssen Biologics Platform organization of the Clinical Supply Chain (CSC) is responsible for the production of Drug Substance (DS) clinical supplies (mAbs, and multispecifics) at 3rd party contract manufactures (CMO’s) when applicable.

The CSC DS External Biologics Strategic Lead is the key point of contact for handling the CMO relationship and coordinating the activities required to ensure the manufacturing and delivery of clinical supplies per CMC timelines.


Description of the Role:

  • Lead the overall relationship with internal / external manufactures and coordinate activities to ensure the manufacturing and delivery of API clinical material per CMC timelines.
  • Partner with JSC colleagues to ensure on-time supply of material to internal sites for further processing.
  • Partner with Global Planning in the planning of production schedules and capacity. Figure out impact of forecast changes on scheduling and cost.
  • Source raw materials and components as required. Point of contact for material and supplier related issues at CMO.
  • Partner with Quality colleagues to conduct Engineering and Cross-Contamination Risk Assessments. Identify and mitigate any risks prior to GMP processing of clinical materials.
  • Participate in CMC sub-teams and cross-functional meetings as needed to provide sourcing and operational expertise.
  • Prepare business plan forecasts and monitor actual spend vs budget.
  • Identify metrics to monitor the health of the business relationship. Partner with CMO to regularly review business performance.
  • Find opportunities to lower costs or improve existing business processes.
  • Partner with Procurement and Legal groups to develop supply agreements and ensure adherence when implemented.
  • Partner with the Process Development and Commercial organisations in the identification and assessment of potential new CMO’s.
  • Prepare cost and time estimates for new technology platforms and products in development or acquired thru L&A deals.
  • Participate in Due Diligence assessments. Provide manufacturing and supply chain expertise to help evaluate L&A opportunities.
  • In collaboration with the CMO and other Janssen functional reps, review required GMP documentation for manufacturing.
  • Provide technical support and partner with CMO and Janssen colleagues in the investigation, resolution and implementation of corrective actions for any process or procedural issues.
  • Ensure CMO adherence to GXP, regulatory, and Janssen procedures, along with applicable Engineering, Safety, and Industrial Hygiene standards.
People Management:

  • Responsible for implementation of the Performance review process – i.e. Goal & Objective setting, mid-year and year-end reviews.
  • Issue project assignments, monitor workload, and provide daily guidance to staff.
  • Mentor and coach staff, conduct regular 1-on-1 meetings, and identify development opportunities.
  • Ensure a broad environment and be a model of Credo behavior.

Qualifications


Qualifications:

  • A Bachelor’s Degree in the Life Sciences or Engineering is required.
  • A minimum of a BS with 10 years or an MS with 8 years of experience.
  • Experience in clinical or commercial manufacturing is required.
  • Prior experience working with a CMO is preferred.
  • Aseptic processing knowledge and experience is required.
  • Knowledge of cGMP’s and Agency requirements for bio-pharmaceutical manufacturing is required.
  • General knowledge of process equipment, utilities, and design requirements for a bio-pharmaceutical manufacturing facility is required.
  • Ability to effectively apply project management tools to lead projects and programs is required. Knowledge of FPx is preferred.
  • Understanding of planning, material handling, manufacturing, and GMP-compliance related to the manufacturing of bio-pharmaceuticals is required.
  • Understanding of manufacturing cost drivers is required. Previous budget experience is preferred.
Biologics Platform:


This position may be located in Malvern PA, Cork IRL, Leiden NED, and may require up to 30% travel.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

INDHP


Primary Location

Norway-
Other Locations
Netherlands-South Holland-Leiden, Ireland-Cork-Cork, United States-Pennsylvania-Malvern
Organization
Janssen R&D Ireland (7566)
Job Function
R&D
Requisition ID
2005849175W

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