Translate Bio

Job Title: Senior Director, External Manufacturing and Manufacturing & Technical Services (MS&T)

Job Number: 22591

Location: Lexington, Massachusetts

Job Description

Translate Bio is seeking a Sr Director, External Manufacturing and MS&T who will manage multiple CMC clinical development products and projects with CMOs, as well as the overall Supply Chain network to the internal and/or external customer. The role will also develop and lead the Manufacturing & Technical Science (MS&T) function. This role leads external manufacturing function at Translate Bio and assists the cross-functional interaction among the internal Technical Operations team (CMC, Tech Development, Supply Chain, Quality, Engineering), Program Management, Regulatory, and the CMO, particularly being responsible for the interaction with the CMO project managers. S/he supports the development of CMO project budgets, timelines, and risk assessments, and is responsible for performance against these parameters. The individual actively monitors and reports on project status, the financial status of the work within the CMOs, interacts regularly with the program core team and other functions as necessary to communicate the risks and decisions required and highlights assumptions associated with CMC manufacturing and supply timelines. S/he will lead the MS&T function, which is responsible to maintain and improve the
scientific oversight of the manufacturing processes and technical changes, and the relevant body of technical knowledge and capabilities at the CMO’s. The role reports into Translate Bio’s SVP Technical Operations.

Responsibilities

External Manufacturing and Supply

  • Develops and implements overall strategy for External Manufacturing and Supply, in collaboration with other Technical Operations functions
  • Ensure External Network readiness to handle rapid changes in the business
  • Drive contract development, review and approval with Legal, Finance and Translate Bio’s leadership team
  • Lead the development of external CMO project plans for existing and envisioned projects, with input from key Technical Operations functions and stakeholders
  • Manages overall External Manufacturing budget and spend, carefully balancing risk and cost
  • Responsible for external GMP warehouse and storage facilities for M/WCBs, DS and DP, and the overall Supply Chain network for clinical trial material distribution
  • As member of CMC project teams, provide estimates for the resources, cost, timeline tasks, and alternative options to accomplish desired CMO schedule
  • Coordinate the interaction of the CMC cross-functional projects among Translate Bio personnel, and between Translate Bio and the CMOs.
  • Work closely with CMOs used to produce GMP material, using site visits and frequent communication with CMO team members to update status of CMC project
  • Interact with CMC project and program core teams to ensure alignment of external plan with overall CMC and program strategy, and the requirements of pre-clinical and clinical teams.
  • Monitor scope, milestones, dependencies, and costs associated with CMO/CRO project and the timelines for CMO/CRO deliverables.
  • Drive projects through project goals to ensure compliance to defined schedule.
  • Interact with finance to appraise them of changes in cost and assignment of work orders to specific functions and tasks
  • Create and maintain comprehensive risk management plan for product production
  • Working with CMC teams, provide effective mitigation and escalation strategies for project risks and issues.
  • Manage short and long-term project commitments to supply of drug substance and drug product and communicate levels to internal project teams.
  • Develop and update standard external CMC CMO plans, based on process and historical data, to provide guidance on cost and FTEs required to manage and produce GMP material for new development projects
  • Manage transition of CMC projects/products from early stage to late stage production at a CMO.
  • Strengthen and maintain relationships with key Translate Bio project team employees and outside vendors and suppliers of CMO services.
  • Assist in coordinating key vendor and supplier evaluations, particularly those supplying services related to raw material supply, product manufacturing, release, storage, and characterization.

MS&T

  • Ensure robust product stewardship for the all products manufactured at the CMO, and end-to-end technical oversight of product manufacturing processes
  • Ensure single point of contact for products at CMO’s with respect to process technical issues.
  • Safeguard, maintain, and manage the knowledge and scientific information of product processes.
  • Oversee and ensure the robustness and capability of DS, DP, and Finished Goods manufacturing processes by monitoring each product’s Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs).
  • Partner with technical research and development organizations to ensure a robust commercial scale-up of new products/processes.
  • Lead technical transfer activities to the CMO’s.
  • Lead process validation and ensure ongoing validated status of the process in accordance with the VMP, when required.
  • Ensure oversight of technical changes and lead end-to-end change control management related to technical issues, working cross-functionally as required.
  • Review and releases relevant manufacturing information required for regulatory filings.
  • Process manufacturing standards management (e.g. write SOPs and manufacturing instructions).
  • Rigorously sets and applies appropriate technical standards for DS, DP and Finished Goods manufacturing by employing new/modern processes and technologies (e.g. Quality by Design (QbD), Design of Experiment (DOE), and Process Analytical Technologies (PAT))
  • Lead cross-functional root cause analysis and problem solving on technical process issues (e.g., recurring deviations, quality-investigations, CAPA-studies).
  • Support the identification and implementation of new technologies, equipment, and equipment capability improvements against standard performance targets.
  • Lead and manage active process and knowledge management within a QbD framework
  • Support technical career path development (e.g., define performance expectations).
  • Drive a culture of quality and compliance across the MS&T and Site team.
  • Work collaboratively with functional management in technical research and development organization and technical operations to ensure that projects such as quality/compliance improvement, cost of goods reduction, etc. are identified, prioritized and delivered with excellence.

Required Skills

External Manufacturing and Supply

  • Develops and implements overall strategy for External Manufacturing and Supply, in collaboration with other Technical Operations functions
  • Ensure External Network readiness to handle rapid changes in the business
  • Drive contract development, review and approval with Legal, Finance and Translate Bio’s leadership team
  • Lead the development of external CMO project plans for existing and envisioned projects, with input from key Technical Operations functions and stakeholders
  • Manages overall External Manufacturing budget and spend, carefully balancing risk and cost
  • Responsible for external GMP warehouse and storage facilities for M/WCBs, DS and DP, and the overall Supply Chain network for clinical trial material distribution
  • As member of CMC project teams, provide estimates for the resources, cost, timeline tasks, and alternative options to accomplish desired CMO schedule
  • Coordinate the interaction of the CMC cross-functional projects among Translate Bio personnel, and between Translate Bio and the CMOs.
  • Work closely with CMOs used to produce GMP material, using site visits and frequent communication with CMO team members to update status of CMC project
  • Interact with CMC project and program core teams to ensure alignment of external plan with overall CMC and program strategy, and the requirements of pre-clinical and clinical teams.
  • Monitor scope, milestones, dependencies, and costs associated with CMO/CRO project and the timelines for CMO/CRO deliverables.
  • Drive projects through project goals to ensure compliance to defined schedule.
  • Interact with finance to appraise them of changes in cost and assignment of work orders to specific functions and tasks
  • Create and maintain comprehensive risk management plan for product production
  • Working with CMC teams, provide effective mitigation and escalation strategies for project risks and issues.
  • Manage short and long-term project commitments to supply of drug substance and drug product and communicate levels to internal project teams.
  • Develop and update standard external CMC CMO plans, based on process and historical data, to provide guidance on cost and FTEs required to manage and produce GMP material for new development projects
  • Manage transition of CMC projects/products from early stage to late stage production at a CMO.
  • Strengthen and maintain relationships with key Translate Bio project team employees and outside vendors and suppliers of CMO services.
  • Assist in coordinating key vendor and supplier evaluations, particularly those supplying services related to raw material supply, product manufacturing, release, storage, and characterization.

MS&T

  • Ensure robust product stewardship for the all products manufactured at the CMO, and end-to- end technical oversight of product manufacturing processes
  • Ensure single point of contact for products at CMO’s with respect to process technical issues.
  • Safeguard, maintain, and manage the knowledge and scientific information of product processes.
  • Oversee and ensure the robustness and capability of DS, DP, and Finished Goods manufacturing processes by monitoring each product’s Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs).
  • Partner with technical research and development organizations to ensure a robust commercial scale-up of new products/processes.
  • Lead technical transfer activities to the CMO’s.
  • Lead process validation and ensure ongoing validated status of the process in accordance with the VMP, when required.
  • Ensure oversight of technical changes and lead end-to-end change control management related to technical issues, working cross-functionally as required.
  • Review and releases relevant manufacturing information required for regulatory filings.
  • Process manufacturing standards management (e.g. write SOPs and manufacturing instructions).
  • Rigorously sets and applies appropriate technical standards for DS, DP and Finished Goods manufacturing by employing new/modern processes and technologies (e.g. Quality by Design (QbD), Design of Experiment (DOE), and Process Analytical Technologies (PAT))
  • Lead cross-functional root cause analysis and problem solving on technical process issues (e.g., recurring deviations, quality-investigations, CAPA-studies).
  • Support the identification and implementation of new technologies, equipment, and equipment capability improvements against standard performance targets.
  • Lead and manage active process and knowledge management within a QbD framework
  • Support technical career path development (e.g., define performance expectations).
  • Drive a culture of quality and compliance across the MS&T and Site team.
  • Work collaboratively with functional management in technical research and development organization and technical operations to ensure that projects such as quality/compliance improvement, cost of goods reduction, etc. are identified, prioritized and delivered with excellence.

 

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