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Commercial Technical Manager - Sterling
Commercial Technical Manager - Sterling-March 2024
Germantown
Mar 28, 2026
About Commercial Technical Manager - Sterling

  JOB REQUIREMENTS: Duties and Responsibilties of Job: Summary of the roleAs the Technical Manager, Commercial Products, you are directingcommercial product support activities. The Technical Manager isresponsible for coordinating the direction of process performancemonitoring and identifying and leading process improvements. TheTechnical Manager directs their team on the execution and gapsassociated with the control strategy, process design, and unit operationand equipment support while ensuring appropriate communication andpartnership with the key stakeholders external to the technical team(e.g., production, EH&S, QC, and QA). The incumbent will play a key rolein external communication with the customer in support of thePartnership Manager and is responsible for the collaborative developmentand performance of the technical team members. The Manager ensures ahigh level of execution during the manufacturing phase of the program,in alignment with the deliverables in the contract, and providing a highlevel of intrinsic value addition to the product. Your responsibilities* Leads planning and technical support for execution of commercialproduct production. * Ensures that the product documentation anddeliverables are kept up-to-date with the relevant data pertaining toregulatory status, process performance, supply chain and productionactivities. * Is responsible for the scientific substance of processes,ensuring accountability of team members to functional standard workdeliverables as well as their integration with other technicalfunctions. * Embraces and develops a culture of innovation for thepurpose of adding value to the commercial portfolio. * Owns the changemanagement process for the introduction of process improvements and gapremediation on the commercial product portfolio. * Leads the technicalteam in execution of investigations, continuous process verificationprotocols, reports, and reviews. * Works closely with the manufacturingorganization to identify improvements and provide support from theproduction engineering and support chemistry teams. * Leads technicalinitiatives cross-functionally to improve the right-first-time executionof production campaigns; identifying and reducing sources of variationand risk. * Works closely with Regulatory and CMC functions to evaluatepotential impact of proposed changes. * Coordinates the generation ofupdates, reports, protocols and governance packages, ensuring scientificand executional accuracy. * Leads technical writing team in theplanning and execution of quality document (e.g. Master ProductionRecord) creation and associated template creation, updates, andtemplates to drive consistency, quality and executability. * Ensuresreadiness of development outputs (materials, technical documents andwork plans) and drives deliverables with the team for manufacturingreadiness (STR\'s, MPR\'s, MACO\'s, materials, methods, etc.). *Ensures that production campaigns (if required) are supervised by thetechnical team. * Is the primary contact for customers and auditorsconcerning the scientific aspects of products. * Contributes to projecttechnical evaluations for the purpose of product costing evaluation forcommercial supply agreements. * Directly leads team of approximately3 - 7 direct reports. * Embodying our company values, which are: bereliable, be caring, be transparent and be willing. Requirements for therole * Bachelor\'s Degree (Chemistry, Pharmaceutical Sciences,Engineering, or related) required. * Master\'s or Doctorate Degreepreferred. * 5-7 years of related experience required; 12+ yearspreferred. * Prior pharmaceutical experience required; prior CDMOexperience preferred. What we offer We offer To view the full jobdescription please use the link below.https://www.aplitrak.com/?adid=YmJnZW5lcmljLjAyMzExLjg3NzBAc3Rlcmxpbmdwc2xjb21wLmFwbGl0cmFrLmNvbQ***** APPLICATION INSTRUCTIONS: Apply Online:https://www.aplitrak.com/?adid=YmJnZW5lcmljLjAyMzExLjg3NzBAc3Rlcmxpbmdwc2xjb21wLmFwbGl0cmFrLmNvbQ

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