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STERLING PHARMA SOLUTIONS Commercial Technical in GERMANTOWN, Wisconsin

JOB REQUIREMENTS: Duties and Responsibilties of Job: Summary of the role As the Technical Manager, Commercial Products, you are directing commercial product support activities. The Technical Manager is responsible for coordinating the direction of process performance monitoring and identifying and leading process improvements. The Technical Manager directs their team on the execution and gaps associated with the control strategy, process design, and unit operation and equipment support while ensuring appropriate communication and partnership with the key stakeholders external to the technical team (e.g., production, EH&S, QC, and QA). The incumbent will play a key role in external communication with the customer in support of the Partnership Manager and is responsible for the collaborative development and performance of the technical team members. The Manager ensures a high level of execution during the manufacturing phase of the program, in alignment with the deliverables in the contract, and providing a high level of intrinsic value addition to the product. Your responsibilities * Leads planning and technical support for execution of commercial product production. * Ensures that the product documentation and deliverables are kept up-to-date with the relevant data pertaining to regulatory status, process performance, supply chain and production activities. * Is responsible for the scientific substance of processes, ensuring accountability of team members to functional standard work deliverables as well as their integration with other technical functions. * Embraces and develops a culture of innovation for the purpose of adding value to the commercial portfolio. * Owns the change management process for the introduction of process improvements and gap remediation on the commercial product portfolio. * Leads the technical team in execution of investigations, continuous process verification protocols, reports, and reviews. * Works closely with the manufacturing organization to identify improvements and provide support from the production engineering and support chemistry teams. * Leads technical initiatives cross-functionally to improve the right-first-time execution of production campaigns; identifying and reducing sources of variation and risk. * Works closely with Regulatory and CMC functions to evaluate potential impact of proposed changes. * Coordinates the generation of updates, reports, protocols and governance packages, ensuring scientific and executional accuracy. * Leads technical writing team in the planning and execution of quality document (e.g. Master Production Record) creation and associated template creation, updates, and templates to drive consistency, quality and executability. * Ensures readiness of development outputs (materials, technical documents and work plans) and drives deliverables with the team for manufacturing readiness (STR\'s, MPR\'s, MACO\'s, materials, methods, etc.). * Ensures that production campaigns (if required) are supervised by the technical team. * Is the primary contact for customers and auditors concerning the scientific aspects of products. * Contributes to project technical evaluations for the purpose of product costing evaluation for commercial supply agreements. * Directly leads team of approximately 3 - 7 direct reports. * Embodying our company values, which are: be reliable, be caring, be transparent and be willing. Requirements for the role * Bachelor\'s Degree (Chemistry, Pharmaceutical Sciences, Engineering, or related) required. * Master\'s or Doctorate Degree preferred. * 5-7 years of related experience required; 12+ years preferred. * Prior pharmaceutical experience required; prior CDMO experience preferred. What we offer We offer To view the full job description please use the link below. https://www.aplitrak.com/?adid=YmJnZW5lcmljLjYxMDc5Ljg3NzBAc3Rlcmxpbmdwc2xjb21wLmFwbGl0cmFrLmNvbQ ***** APPLICATION INSTRUCTIONS: Apply Online: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjYxMDc5Ljg3NzBAc3Rlcmxpbmdwc2xjb21wLmFwbGl0cmFrLmNvbQ

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