Foreign Trade Zone Operations Manager

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. This role: The FTZ Manager will be responsible for overseeing all aspects of the company's Foreign Trade Zone program in compliance with U.S. Customs and Border Protection (CBP) regulations and FTZ Board requirements. This is a critical compliance and operations leadership role that requires deep knowledge of FTZ regulations, strong organizational skills, and the ability to work cross-functionally with customs brokers, warehouse teams, and clients. This position is on site in Bloomington, Indiana. The responsibilities: Oversee all daily Foreign Trade Zone (FTZ) activities, including admissions, transfers, manipulations, and exports, ensuring full compliance with CBP regulations and the FTZ Act. Maintain precise inventory records in the FTZ management system; perform timely inventory reconciliation and cycle counts. Prepare and submit all regulatory reports, such as FTZ Annual Reports, statistical data, implement corrective measures as needed, and CBP entry documentation. Act as the main point of contact with CBP port directors, the FTZ Board, and external auditors. Develop, update, and enforce FTZ standard operating procedures, policies, and internal controls to ensure ongoing compliance. Conduct ongoing training for warehouse and operations teams on FTZ protocols, recordkeeping standards, and regulatory changes. Track changes in FTZ regulations, CBP rulings, and trade policies; evaluate operational impacts and adapt procedures accordingly. Coordinate with customs brokers and freight forwarders to maximize duty deferral, inversion, and elimination benefits for clients. Support FTZ activation and expansion, including site surveys, application preparation, and Board approvals. Partner with IT and operations teams to maintain and enhance the FTZ inventory management system. Lead, mentor, and develop a team of employees. Work collaboratively with internal teams (supply chain, finance, legal) and external partners (customs brokers, freight forwarders, government agencies) to optimize FTZ operations. Required qualifications: Bachelor's degree (preferably in Business, Supply Chain Management, Logistics, or a related field) Minimum 3–5 years of experience managing a Foreign Trade Zone operation, customs and logistics. In-depth know…

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