Senior Manager, ExM and MS&T

Location: Parsippany

## We Are Teva

We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

## Our Team, Your Impact

The Sr. Manager MS&T External Manufacturing as individual contributor role at Teva Global ExM and will be responsible for leading technical and manufacturing operation-related engagements with external manufacturing partners (e.g., contract manufacturing organizations or CMOs).

The Role will provide:

* Technical support for External Pharmaceutical Manufacturing Network to ensure operational excellence, product quality, and optimal product flow to respective markets.

* Works with the regional/global commercial sites to facilitate new and in-line technology transfer and commercialization projects.

* Scale up, Technology transfer and Validation

* Providing technical intelligence to deviations, technical complaints, OOE, OOT, OOS & CAPAs, while ensuring manufacturing processes adhering to highest quality standards, compliance with regulatory requirements

* Process improvements

* Standards and new technology deployment

* Following all applicable Global SOPs and Guidelines

Thus, the role will provide stewardship by ensuring that both manufacturing operations at external suppliers and performance of Teva products are monitored & maintained in a validated state

The ideal candidate will have a strong technical background in manufacturing sciences, process optimization, and a thorough understanding of Good Manufacturing Practices (cGMP), Project Management, IR or MR OSD products OR simple or complex injectables OR topical products experience and will be adept at managing cross-functional teams to drive successful outcomes with external partners

## How You'll Spend Your Day

External Manufacturing Partner Management

* Build and maintain strong relationships with CMO/CDMO partners to support product manufacturing, process development, scale-up, and technology transfer activities.

* Provide technical expertise on process optimization, troubleshooting, and manufacturing improvements.

* Monitor partner performance across quality, cost, delivery, efficiency, and compliance metrics, ensuring alignment with Teva standards.

* Serve as the primary technical and operational contact for external manufacturing issues and escalate risks when necessary.

Process Development & Optimization

* Oversee manufacturing processes to ensure compliance with product specifications, regulatory requirements, and Teva expectations.

* Drive process optimization initiatives to improve efficiency, yield, robustness, scalability, and operational performance.

* Lead technical support for product scale-up and transfers from development through commercial manufacturing.

* Implement and manage continuous improvement initiatives at external manufacturing sites.

Quality & Regulatory Compliance

* Ensure compliance with cGMP, ICH, FDA, EMA, and other applicable regulations.

* Utilize quality and regulatory document management systems such as Veeva, GRIDS, Harmony TW, or similar platforms.

* Support audits, inspections, and regulatory submissions while ensuring external partners meet quality standards.

* Lead investigations, root cause analyses, deviation management, and CAPA implementation for manufacturing issues.

Technology Transfer & Scale-Up

* Conduct due diligence, site selection, technical gap assessments, and remediation planning.

* Lead technology transfers for multiple products, including IR/MR oral solid dosage forms, injectables, and topical products.

* Manage material transfer projects involving API, excipient, or process changes.

* Oversee scale-up activities to ensure commercial manufacturing performance is consistent with development and validation batches.

## Your Skills and Experience

Education

*…