Senior Process Engineer, Technical Operations – Molecule Drug Product; Oral Solid Dose

Job Description

We have an exciting opportunity for a Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Oral Solid Dose) to join our growing team.

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.

At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

The successful candidate will provide technical leadership and process ownership supporting facility design, commissioning, qualification, and startup through to technology transfer, validation, and ongoing commercial manufacture of oral solid dosage forms.

In this role, you will work as a key member of a cross‑functional team, initially supporting the capital project and transitioning into process lead responsibilities across technology transfer and commercial manufacturing, driving technical excellence and operational performance.

Provide technical leadership for oral solid dose manufacturing processes, including:

• Blending and granulation (where applicable)
• Roller compaction (dry granulation)
• Tablet compression
• Film coating and finishing operations

Act as process owner / SME for assigned unit operations, equipment, or product processes

Provide technical input to the Capital Project Team, supporting:

• Equipment selection and design reviews
• Commissioning and qualification (CQV)
• Startup readiness for OSD manufacturing lines

Lead or coordinate process scale‑up, technology transfer, and validation activities (e.g. process performance qualification – PPQ)

Analyze and interpret process and product data (e.g. blend uniformity, tablet properties, coating performance) to drive data‑driven decision‑making and performance improvements

Provide advanced troubleshooting support for compression, compaction, and coating issues (e.g. weight variability, hardness, sticking/picking, coating defects)

Lead or play a key role in execution of technology transfers for oral solid dose products into the facility

Partner with global R&D and network sites to ensure robust transfer of formulation and process knowledge

Drive:

• Process fit assessments
• Scale‑up strategy from development to commercial scale
• Equipment capability and process comparability assessments

Own or guide development and optimization of:

• Master batch records (MBRs)
• Process descriptions and control strategies

Support integration and industrialization of new formulations and technologies (e.g. continuous manufacturing, advanced granulation approaches where applicable)

Partner with Manufacturing to ensure safe, efficient, and reliable OSD plant performance

Identify, prioritize, and implement improvements in:

• Content uniformity and tablet quality
• Process robustness (e.g. compaction consistency, compression stability)
• Yield, throughput, and cycle time

Lead or drive continuous improvement initiatives aligned with operational excellence

Use structured problem‑solving approaches (e.g. RCA, DOE where applicable) to resolve:

• Compression issues (e.g. capping, lamination)
• Compaction variability
• Coating defects (e.g. color variation, twinning, roughness)

Monitor process trends and product quality attributes to proactively identify risks and opportunities

Contribute to line…