Senior Process Engineer, Technical Operations - Small Molecule Drug Product (Oral Solid Dose)

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:

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

- Provide technical input to the Capital Project Team, supporting:

- 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

- Equipment capability and process comparability assessments

- 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

- Process robustness (e.g. compaction consistency, compression stability)

- Lead or drive continuous improvement initiatives aligned with operational excellence

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

- Coating defects (e.g. color variation, twinning, roughness)

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

- Contribute to line optimization, changeover reduction, and debottlenecking activities

- Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards

- Provide technical leadership in campaign preparation, execution, and post-campaign review

- Own and approve batch record updates, process specifications and control strategies

- Support regulatory inspections and audits, providing technical input and ensuring inspection readiness

- Ensure high standards of data integrity and technical documentation

- Act as a technical representative across Manufacturing, Quality, Engineering, Supply Chain, and R&D

- Provide clear technical direction and influence decision-making across product introductions and commercial operations

- Lead or contribute to cross-functional initiatives , ensuring alignment to timelines and site objectives

- Support knowledge sharing and best practice transfer across internal and external networks

- Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline

- Typically 5+ years' experience in oral solid dose manufacturing, formulation, or process development (PhD may offset experience)

- Strong experience in OSD manufacturing operations , particularly:

- Experience in process scale-up and commercialization of solid oral dosage forms

- Good understanding of cGMP manufacturing and regulatory expectations

- Experience troubleshooting tableting and coating processes in a commercial environment

- Strong analytical capability with ability to interpret process and product performance data

- Demonstrated ability to lead technical workstreams or projects

- Excellent problem-solving skills with structured, science-based approach

- Effective communicator with ability to influence cross-functional stakeholders

- Proven ability to manage multiple priorities in a dynamic manufacturing environment

- Proactive, self-driven mindset with strong focus on continuous improvement and ownership

We keep the patient at the heart of everything we do and strive to deliver solutions for some of the world's most challenging healthcare needs. We believe innovation happens when empowered individuals collaborate in an inclusive, high-performing environment.

- Play a key role in delivering oral solid dose manufacturing capability

- Take ownership of formulation and process performance at commercial scale

- Develop as a technical leader in a high-impact manufacturing environment

Required Skills: Adaptability, Biopharmaceutical Industry, Change Control Processes, Chemical Engineering, Customer-Oriented, Deviation Management, Engineering Standards, Equipment Selection, Good Manufacturing Practices (GMP), Maintenance Engineering, Manufacturing Process Validation, Operational Excellence, Oral Solid Dosage, Pharmaceutical Sciences, Process Optimization, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Teamwork, Technical Leadership, Technical Support, Technical Transfer, Technology Transfer, Vibratory Rollers

Job Posting End Date: 08/15/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.