Sr Process Engineer, Technical Ops-Drug Product (Spray Drying)

Merck; Elkton (VA); On-site; USD 120,000 - 170,000; Full time

Job summary

Merck is seeking a Senior Process Engineer, Technical Operations - Small Molecule Drug Product (Spray Drying) to join our Elkton, VA site. You will lead technical decisions, own spray drying processes, and drive technology transfer from development to commercial manufacture of OSD and intermediates.

You will partner with Manufacturing, QC, Engineering, and Regulatory to deliver safe, compliant, and high-quality drug products, leveraging data-driven approaches and continuous improvement to

Qualifications

• Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline
• Typically 5+ years in drug product intermediate, spray drying, or pharmaceutical process development/manufacturing (PhD may offset experience)
• Strong experience in spray drying and/or particle engineering processes
• Understanding of scale-up principles for spray dryers
• Experience in solid-state characterization (PSD, morphology, amorphous/crystalline control)
• Experience with technology transfer, process validation (PPQ), and regulatory expectations
• Working knowledge of cGMP and regulatory expectations
• Experience with downstream processing into drug product (blending, compaction) desirable

Responsibilities

• Provide technical leadership for drug product intermediate manufacturing processes
• Lead spray drying and related unit operations, including process ownership
• Oversee process scale-up, technology transfer, and validation activities (e.g., PPQ)
• Interpret process data to drive data-driven decision-making and improvements
• Provide troubleshooting support for spray drying and powder handling challenges
• Lead technology transfers for Spray Dried Intermediates and ensure robust transfer
• Drive process fit, scalability assessments, and equipment capability evaluations
• Support regulatory inspections and maintain inspection-ready documentation

Skills

Technical leadership

Process ownership

Cross-functional collaboration

Data-driven decision-making

Troubleshooting

Process scale-up

Technology transfer

Regulatory compliance

Continuous improvement

spray drying

Education

Degree in Chemical Engineering or related field

Tools

Spray drying equipment

PSD morphology analysis

Material characterization tools

Job description

We have an exciting opportunity for a Senior Process Engineer, Technical Operations - Small Molecule Drug Product (Spray Drying) 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 OSD and drug product intermediates, including spray dried materials.

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.

Key Responsibilities

Technical & Process Leadership

Provide technical leadership for drug product intermediate manufacturing processes, including:

Spray drying (solution and suspension systems)

Particle engineering and solid-state control

Powder handling, isolation, and post-processing

Act as process owner / SME for spray drying and associated unit operations and equipment

Lead technical input to the Capital Project Team, supporting:

Process design and control strategy development

Commissioning, qualification, and startup readiness

Lead or coordinate process scale-up, technology transfer, and validation activities (e.g. PPQ)

Interpret process and material data (e.g. PSD, morphology, residual solvent, solid-state properties) to drive data-driven decision-making and performance improvements

Provide advanced troubleshooting support for spray drying and powder handling challenges (e.g. yield losses, sticking, fouling, variability in particle attributes)

Technology Transfer & Commercialization

Lead or play a key role in execution of technology transfers for Spray Dried Intermediates

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

Drive:

Process fit and scalability assessments

Equipment capability and process comparability evaluations

Own or guide development and optimization of:

Process descriptions and control strategies

Support integration and industrialization of new particle engineering and enabled formulation technologies

Process Optimization & Operational Excellence

Partner with Manufacturing to ensure safe, efficient, and reliable spray drying and intermediate processing operations

Identify, prioritize, and implement improvements in:

Particle consistency (PSD, morphology, solid-state form)

Process robustness and yield

Throughput and cycle time

Lead or drive continuous improvement initiatives aligned with operational excellence

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

Spray drying variability (e.g. outlet temperature control, atomization efficiency)

Powder handling challenges (e.g. flowability, electrostatics, losses)

Downstream processing impacts (e.g. blend uniformity, compaction behavior where relevant)

Monitor process trends and critical quality attributes to proactively identify risks and optimization opportunities

Contribute to debottlenecking, cleaning optimization, and campaign efficiency improvements

Compliance & Documentation

Ensure all activities are conducted in compliance with cGMP, safety (including ATEX/containment where applicable), and environmental standards

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

Own or approve key:

Batch records

Process specifications and control strategies for intermediates

Support regulatory inspections and audits, ensuring inspection-ready processes and documentation

Ensure high standards of data integrity, particularly for materials characterization and process data

Cross-functional Collaboration & Influence

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

Provide clear technical direction and influence decision-making for product introduction and lifecycle management

Lead or contribute to cross-functional initiatives, driving alignment and execution

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

Qualifications

To excel in this role, you will have:

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

Typically 5+ years' experience in drug product intermediate, spray drying, or pharmaceutical process development/manufacturing
(PhD may offset experience)

Strong experience in spray drying and/or particle engineering processes

Understanding of scale-up principles for spray dryers (lab to commercial scale)

Experience in solid-state characterization and material science (e.g. PSD, morphology, amorphous/crystalline control)

Demonstrated involvement in:

Technology transfer

Process validation (PPQ)

Commercial manufacturing support

Working knowledge of cGMP and regulatory expectations

Experience with downstream processing into drug product (e.g. blending, compaction) is desirable