Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Spray Drying)

Job Description

We have an exciting opportunity for aSenior 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 providetechnical leadership and process ownership supporting facility design, commissioning, qualification, and startup through totechnology 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 intoprocess lead responsibilities across technology transfer and commercial manufacturing, driving technical excellence and operational performance.

Key Responsibilities

Technical & Process Leadership

• Provide technical leadership fordrug product intermediate manufacturing processes, including:

  • Spray drying (solution and suspension systems)

  • Particle engineering and solid-state control

  • Powder handling, isolation, and post-processing

  • Downstream processing into dosage forms (e.g. blending, compaction as required)

• Act asprocess owner / SME for spray drying and associated unit operations and equipment

• Lead technical input to the Capital Project Team, supporting:

  • Equipment selection (e.g. spray dryers, atomization systems, powder handling systems)

  • Process design and control strategy development

  • Commissioning, qualification, and startup readiness

• Lead or coordinateprocess 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 drivedata-driven decision-making and performance improvements

• Provide advanced troubleshooting support forspray 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 oftechnology transfers for Spray Dried Intermediates

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

• Drive:

  • Process fit and scalability assessments

  • Spray dryer scale-up strategy (lab → pilot → commercial)

  • Equipment capability and process comparability evaluations

• Own or guide development and optimization of:

  • Batch documentation

  • Process descriptions and control strategies

• Support integration and industrialization ofnew particle engineering and enabled formulation technologies

Process Optimization & Operational Excellence

• Partner with Manufacturing to ensuresafe, 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 drivecontinuous 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 todebottlenecking, cleaning optimization, and campaign efficiency improvements

Compliance & Documentation

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

• Provide technical leadership incampaign preparation, execution, and post-campaign review

• Own or approve key:

  • Batch records

  • Process specifications and control strategies for intermediates

• Support regulatory inspections and audits, ensuringinspection-ready processes and documentation

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

Cross-functional Collaboration & Influence

• Act as atechnical representative across Manufacturing, Quality, Engineering, Supply Chain, and R&D

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

• Lead or contribute tocross-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

• Typically5+ years’ experience indrug product intermediate, spray drying, or pharmaceutical process development/manufacturing
  (PhD may offset experience)

• Strong experience inspray drying and/or particle engineering processes

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

• Experience insolid-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 ofcGMP and regulatory expectations

• Experience withdownstream processing into drug product (e.g. blending, compaction) is desirable

Key Skills:

• Strong analytical capability with ability to interpretprocess and material science data

• Demonstrated ability tolead technical workstreams or process-focused projects

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

• Effective communicator with ability toinfluence cross-functional stakeholders

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

• Proactive, self-driven mindset with strong focus onownership and continuous improvement

Our Culture

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.

So, if you are ready to:

• Play a key role in deliveringspray drying and drug product intermediate capability

• Take ownership ofparticle engineering and intermediate process performance at scale

• Develop as a technical leader in a high-impact, technology-driven environment

…we encourage you to apply.

#ELKVACOE

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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Pleaseclick here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protectedcharacteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available athttps://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role throughhttps://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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