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

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

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

Act as process 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 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

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 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

Key Skills:

Strong analytical capability with ability to interpret process and material science data

Demonstrated ability to lead technical workstreams or process-focused 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 ownership 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 delivering spray drying and drug product intermediate capability

Take ownership of particle 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

Required Skills:

Adaptability, Biopharmaceutical Industry, Biopharmaceuticals, Change Control Processes, Chemical Engineering, Customer-Oriented, Data Integrity, Deviation Management, Engineering Standards, Equipment Selection, Good Manufacturing Practices (GMP), Maintenance Engineering, Manufacturing Process Validation, Operational Excellence, Pharmaceutical Sciences, Process Optimization, Regulatory Compliance, Root Cause Analysis (RCA), Spray Drying, Strategic Thinking, Teamwork, Technical Leadership, Technical Support, Technical Transfer, Technology Transfer

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click 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 protected characteristics.  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:

EEOC Know Your Rights

EEOC GINA Supplement​

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.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$117,000.00 - $184,200.00

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 at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://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

Search Firm Representatives Please Read Carefully 

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.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

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.

Requisition ID:R407467