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

Job DescriptionWe 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 ResponsibilitiesTechnical & Process LeadershipProvide technical leadership for drug product intermediate manufacturing processes, including:Spray drying (solution and suspension systems)Particle engineering and solid-state controlPowder handling, isolation, and post-processingDownstream processing into dosage forms (e.g. blending, compaction as required)Act as process owner / SME for spray drying and associated unit operations and equipmentLead technical input to the Capital Project Team, supporting:Equipment selection (e.g. spray dryers, atomization systems, powder handling systems)Process design and control strategy developmentCommissioning, qualification, and startup readinessLead 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 improvementsProvide advanced troubleshooting support for spray drying and powder handling challenges (e.g. yield losses, sticking, fouling, variability in particle attributes)Technology Transfer & CommercializationLead or play a key role in execution of technology transfers for Spray Dried IntermediatesPartner with global R&D and network sites to ensure robust transfer of formulation and particle engineering knowledgeDrive:Process fit and scalability assessmentsSpray dryer scale-up strategy (lab pilot commercial)Equipment capability and process comparability evaluationsOwn or guide development and optimization of:Batch documentationProcess descriptions and control strategiesSupport integration and industrialization of new particle engineering and enabled formulation technologiesProcess Optimization & Operational ExcellencePartner with Manufacturing to ensure safe, efficient, and reliable spray drying and intermediate processing operationsIdentify, prioritize, and implement improvements in:Particle consistency (PSD, morphology, solid-state form)Process robustness and yieldThroughput and cycle timeLead or drive continuous improvement initiatives aligned with operational excellenceUse 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 opportunitiesContribute to debottlenecking, cleaning optimization, and campaign efficiency improvementsCompliance & DocumentationEnsure all activities are conducted in compliance with cGMP, safety (including ATEX/containment where applicable), and environmental standardsProvide technical leadership in campaign preparation, execution, and post-campaign reviewOwn or approve key:Batch recordsProcess specifications and control strategies for intermediatesSupport regulatory inspections and audits, ensuring inspection-ready processes and documentationEnsure high standards of data integrity, particularly for materials characterization and process dataCross-functional Collaboration & InfluenceAct as a technical representative across Manufacturing, Quality, Engineering, Supply Chain, and R&DProvide clear technical direction and influence decision-making for product introduction and lifecycle managementLead or contribute to cross-functional initiatives, driving alignment and executionSupport knowledge sharing and best practice transfer across internal and external networksQualificationsTo excel in this role, you will have:Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related disciplineTypically 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 processesUnderstanding 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 transferProcess validation (PPQ)Commercial manufacturing supportWorking knowledge of cGMP and regulatory expectationsExperience with downstream processing into drug product (e.g. blending, compaction) is desirableKey Skills:Strong analytical capability with ability to interpret process and material science dataDemonstrated ability to lead technical workstreams or process-focused projectsExcellent problem-solving skills with structured, science-based approachEffective communicator with ability to influence cross-functional stakeholdersProven ability to manage multiple priorities in a dynamic manufacturing environmentProactive, self-driven mindset with strong focus on ownership and continuous improvementOur CultureWe 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 capabilityTake ownership of particle engineering and intermediate process performance at scaleDevelop as a technical leader in a high-impact, technology-driven environment…we encourage you to apply.#ELKVACOERequired 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 TransferPreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS 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 RightsEEOC 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 ActsThe salary range for this role is$117,000.00 - $184,200.00This 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 .You can apply for this role through (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 OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation:DomesticVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Not ApplicableShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aJob 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. SummaryLocation: USA - Virginia - ElktonType: Full time