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

Job description

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 LeadershipProvide 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 & CommercializationLead 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 ExcellencePartner 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 & DocumentationEnsure 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 & InfluenceAct 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 Trans