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

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

We are seeking a Senior Process Engineer to lead technical operations for small molecule drug product manufacturing via spray drying at a state‑of‑the‑art site.

Key Responsibilities

• Technical & Process Leadership
  • Provide leadership for drug product intermediate manufacturing processes including spray drying (solution and suspension), particle engineering, powder handling, isolation, post‑processing, and downstream processing into dosage forms.
  • Own and act as SME for spray drying and associated unit operations, leading technical input to the Capital Project Team: equipment selection, process design and control strategy, commissioning, qualification, and startup readiness.
  • Lead or coordinate process scale‑up, technology transfer, and validation activities, such as PPQ.
  • Interpret process and material data (PSD, morphology, residual solvent, solid‑state properties) to support data‑driven decision making.
  • Provide advanced troubleshooting support for spray drying and powder‑handling challenges (yield losses, sticking, fouling, variability in particle attributes).
  • Drive technology transfer and commercialization for spray‑dried intermediates, partner with R&D and network sites, and lead process fit and scalability assessments.
  • Own or guide development and optimization of batch documentation, process descriptions and control strategies, and support industrialization of new particle‑engineering technologies.
  • Lead continuous improvement initiatives, using structured problem‑solving approaches (RCA, DoE) to address variability, equipment challenges, and downstream processing impacts.
  • Monitor process trends and critical quality attributes to identify risks and optimization opportunities.
• Process Optimization & Operational Excellence
  • Partner with Manufacturing to ensure safe, efficient, and reliable spray‑drying operations.
  • Identify, prioritize, and implement improvements in particle consistency, process robustness, yield, throughput, and cycle time.
  • Drive debottlenecking, cleaning optimization, and campaign efficiency improvements.
• Compliance & Documentation
  • Ensure all activities comply with cGMP, safety (ATEX/containment where applicable), and environmental standards.
  • Lead campaign preparation, execution, and post‑campaign review.
  • Own or approve batch records, process specifications, and control strategies for intermediates.
  • Support regulatory inspections and audits, ensuring inspection‑ready processes and documentation.
  • Maintain data integrity for materials characterization and process data.
• Cross‑Functional Collaboration & Influence
  • Act as 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, fostering alignment and execution.
  • Support knowledge sharing and best practice transfer across internal and external networks.

Qualifications

• Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline.
• Typically 5+ years of 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 (PSD, morphology, amorphous/crystalline control).
• Demonstrated involvement in technology transfer, process validation (PPQ), and commercial manufacturing support.
• Working knowledge of cGMP and regulatory expectations.
• Experience with downstream processing into drug product (blending, compaction) is desirable.

Required 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 able 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.

Preferred Skills

• Adaptability, Biopharmaceutical Industry, Change Control Processes, Customer‑Oriented, Data Integrity, Deviation Management, Engineering Standards, Equipment Selection, 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.
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• Current Contingent Workers apply HERE

Compensation & Benefits

The salary range for this role is $117,000.00 – $184,200.00. The successful candidate may be eligible for annual bonus and long‑term incentive, if applicable. A comprehensive package of benefits is offered, including medical, dental, vision, retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days.

EEO Statement

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants 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 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.