Jobs · Engineering · Virginia

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

Merck · Elkton, VA · 2 days ago
Engineering$117k–$184k/yrFull-time

About the role

We are seeking a Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Spray Drying) to join our team. This role offers the opportunity to lead and optimize processes for drug product intermediates, including spray drying and particle engineering, in a forward-thinking, research-intensive biopharmaceutical setting.

Responsibilities

  • Provide technical leadership for drug product intermediate manufacturing processes, including spray drying, particle engineering, and powder handling.
  • Lead technical input to the Capital Project Team, supporting equipment selection, process design, and control strategy development.
  • Coordinate process scale-up, technology transfer, and validation activities, ensuring data-driven decision-making and performance improvements.
  • Interpret process and material data to drive continuous improvement initiatives and resolve process challenges.
  • Partner with global R&D and network sites to ensure robust transfer of formulation and particle engineering knowledge.
  • Support integration and industrialization of new particle engineering and enabled formulation technologies.
  • Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards.

Requirements

  • Minimum of a degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or a related field.
  • Typically 5+ years’ experience in drug product intermediate, spray drying, or pharmaceutical process development/manufacturing (a 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), and commercial manufacturing support.
  • Working knowledge of cGMP and regulatory expectations.
  • Experience with downstream processing into drug product (e.g., blending, compaction) is desirable.

Qualifications

  • 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.

Key Skills

  • Technical leadership in drug product intermediate manufacturing processes.
  • Leadership in process scale-up and technology transfer.
  • Strategic thinking and continuous improvement initiatives.
  • Collaboration across manufacturing, quality, engineering, supply chain, and R&D teams.
  • Compliance with cGMP and regulatory standards.

Preferred Skills

  • Current experience in the biopharmaceutical industry.
  • Experience with downstream processing into drug product (e.g., blending, compaction).

Benefits

  • Annual bonus and long-term incentive, if applicable.
  • Comprehensive benefits package including medical, dental, vision healthcare, retirement benefits, paid holidays, vacation, and compassionate/sick days.

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