Engineer/Scientist, Drug Product Process Development and Manufacturing

Role Summary

Engineer/Scientist to lead formulation and external manufacturing efforts for oral solid dosage (OSD) products across our clinical pipeline. This builder role focuses on developing scalable formulations, driving process optimization, managing CDMO relationships, and ensuring successful tech transfers and validation to advance therapies to patients.

Responsibilities

• Design and optimize robust oral solid dosage formulations for clinical and commercial development.
• Lead tech transfer activities from development to external manufacturing, ensuring seamless scale-up and validation.
• Author and review key technical documentation including batch records, master manufacturing records, and process validation protocols.
• Investigate and resolve deviations and batch failures in collaboration with QA, Regulatory, and CDMO partners.
• Serve as the technical point of contact for CDMO selection, oversight, and performance management.
• Drive process improvements using QbD and risk-based approaches to meet quality, regulatory, and timeline expectations.
• Collaborate with cross-functional teams to ensure end-to-end alignment.

Qualifications

• Bachelor's degree or master's degree in chemical engineering strongly preferred; may consider BSc/MS in pharmaceutical sciences or related discipline.
• 6 to 8 years of experience in oral solid dosage formulation and manufacturing, with a strong foundation in process design, equipment selection, scale-up, and facility fit.
• Demonstrated expertise in technology transfer and process validation, including authoring protocols and leading execution at external sites.
• Proven success managing CDMO relationships and driving performance in outsourced manufacturing environments.
• Deep understanding of cGMPs, regulatory requirements, and quality systems with a process engineering lens.
• Skilled in process modeling, data analysis, and root cause investigation for manufacturing deviations.
• Proactive problem-solver who thrives in ambiguity, acts with urgency, and brings rigor and precision to complex challenges.
• Strong communicator and collaborative team member who contributes without ego.
• The physical and mental requirements of our roles include regular use of a computer, devices or other office equipment, clear communication, and occasional movement.

Skills

• Process engineering
• Technology transfer
• Quality by Design (QbD)
• Root cause analysis
• Regulatory compliance (cGMPs)
• Documentation: batch records, master manufacturing records, validation protocols
• Cross-functional collaboration

Education

• Bachelor's degree or Master's in chemical engineering or related discipline; others considered as noted.

Additional Requirements

• The physical and mental requirements include regular use of a computer and office equipment, clear communication, and occasional movement. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.