Engineer/Scientist, Drug Product Process Development and Manufacturing

Role Summary

Engineer/Scientist, Drug Product Process Development and Manufacturing — lead formulation and external manufacturing efforts for oral solid dosage (OSD) products across our clinical pipeline. This builder role focuses on deep technical know-how, cross-functional collaboration, and driving tech transfers and validation to enable faster delivery of 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 engineering principles such as 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 include regular use of computer and office equipment, clear communication, and occasional movement; comfortable with screen work and focus. Reasonable accommodations may be provided to enable performance.

Skills

• Process design and optimization
• Technology transfer and process validation
• cGMP, regulatory compliance
• Quality systems and risk-based approaches
• Problem-solving, data analysis, root cause investigation
• Cross-functional collaboration and CDMO management

Education

• Bachelor's degree or master's degree in chemical engineering (preferred); or BSc/MS in pharmaceutical sciences or related discipline.