Associate Director, API Ops & Tech Transfer

BioSpace; Stuarts Draft (VA); On-site; USD 180,000 - 240,000; Full time

Job summary

BioSpace is seeking an Associate Director, Technical Operations – Drug Substance at our Elkton Site in Virginia. The role provides technical leadership for startup, technology transfer, validation, and ongoing commercial manufacture of APIs, ensuring safe, compliant, and reliable process performance.

Responsibilities include leading scale-up, process validation, and continued process verification, with a focus on yield improvement, impurity control, and cross-functional governance across

Qualifications

• BSc/BEng/Masters in Chemistry or Chemical Engineering or related field.
• 10+ years in API process development or manufacturing.
• Strong analytical, problem-solving, and communication skills.

Responsibilities

• Provide technical leadership for startup, technology transfer, validation, and ongoing manufacture of APIs.
• Lead scale-up, regulatory readiness, and process validation across assigned processes.
• Drive continuous improvement in yield, cycle time, and impurity control.
• Support CAPA, deviations, OOS investigations with root-cause analysis.
• Collaborate with Engineering, R&D, Quality, and Manufacturing teams.

Skills

Technical leadership

Cross-functional collaboration

Regulatory understanding

Problem solving

Education

Chemistry or Chemical Engineering degree

Tools

DeltaV

Electronic batch records

Job description

BioSpace is seeking an Associate Director, Technical Operations – Drug Substance at our Elkton Site in Virginia. The role provides technical leadership for startup, technology transfer, validation, and ongoing commercial manufacture of APIs, ensuring safe, compliant, and reliable process performance.

Responsibilities include leading scale-up, process validation, and continued process verification, with a focus on yield improvement, impurity control, and cross-functional governance across