Senior Technical Ops Lead, Small Molecule Drug Product

Biopharma Careers

Elkton (KY)

On-site

USD 142,000 - 224,000

Full time

12 days ago
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Job summary

Biopharma Careers seeks an Associate Director of Technical Operations for Small Molecule Drug Product at Elkton Site, VA. You will provide technical leadership for startup, tech transfer, validation, and ongoing commercial manufacture of oral solid dosage forms.

Leading cross-functional teams, you will ensure safe, compliant, and reliable process performance while driving continuous improvement and lifecycle management. Strong background in OPD operations and cGMP is essential.

Qualifications

  • Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related field.
  • Experience with oral solid dose manufacturing and process development.
  • Strong knowledge of process engineering, scale-up, validation and GMP.

Responsibilities

  • Lead process scale-up, technology transfer and validation activities for oral solid dose processes.
  • Drive improvements in process performance, yield, robustness, and impurity control.
  • Support design, commissioning, qualification and startup readiness for capital projects.
  • Ensure compliance with cGMP and regulatory expectations across processes.
  • Collaborate with cross-functional teams including Engineering, Quality and Supply Chain.

Skills

Oral solid dose
Process engineering
Scale-up
cGMP
DeltaV
Process validation

Education

Chemical Engineering / Pharmaceutics / Pharmaceutical Sciences (BSc/BEng/Masters)
Related discipline

Tools

DeltaV

Job description

Biopharma Careers seeks an Associate Director of Technical Operations for Small Molecule Drug Product at Elkton Site, VA. You will provide technical leadership for startup, tech transfer, validation, and ongoing commercial manufacture of oral solid dosage forms.

Leading cross-functional teams, you will ensure safe, compliant, and reliable process performance while driving continuous improvement and lifecycle management. Strong background in OPD operations and cGMP is essential.

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