Senior OSD Process Engineer - Tech Ops, Scale-Up & Transfer

Biopharma Careers; Elkton (KY); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

Biopharma Careers is seeking a Senior Process Engineer, Technical Operations for small molecule oral solid dosage manufacturing in a U.S. facility. You will lead technical workstreams through process transfer, scale‑up, validation, and commercial manufacture, collaborating with R&D and manufacturing teams.

The role emphasizes process ownership, analytical decision‑making, and continuous improvement to ensure quality, safety, and efficiency across the site.

Qualifications

• Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline.
• Typically 5+ years’ experience in oral solid dose manufacturing, formulation, or process development.
• PhD may offset experience.
• Strong experience in OSD manufacturing operations: roller compaction, tablet compression, film coating.
• Experience in process scale-up and commercialization of solid oral dosage forms.
• Involvement in technology transfer, process validation (PPQ), manufacturing support.
• Good understanding of cGMP manufacturing and regulatory expectations.
• Experience troubleshooting tableting and coating processes in a commercial environment.

Responsibilities

• Provide technical leadership for oral solid dose manufacturing processes, including blending, granulation, roller compaction, tablet compression, film coating.
• Act as process owner / SME for assigned unit operations and equipment.
• Support capital projects with equipment selection, CQV, startup readiness for OSD lines.
• Lead or coordinate process scale‑up, technology transfer, and validation activities (PPQ).
• Analyze and interpret process and product data to drive data‑driven decisions.
• Provide advanced troubleshooting for compression, coating issues.
• Lead technology transfers for oral solid dose products into the facility.
• Drive scale‑up strategy, equipment capability, and process comparability assessments.
• Develop master batch records and process descriptions; support integration of new formulations.

Skills

Technical Leadership

Process Optimization

Root Cause Analysis

Technology Transfer

Oral Solid Dosage

Education

Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline

Job description

Biopharma Careers is seeking a Senior Process Engineer, Technical Operations for small molecule oral solid dosage manufacturing in a U.S. facility. You will lead technical workstreams through process transfer, scale‑up, validation, and commercial manufacture, collaborating with R&D and manufacturing teams.

The role emphasizes process ownership, analytical decision‑making, and continuous improvement to ensure quality, safety, and efficiency across the site.