MSAT Supervisor

Harba; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Harba is searching for a technical lead in Indianapolis, Indiana. This role involves supervising a team of MSAT engineers, ensuring process performance, and overseeing technology transfers from development to manufacturing.

The ideal candidate will possess a Bachelor’s or Master’s degree in Chemical Engineering and at least 7 years of experience in pharmaceutical manufacturing, with strong leadership and technical skills.

Qualifications

• 7+ years of experience in pharmaceutical or biotech manufacturing.
• 2–3 years in a leadership or mentoring role.
• Hands-on experience in upstream or downstream processes.

Responsibilities

• Supervise and mentor a team of MSAT engineers.
• Serve as a technical lead for process optimization.
• Oversee technology transfer of new processes.

Skills

GMP manufacturing operations

Technical writing

Data analysis

Leadership

Communication skills

Education

Bachelor's degree in Chemical Engineering

Master's degree in related field

Tools

DeltaV

PI

Rockwell

Job description

Responsibilities

• Supervise and mentor a team of MSAT engineers and specialists, providing technical guidance and daily support for manufacturing operations.

• Serve as a technical lead and subject matter expert (SME) for process performance, optimization, and troubleshooting activities across drug substance or drug product manufacturing.

• Oversee technology transfer of new processes and products from development to manufacturing, ensuring successful scale-up and validation.

• Review and approve technical documentation, including process descriptions, risk assessments, change controls, and validation protocols/reports.

• Support deviation investigations, root cause analysis, and CAPA implementation to maintain process control and compliance.

• Collaborate cross-functionally with Quality, Validation, Engineering, and Operations to resolve issues and drive continuous improvement.

• Monitor and analyze process performance data and key metrics to ensure consistent quality, yield, and efficiency.

• Lead or participate in regulatory inspections and audits, providing technical input and documentation support.

• Promote a culture of safety, quality, and operational excellence within the MSAT team.

Qualifications

• Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.

• 7+ years of experience in pharmaceutical or biotech manufacturing with at least 2–3 years in a leadership or mentoring role.

• Strong working knowledge of GMP manufacturing operations, process validation, and technology transfer.

• Hands‑on experience supporting upstream, downstream, or fill‑finish processes (depending on site focus).

• Demonstrated ability to lead technical teams, manage priorities, and coordinate cross‑functional initiatives.

• Experience with deviation management, CAPA, and change control systems.

• Excellent data analysis, problem‑solving, and technical writing skills.

• Proficiency with process automation and data trending tools (e.g., DeltaV, PI, Rockwell) preferred.

• Strong communication skills and ability to present technical findings to internal and external stakeholders.