Biopharma Manufacturing Associate I: Process Transfer & Improvement

Bora Pharmaceuticals; Rockville (MD); On-site; USD 64,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Professional development

Job summary

Bora Pharmaceuticals in Rockville, MD is seeking a Manufacturing Technology Associate I to support drug substance manufacturing operations across late-stage programs. You will collaborate with Manufacturing Operations and BioPharmaceutical Development to support tech transfers, process validations, and routine production at internal sites.

The role emphasizes investigations, data analysis, and continuous improvement, with a focus on cGMP compliance and cross-site collaboration across multiple

Qualifications

• Bachelor's degree in Chemical / Biochemical Engineering, Biology, Chemistry, Biochemistry or related life sciences or engineering field.
• Academic, internship, co-op or professional exposure to biopharmaceutical manufacturing and/or protein purification processes, incl. chromatography, titration and filtration.
• Experience with Deviation, CAPA and Change Control systems.

Responsibilities

• Leads investigations of deviations to determine root cause and product impact; develops corrective action plans.
• Performs detailed data analyses and root cause analyses to identify solutions to complex problems.
• Leads continuous process monitoring and applies statistical tools to improve productivity and robustness.
• Supports technology transfer activities between internal and external sites and partners.
• Authors change controls and coordinates implementation at facilities to improve processes.

Skills

Root cause analysis

Data analysis

Statistical tools

Cross-functional collaboration

Good communication

Documentation

Education

Bachelor's degree in Chemical / Biochemical Engineering

Biology / Chemistry / Biochemistry related field

Tools

Microsoft Office (Word, Excel, PowerPoint)

Job description

Bora Pharmaceuticals in Rockville, MD is seeking a Manufacturing Technology Associate I to support drug substance manufacturing operations across late-stage programs. You will collaborate with Manufacturing Operations and BioPharmaceutical Development to support tech transfers, process validations, and routine production at internal sites.

The role emphasizes investigations, data analysis, and continuous improvement, with a focus on cGMP compliance and cross-site collaboration across multiple