Senior MS&T Engineer: Process Transfer & Optimization

Novo Nordisk; Bloomington (IN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Dental & Vision coverage

401K with company match

Paid time off + holidays

Tuition assistance

Life & disability insurance

Employee referrals

Job summary

Novo Nordisk in Bloomington, IN seeks a process leadership expert to support technology transfer, optimization and lifecycle management of biopharma manufacturing processes. You will partner with cross-functional teams to ensure compliant, reliable operations and continuous improvement aligned with quality standards.

The role requires a degree in related field with 4+ years of relevant experience, and involves authoring technical docs, leading risk assessments, and coaching colleagues across

Qualifications

• Bachelor's degree in related field with four years of relevant experience, or higher degrees with reduced experience requirements.
• Experience in GMP manufacturing, process transfer, and lifecycle management is required.
• Ability to author and review technical documents and batch records.

Responsibilities

• Provide SME leadership for Drug Substance operations including bioreactor, chromatography, and PK/TFF processes.
• Review GMP scale process descriptions and create process flow diagrams from descriptions.
• Lead equipment and process improvement assessments and implement robust changes.
• Monitor daily GMP data to track process performance and quality.
• Prepare and approve batch records, SOPs, BOMs, sample plans and campaign reports.
• Train team members and mentor interns/co-ops.
• Collaborate cross-functionally to transfer and maintain processes site-wide.
• Support risk assessments, deviations, changes and CAPAs with root-cause analysis.

Skills

SME expertise

Process development

GMP knowledge

Cross-functional collaboration

Technical documentation

Training others

Education

Bachelor's Degree in related field

Master's Degree in related field

Doctorate in related field

Job description

Novo Nordisk in Bloomington, IN seeks a process leadership expert to support technology transfer, optimization and lifecycle management of biopharma manufacturing processes. You will partner with cross-functional teams to ensure compliant, reliable operations and continuous improvement aligned with quality standards.

The role requires a degree in related field with 4+ years of relevant experience, and involves authoring technical docs, leading risk assessments, and coaching colleagues across