Senior MS&T Engineer — Process Transfer & Optimization

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

Benefits offered by this job

Leading pay and annual bonus

14 holidays

Health insurance

Dental insurance

Vision insurance

401K with company match

Parental leave

tuition assistance

Life & disability insurance

Employee referral awards

Access to Novo Nordisk products

Job summary

Novo Nordisk in Bloomington, IN is seeking a manufacturing science and technology (MS&T) professional to lead technology transfer, process optimization and lifecycle management of biomanufacturing operations. You will drive cross-functional collaboration to ensure compliant, reliable production and on-time delivery aligned with quality standards.

As SME, you will mentor colleagues, review data, author critical docs, and support risk assessments while advancing site-wide continuous improvement

Qualifications

• Bachelor's Degree in related field from an accredited university.
• Master's Degree with minimum 2 years of relevant experience.
• Doctorate Degree with no minimum experience required.
• We commit to an inclusive recruitment process and equality of opportunity for all applicants.

Responsibilities

• Serve as SME for Drug Substance operations (e.g., bioreactor processes, chromatography, TFF).
• Review GMP process data and create process flow diagrams from descriptions.
• Evaluate equipment and process improvements and document impacts.
• Review daily GMP data to monitor process performance.
• Author and approve batch records, protocols, BOMs, sample plans and SOPs.
• Review validation documents for accuracy and thoroughness.
• Lead risk assessments, deviations, CAPAs and root-cause analysis.
• Mentor and develop coworkers, including Co-ops/interns.
• Collaborate across departments to transfer and maintain processes.

Skills

GMP knowledge

Process transfer

Cross-functional teamwork

Technical leadership

Documentation skills

Education

Bachelor's Degree in related field

Master's Degree in related field

Doctorate Degree in related field

Job description

Novo Nordisk in Bloomington, IN is seeking a manufacturing science and technology (MS&T) professional to lead technology transfer, process optimization and lifecycle management of biomanufacturing operations. You will drive cross-functional collaboration to ensure compliant, reliable production and on-time delivery aligned with quality standards.

As SME, you will mentor colleagues, review data, author critical docs, and support risk assessments while advancing site-wide continuous improvement