MSAT Technical Lead, Small Molecule Manufacturing

Swedish Orphan Biovitrum AB (publ); Morrisville (NC); On-site; USD 153,000 - 211,000; Full time

Benefits offered by this job

401(k) match

Tuition reimbursement

Comprehensive medical, dental, and vision package

Recognition awards

Job summary

Swedish Orphan Biovitrum AB (publ) is seeking an expert in Small Molecules Drug Substance Manufacturing in Morrisville, NC. The role requires 10+ years of experience in drug substance development, with responsibilities including leading MSAT projects and supervising technical studies.

The ideal candidate will have a strong scientific background in CMC along with proven experience in leading technical pieces of product transfer and regulatory documentation. The compensation includes a salary range of $153,000–$211,000 and various benefits.

Qualifications

• 10+ years in development and manufacturing of small-molecule drug substances.
• 5+ years in leading technical aspects of product transfer and validation.
• Experience with regulatory authorities communication.

Responsibilities

• Lead MSAT projects for manufacturing process improvement.
• Supervise the technical studies and validations.
• Review and approve internal and external SOPs.

Skills

Small Molecules Drug Substance Manufacturing

Cross-functional team collaboration

Regulatory guidelines knowledge

Technical writing

Education

University degree in Chemistry, Biology, Biotechnology, or Pharmacy

Tools

APRs

PQRs

Job description

Swedish Orphan Biovitrum AB (publ) is seeking an expert in Small Molecules Drug Substance Manufacturing in Morrisville, NC. The role requires 10+ years of experience in drug substance development, with responsibilities including leading MSAT projects and supervising technical studies.

The ideal candidate will have a strong scientific background in CMC along with proven experience in leading technical pieces of product transfer and regulatory documentation. The compensation includes a salary range of $153,000–$211,000 and various benefits.