MSAT Technical Lead – Drug Substance

Sobi - Swedish Orphan Biovitrum AB (publ)

MSAT Technical Lead driving small molecules drug substance manufacturing at Sobi. Leading process validation, project execution, and collaboration with external manufacturers for clinical and commercial products.

Posted 6/17/2026full-timeRemote • Morrisville • North Carolina • 🇺🇸 United StatesSenior💰 $153,000 - $211,000 per yearWebsite

About the role

Key responsibilities & impact

Subject matter expert (SME) for Small Molecules Drug Substance Manufacturing.
Process owner of Small Molecules process validation for Sobi products.
Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM.
Participate in internal activities related to (external) manufacturing, such as process changes, major/critical deviations, risk assessments, and CAPAs.
Issue, review, and approve applicable internal and external SOP’s and manufacturing instructions.
Review and supervise the setup, execution, and documentation of technical studies, qualifications, and validations.
Write and review applicable sections of the APR/PQR.
Write and review applicable sections in registration files, variations, and market expansion.
Support in sourcing evaluation of new Small Molecules contract manufacturers and participation in developing supply and quality agreements.
Lead the technical part of a product transfer, scale-up activities, validations, and oversee manufacturing of Small Molecules processes at external manufacturers for Sobi projects in the clinical and commercial phase.
Be aware of external biopharmaceutical manufacturing technology advancements, understand and introduce new technologies, and how they may be applicable to process innovation, cost, or yield improvement.

Requirements

What you’ll need

University degree in Chemistry, Biology, Biotechnology, Pharmacy, or similar
10+ years of experience in the development and manufacturing of small-molecule drug substances for clinical and commercial use
5+ years of experience in a commercial setting leading the technical pieces of product transfer, scale-up, and validation
Experience reviewing applicable sections of the APR/PQR
Scientific and technical background in CMC development and manufacturing of drug substances, small molecules
Experience with regulatory guidelines, regulatory authorities communication, and file documentation
Experience overseeing external vendors such as CMOs, CDMOs, etc.
Demonstrable experience working in a cross-functional team with the ability to multitask, prioritize, and be an effective decision-maker

Benefits

Comp & perks

Competitive compensation for your work
Generous time off policy
Opportunity to broaden your horizons by attending popular conferences
Emphasis on work/life balance
Collaborative and team-oriented environment
Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

process validationmanufacturing process improvementtechnical studies documentationproduct transferscale-up activitiesvalidationsAPR documentationPQR documentationCMC developmentregulatory guidelines

Soft Skills

leadershipmultitaskingprioritizationdecision-makingcross-functional teamwork