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# MSAT Technical Lead - Drug Substance

- **Company:** Sobi, Inc
- **Location:** Philadelphia, PA, United States (Remote available)
- **Experience:** Expert
- **Salary:** $153,000.0 - $211,000.0
- **Contract:** Permanent contract
- **Skills:** Documentation System, Yield Optimization
- **Published:** June 18, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=ff6d8a719a2d1a14

## About the Role

Do you have experience in Vendor relationship management?, * 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

Personal Attributes

 * Fulfillment of all of Sobi's values
 * Ability to act independently and take initiative
 * Good communication skills, oral/written, and listening
 * Strong team player

## Description

* 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, At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.


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