MSAT Technical Lead - Drug Substance; Sr Manager

Location Requirement:
This position may be based near Raleigh, NC or Boston, MA
. The role requires periodic travel between both locations to support cross‑site collaboration and business needs.

• 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 SOPs 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 overseas 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.

• 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.

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

• A competitive 401(k) match to support your financial future.
• Tuition and wellness reimbursements to invest in your personal and professional growth.
• A comprehensive medical, dental, and vision package to prioritize your health and well‑being.
• Additional recognition awards to celebrate your achievements.
• Base salary range: $153,000‑$211,000, with eligibility for short‑term and long‑term bonuses.

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

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