MSAT Technical Lead - Drug Substance (Sr Manager)

MSAT Technical Lead – Drug Substance (Sr Manager) Full-time Sobi Location: United States At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. If this role excites you but you’re unsure if you meet every requirement, we encourage you to apply. Your unique perspective and experiences could be exactly what we need. Science and Technology (SAT) is part of the Global CMC, Science & Technology Department (GCSAT). GCSAT is responsible for the optimization and life-cycle management of Sobi’s clinical and commercial manufacturing and analytical processes across internal and external networks. SAT ensures compliant, reliable, cost-effective, and sustainable manufacturing and testing of our products now and in the future. The SAT team holds the senior scientific and technical knowledge for the manufacturing and analytical testing of Sobi’s clinical and commercial products and is responsible for maintaining the internal and external manufacturing/analytical processes at a validated stage. 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. Responsibilities 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 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 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. Requirements University degree in Chemistry, Biology, Biotechnology, Pharmacy, or similar. 6+ years of experience in the development and manufacturing of small-molecule drug substances for clinical and commercial use. 3+ 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. Compensation and Total Rewards Base salary range: $140,000 - $165,000. Role eligible for short-term and long-term bonuses. Benefits include competitive 401(k) match, tuition and wellness reimbursements, comprehensive medical, dental, and vision package. An Equal Opportunity Employer 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. If qualified individual with a disability or disabled veteran may request reasonable accommodations by emailing [emailprotected] #J-18808-Ljbffr