MSAT Technical Lead - Drug Substance (Sr Manager)

Job Description 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 (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 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. Qualifications 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. Compensation and Total Rewards at Sobi The base salary range for this role is $153,000-$211,000 . Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. Competitive 401(k) match to support your financial future. Tuition and wellness reimbursements to invest in your personal and professional growth. Comprehensive medical, dental, and vision package to prioritize your health and well-being. Additional recognition awards to celebrate your achievements. 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 you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to View email address on click.appcast.io #J-18808-Ljbffr Swedish Orphan Biovitrum AB (publ)