Analytical Expert - Pharma Products

Job Description This position is based on the US East Coast (candidates should ideally live within a reasonable distance of Raleigh, NC, or Boston, MA). Key Responsibilities Ensure compliance and relevance of analytical methods (IPC, DS, and DP) and associated Quality Systems, including specifications, for a small molecule product, and all relevant regulatory and legislative requirements. Oversee and manage development as well as analytical routine activities at CLO/CMO; including release testing and stability studies, investigating and solving issues and queries. Support in the design of stability study programs, assessing shelf life, and ensuring the relevance of analytical methods. Lead continuous method verification, including analysis of trend data, establishing and reviewing method lifecycle to maintain, develop, and validate analytical methods to support quality and process understanding. Lead analytical transfer workstreams for drug substance and drug product transfers from development to commercial sites and between commercial sites, method qualifications, and validations, and provide training for external labs. Support the development, refinement, and implementation of the product control strategy by ensuring analytical method capabilities, specifications, and stability data are fully aligned with quality and process understanding. Lead internal activities related to external manufacturing, such as assessments of analytical changes, major/critical deviations, risk assessments, and CAPAs. Oversee the establishment and maintenance of reference materials and responsibility for product-specific method standards and qualified materials (critical reagents), including coordination of shipping of samples and reagents. Write and review applicable sections in registration files, variations, and market expansion. Issue, review, and approve applicable internal and external SOPs. Keep up to date with relevant regulatory and legislative requirements and assessment of testing monographs. Provide support for geographical expansions to new markets. Support process and system improvements to allow effective work within Analytics. Qualifications University education in Analytical Sciences or equivalent. +5-10 years of progressive experience in analytical development, method validation, and QC/QA interactions for small‑molecule, non‑sterile drug products. Demonstrated experience overseeing analytical activities at CLOs/CMOs, including release and stability testing, troubleshooting, investigations, and analytical method life cycle management. Recognized expert in analytical methods for small molecules (HPLC, UPLC, GC, dissolution, residual solvents, impurities profiling, forced degradation, etc.). Demonstrated experience working as part of a cross‑functional team with the ability to lead cross‑functionally, prioritize, and make effective decisions. Experience defining control strategies, including ICH Q2, Q3C, Q3D, M7. Experience with regulatory authorities and guidelines (FDA & EMA), including communication and documentation filing. Fluent in English; intermediate to full proficiency in Chinese is a plus. Background in drug product manufacturing in oral dose a plus, with experience in hard gelatin capsules highly preferred. Strong cross‑functional team player. Ability to act independently and show strong ownership. Excellent communication skills, oral/written. Highly emotionally intelligent with the ability to communicate effectively to build rapport with external and internal partners and stakeholders. Compensation and Total Rewards Base salary range for this role is $125,000-$165,000 . Each individual offer will be determined based on several factors, including experience, qualifications and location. Additionally, this role is eligible for both short‑term and long‑term bonuses. Benefits 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. 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 Sobi - Swedish Orphan Biovitrum AB (publ)