Analytical Expert - Pharma Products

Sobi • Waltham, NC

6d • $125,000 - $165,000 • Remote

About The Position

Sobi is seeking an Analytical Expert to ensure the compliance and relevance of analytical methods and associated Quality Systems for small molecule products. This role involves overseeing analytical activities at Contract Laboratories Organizations (CLOs) and Contract Manufacturing Organizations (CMOs), including release testing, stability studies, and issue resolution. The expert will support the design of stability programs, assess shelf life, and lead analytical transfer workstreams for drug substance and drug product transfers. They will also contribute to the product control strategy, manage internal activities related to external manufacturing, oversee reference materials, and prepare regulatory documentation. The position requires a strong understanding of regulatory and legislative requirements and the ability to support geographical expansions.

Requirements

• 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.
• 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.

Nice To Haves

• 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.

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.
• Responsible for 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.

Benefits

• Competitive compensation
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
• Competitive 401(k) match
• Tuition and wellness reimbursements
• Comprehensive medical, dental, and vision package
• Additional recognition awards
• Eligible for both short-term and long-term bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree