Analytical Expert - Pharma Products

Sobi•Waltham, MA

3h•Onsite

About The Position

Sobi is seeking an Analytical Expert to ensure the compliance and relevance of analytical methods and associated Quality Systems for a small molecule product. This role involves overseeing and managing 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 manage continuous method verification. They will also lead analytical transfer workstreams, support the product control strategy, and oversee internal activities related to external manufacturing. Additionally, the role involves writing and reviewing registration files, SOPs, and providing support for geographical expansions and process improvements within Analytics.

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
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
Responsible for overseeing and managing development as well as analytical routine activities at CLO/CMO; incl. 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 SOP's
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