Technical Lead

Sobi•Raleigh, NC

1d•$125,000 - $165,000

About The Position

Location Requirement: 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 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

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 raport 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
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

Benefits

Competitive compensation for your work
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
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.