Technical Lead

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• 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

Job Description

Location Requirement:
This position is based on the US East Coast (candidates ideally live near Raleigh, NC or Boston, MA).

Key responsibilites:

• 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 to oversee and manage development as well analytical routine activities at CLO/CMO; incl. release testing and stability studies, investigate and solve issues and queries
• Support in the design of stability study-programs, assessing shelf life and ensuring relevance of analytical methods
• Responsible for continuous method verification including analysis of trend data, establishing and review method lifecycle to maintain, develop and validate analytical methods to support quality and process understanding
• Lead the analytical transfer workstreams of drug substance and drug product transfers from development to commercial site and between commercial sites, method qualifications as well as validations and provide training of 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 to improvements for processes and systems to allow effective work within Analytics

Qualifications

Education/Learning Experience/Work Experience

• 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 lifecycle management of analytical methods

Skills/Knowledge/Languages

• Recognized expert of analytical methods for small molecules (HPLC, UPLC, GC, dissolution, residual solvents, impurities profiling, forced degradation, etc.)
• Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker 
• Experience defining control strategies, including ICH Q2, Q3C, Q3D, M7
• Experience of regulatory guidelines (FDA & EMA), regulatory authorities communication and filing documentation.  
• Fluent in English, intermediate to full proficiency in Chinese is a plus. 
• Background in Drug Product manufacturing in hard‑gelatine capsules is a plus

Personal Attributes

• Strong cross-functional team player
• Ability to act independently and show strong ownership
• Excellent communication skills, oral/written and listening to external and internal partners and stakeholders.

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