Analytical Development, Science and Technology Lead

Sobi • San Diego, CA

1h • $125,000 - $172,000

About The Position

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 may be based on either the U.S. West Coast (ideally near San Diego, CA) or the East Coast (ideally near Raleigh, NC or Boston, MA). The role requires periodic travel between both locations to support cross‑site collaboration and business needs.
The Analytical Development, Science and Technology Lead is responsible for (including, but not limited to the following:):
Experienced subject matter expert (SME) and scientific owner to deliver compliant, robust and relevant analytical methods (IPC, DS and DP) and associated Quality Systems, including specifications for a small molecule product.
Ideally, profound previous experience to support the transition of a product from phase 3 CMC development to commercial readiness meeting 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, investigating and solve issues and queries.
Support in the design of submission-enabling 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
Design and 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 robust and compliant product control strategies 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 filings, variations and market expansion
Issue, review and approve applicable internal and external SOP's and CMO manufacturing instructions.
Keep up to date with relevant regulatory and legislative requirements and assessment of testing monographs

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 lifecycle management of analytical methods
• 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.
• Strong cross-functional team player with a strong track record to achieve compromise
• Ability to act independently and show strong ownership
• High agility to deliver in a changing environment and be able to build strong scenarios approaches
• Excellent communication skills, oral/written and listening to external and internal partners and stakeholders.

Nice To Haves

• Background in Drug Product manufacturing in hard‑gelatine capsules is a plus

Responsibilities

• Experienced subject matter expert (SME) and scientific owner to deliver compliant, robust and relevant analytical methods (IPC, DS and DP) and associated Quality Systems, including specifications for a small molecule product.
• Ideally, profound previous experience to support the transition of a product from phase 3 CMC development to commercial readiness meeting 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, investigating and solve issues and queries.
• Support in the design of submission-enabling 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
• Design and 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 robust and compliant product control strategies 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 filings, variations and market expansion
• Issue, review and approve applicable internal and external SOP's and CMO manufacturing instructions.
• Keep up to date with relevant regulatory and legislative requirements and assessment of testing monographs

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level