Analytical Development, Science and Technology Lead (West Coast based)

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 SOPs and CMO manufacturing instructions. 

• Keep up to date with relevant regulatory and legislative requirements and assessment of testing monographs 

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 smallmolecule nonsterile 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 hardgelatine capsules is a plus 

Personal Attributes 

• 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.

Additional Information :

Compensation and Total Rewards at Sobi

At Sobi we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent ensuring that your contributions are valued and reflected in your overall rewards.

The base salary range for this role is $125000-$172000. Each individual offer will be determined based on several factors including your experience qualifications and location. Additionally this role is eligible for both short-term and long-term bonuses as outlined in the plan details.

All Sobi employees need to demonstrate behaviors in line with Sobis core values: Care Ambition Urgency Ownership and Partnership. Are you ready to be on the Sobi team Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us

We are a global company with over 1900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.

We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.

Sobi Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs job requirements and individual qualifications without regard to race color religion or belief national social or ethnic origin sex (including pregnancy) age physical mental or sensory disability HIV Status sexual orientation gender identity protected veterans and/or expression marital civil union or domestic partnership status past or present military service family medical history or genetic information family or parental status or any other status or protected groups by the laws or regulations in the locations where we operate.

If you are a qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to   

Know Your Rights

Remote Work :

Yes

Employment Type :

Full-time