Analytical Development, Science and Technology Lead at Sobi

Raleigh, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Jun, 26

Salary

172000.0

Posted On

03 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Development, Subject Matter Expert, Quality Systems, Small Molecule, CMC Development, CLO/CMO Management, Stability Studies, Shelf Life Assessment, Method Verification, Method Validation, Analytical Transfer, Control Strategies, Risk Assessments, CAPAs, Registration Filings, SOP Review

Industry

Pharmaceutical Manufacturing

Description

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 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 Qualifications Education/Learning Experience/Work Experience University education in Analytical Sciences or equivalent. +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 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 $125,000-$172,000. 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 Sobi's 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 1,900 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, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re 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 can’t 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 [email protected] Know Your Rights Sobi Location: United States

Responsibilities

The Lead acts as the subject matter expert responsible for delivering compliant, robust analytical methods (IPC, DS, DP) and associated Quality Systems for a small molecule product, ideally supporting transition from Phase 3 to commercial readiness. This role also involves overseeing analytical development and routine activities at CMOs, including stability studies, troubleshooting, and leading analytical transfer workstreams.