Analytical Expert - Pharma Products at Sobi

Waltham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Aug, 26

Salary

165000.0

Posted On

06 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Method Development, Method Validation, QC/QA Interactions, Small Molecule Analysis, HPLC, UPLC, GC, Dissolution Testing, Impurities Profiling, Forced Degradation, Control Strategy Definition, ICH Guidelines, FDA Regulations, EMA Regulations, CMO Management, Cross-functional Leadership

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 part of a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people living with rare diseases. 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 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 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 analytical method life cycle management Skills/Knowledge/Languages 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, 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 Personal Attributes 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. 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. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: 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. The base salary range for this role is $125,000-$165,000. 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

Oversee analytical methods and quality systems for small molecule products, managing routine activities and stability studies at CLO/CMO sites. Lead analytical transfer workstreams and support the implementation of product control strategies to ensure regulatory compliance.