CMC & Manufacturing, Science and Technology Drug Substance Lead at Sobi

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

27 May, 26

Salary

211000.0

Posted On

27 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Drug Substance Synthesis, Process Transfers, Scale-Up Activities, Process Validation, External Manufacturing Oversight, GMP Compliance, Risk Assessments, CAPAs, Technical Studies, Registration Files, SOP Review, Analytical Specifications, Synthetic Organic Chemistry, Process R&D, Regulatory Guidelines, Cross Functional Team 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 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 CMC & Manufacturing, Science and Technology Drug Substance Lead will be responsible for: Experienced subject matter expert (SME) and process owner for Drug Substance (DS) synthesis of a small molecule used in oral dosage forms. Lead the technical workstreams of a manufacturing process transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug Substance small molecules at external manufacturers for projects in clinical and commercial phase. Experience in collaborating effectively with external manufacturing partners and to oversee all technical drug substance synthesis aspects (GMP and non-GMP steps). Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs Review and supervise design, set up, execution and documentation of DS related technical studies (CMC development as well as commercial operations), process and equipment qualifications and validations. Write and review applicable sections in registration files, variations and market expansion Issue, review and approve applicable internal and external SOP's and fully oversee correctness and compliance of external manufacturer manufacturing instructions. Contribute during set up of new analytical specifications and stability programs and review changes thereof Support in sourcing evaluation of new Drug Substance small molecules, oral dosage forms alternative contract manufacturers and participation in developing supply and quality agreements. Be aware of modern synthetic organic chemistry methodologies, advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement Qualifications Education/Learning Experience/Work Experience University education in Chemistry, Pharmacy or similar. 10+ years of experience of development and manufacturing of Drug Substance small molecule, non-sterile dosage forms for clinical and commercial use. Ideally for more than 2 molecules. Skills/Knowledge/Languages Recognized expert in in synthetic organic chemistry and process R&D; experience with deuterated molecules is a plus. Scientific and technical background of CMC development and GMP-compliant manufacturing in for small molecule drug substance. Experience of working with external manufacturers Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker Experience of regulatory guidelines (FDA & EMA), regulatory authorities communication and filing documentation. Fluent in English, intermediate to full proficiency in Chinese 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 $153,000-$211,000. 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 and process owner for Drug Substance synthesis of small molecules, leading technical workstreams for process transfers, scale-up, and validation between development and commercial sites. This role involves overseeing manufacturing at external partners and leading internal activities like change assessments, deviations, risk assessments, and CAPAs related to external manufacturing.