CMC & Manufacturing, Science and Technology Drug Substance Lead

Location Requirement

The position may be based in 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.

• Senior subject‑matter expert and process owner for synthesis of a small‑molecule drug substance used in oral dosage forms.
• Lead technical work streams for manufacturing process transfers from development to commercial sites and between commercial sites, including scale‑up, process validations, and oversight of external manufacturing for clinical and commercial projects.
• Collaborate with external manufacturing partners and oversee all technical 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 process‑related technical studies, equipment qualifications, validations, and related quality documentation.
• Write and review applicable sections of registration files, variations, market expansion documents, and internal/external SOPs, ensuring compliance and accuracy.
• Support new analytical specifications, stability programs, and changes thereto.
• Assist in sourcing and evaluating new drug‑substance contract manufacturers and in developing supply and quality agreements.
• Apply modern synthetic organic chemistry methodologies and emerging technologies to drive process innovation, cost or yield improvements.

• University degree in Chemistry, Pharmacy or a related field.
• 10+ years of experience in development and manufacturing of small‑molecule drug substances, non‑sterile dosage forms, for clinical and commercial use (ideally more than two molecules).
• Recognized expertise in synthetic organic chemistry and process R&D, with experience in deuterated molecules a plus.
• Strong technical background in CMC development and GMP‑compliant manufacturing of small‑molecule drug substance.
• Proven experience working with external manufacturers.
• Demonstrated ability to lead cross‑functional teams, prioritize tasks, and make effective decisions.
• Experience with regulatory guidelines (FDA & EMA), communication with regulatory authorities, and filing documentation.
• Fluent in English; intermediate to full proficiency in Chinese is a plus.
• Strong cross‑functional team player, autonomous ownership, agility in dynamic environments, and excellent written and oral communication skills.

• Competitive compensation.
• Generous time‑off policy.
• Opportunities to attend conferences.
• Emphasis on work/life balance.
• Collaborative and team‑oriented environment.
• Positive impact helping patients with rare diseases.

The base salary range for this role is $153,000‑$211,000. Each offer is determined by experience, qualifications, and location, and may include short‑term and long‑term bonuses as outlined in the plan details.

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.

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