rare strength
CMC & Manufacturing, Science and Technology Drug Substance Lead
Location
North Carolina
Posted
2 hours ago
Salary
$153K - $211K / year
Seniority
Senior
Job Description
CMC & Manufacturing, Science and Technology Drug Substance Lead
Sobi - Swedish Orphan Biovitrum AB (publ)
• Responsible for Drug Substance (DS) synthesis of a small molecule used in oral dosage forms. • Lead the technical workstreams of manufacturing process transfers from development to commercial site and between commercial sites. • Scale-up activities, process validations and oversee manufacturing of Drug Substance small molecules at external manufacturers for projects in clinical and commercial phase. • Collaborate effectively with external manufacturing partners 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.
Job Requirements
- 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.
- Recognized expert in synthetic organic chemistry and process R&D; experience with deuterated molecules is a plus.
- 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.
Benefits
- 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
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