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rare strength
Manufacturing, Science and Technology Lead
Location
North Carolina
Posted
103 days ago
Salary
$125K - $165K / year
Seniority
Senior
Job Description
Manufacturing, Science and Technology Lead
Sobi - Swedish Orphan Biovitrum AB (publ)
• Subject matter expert (SME) and process owner for Drug Product (DP) manufacturing of a small molecule used in non-sterile dosage forms • Oversee all technical drug product manufacturing aspects (fully under GMP) for a small molecule manufactured at an external manufacturer • Lead the technical workstreams of product transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug product with a small molecule at external manufacturers for projects in clinical and commercial phase • Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs • Review and supervise set up, execution and documentation of DP related technical studies (CMC development and 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 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 product small molecules, hard-gelatine capsule based alternative contract manufacturers and participation in developing supply and quality agreements • Be aware of external manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement
Job Requirements
- University education in Chemistry, Pharmacy or similar
- +10 years of experience of development and manufacturing of oral dosage forms, drug products, with small molecules for clinical and commercial use
- Recognized expert in Drug product manufacturing of hard-gelatine capsules
- Scientific and technical background of CMC development and GMP-compliant manufacturing in for small molecule drug products
- Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker
- Experience of working with External manufacturers
- 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
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
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