Manufacturing, Science and Technology Lead
Sobi - Swedish Orphan Biovitrum AB (publ)
full-time
Posted on:
Location Type: Remote
Location: Raleigh • North Carolina • United States
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Salary
💰 $125,000 - $172,000 per year
Job Level
About the role
- 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.
Requirements
- University education in Chemistry, Pharmacy or similar.
- +5-10 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Drug Product manufacturingGMP complianceCMC developmentprocess validationrisk assessmentCAPAanalytical specificationsstability programsoral dosage formshard-gelatine capsules
Soft Skills
leadershipdecision makingcross-functional teamworkprioritizationcommunication