Analytical Development, Science and Technology Lead
$125k/y-$172k/y
Sobi - Swedish Orphan Biovitrum AB (publ)21 hours ago
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OnsiteFull-timeDirector
Summary
Sobi - Swedish Orphan Biovitrum AB (publ) is seeking an Analytical Development, Science and Technology Lead to join their team in Raleigh, NC. The role involves overseeing analytical development and ensuring compliance with regulatory requirements for small molecule products.
About the Role
As the Analytical Development, Science and Technology Lead, you will be responsible for delivering compliant analytical methods, managing development activities at contract laboratories, and supporting product transitions from development to commercial readiness. You will also oversee method verification, lead analytical transfer workstreams, and ensure alignment of analytical capabilities with quality standards.
About You
Required:
- University education in Analytical Sciences or equivalent.
- 10+ years of experience in analytical development, method validation, and QC/QA interactions for small-molecule drug products.
- Demonstrated experience overseeing analytical activities at contract laboratories.
Preferred:
- Expertise in analytical methods for small molecules (HPLC, UPLC, GC, etc.).
- Experience with regulatory guidelines (FDA & EMA) and filing documentation.
- Fluency in English and proficiency in Chinese.
Benefits
- Competitive compensation for your work.
- Generous time off policy.
- Opportunity to attend popular conferences.
- Emphasis on work/life balance.
- Collaborative and team-oriented environment.
Sobi - Swedish Orphan Biovitrum AB (publ)
Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. We provide sustainable access to innovative therapies in the areas of haematology, immunology, and specialty indications. Today, we employ approximately 1,800 people across Europe, North America, the Middle East and Asia. In 2024, revenue amounted to SEK 26 billion. The Sobi share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at sobi.com.
Raleigh, NC